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Automated Hematology Analyzer

XP series

XP-300
Instructions for Use

CHAPTER 1 Introduction
CHAPTER 2 Safety Information
CHAPTER 3 Design and Function
CHAPTER 4 Reagents
CHAPTER 5 Initial Operation
CHAPTER 6 Operation
CHAPTER 7 Sample Analysis
CHAPTER 8 Display and Output of Analysis Results
CHAPTER 9 Quality Control
CHAPTER 10 Calibration
CHAPTER 11 Instrument Setup
CHAPTER 12 Cleaning and Maintenance
CHAPTER 13 Troubleshooting
CHAPTER 14 Technical Information
Index

KOBE, JAPAN

Code No. AC580857


PRINTED IN JAPAN
Date of Last Revision: November 2017
© SYSMEX CORPORATION 2012-2017 Software Version: 00-12 and onwards
Table of Contents

Table of Contents
1. Introduction ..................................................... 1-1
1.1 Intended use ...................................................................... 1-3
1.2 Symbols used in this manual ............................................. 1-3
1.3 Trademarks ....................................................................... 1-4
1.4 Abbreviations and units used throughout this manual ....... 1-4

2. Safety Information ........................................... 2-1


2.1 General information ........................................................... 2-1
2.2 Installation ......................................................................... 2-2
2.3 Electromagnetic compatibility (EMC) ................................. 2-2
2.4 Avoiding infections ............................................................. 2-3
2.5 Handling of reagents ......................................................... 2-4
2.6 Maintenance ...................................................................... 2-5
2.7 Disposal of waste fluid, waste materials, and the
device ................................................................................ 2-6
2.8 Warning labels on the instrument ...................................... 2-9
2.9 Operators ......................................................................... 2-13

3. Design and Function ....................................... 3-1


3.1 Front view .......................................................................... 3-1
3.2 Right view .......................................................................... 3-2
3.3 Left side panel ................................................................... 3-3
3.4 Rear side ........................................................................... 3-4
3.5 Front interior ...................................................................... 3-5
3.6 Left side interior ................................................................. 3-6

4. Reagents .......................................................... 4-1


4.1 General information ........................................................... 4-1
4.2 CELLPACK ........................................................................ 4-1
4.3 STROMATOLYSER-WH ................................................... 4-2
4.4 CELLCLEAN ...................................................................... 4-3
4.5 EIGHTCHECK-3WP .......................................................... 4-4
4.6 Symbols used on the labels ............................................... 4-5
4.7 Reagent specifications ...................................................... 4-6

5. Initial Operation ............................................... 5-1


5.1 Introduction ........................................................................ 5-1
5.2 Before installation .............................................................. 5-2
5.3 Preparation of installation location ..................................... 5-4
5.4 Removal of packing tape ................................................... 5-5
5.5 Connection of reagents and waste bottle .......................... 5-7
5.6 Prepare internal printer paper (Printing Paper No. 3) ...... 5-11
5.7 Peripheral devices (optional) ........................................... 5-13
5.8 Connection of a host computer, printer and handheld
bar code reader ............................................................... 5-13
Revised January 2017

5.9 Connection of power cable .............................................. 5-14


5.10 Basic instrument settings ................................................. 5-15

Sysmex XP-300 I
Table of Contents

6. Operation ..........................................................6-1
6.1 Screen display ................................................................... 6-1
6.2 Menu tree ........................................................................... 6-5
6.3 Signal tones ....................................................................... 6-6
6.4 Pneumatic unit stop function .............................................. 6-6
6.5 Timer functions .................................................................. 6-7
6.6 Emergency stop procedure ................................................ 6-7
6.7 SNCS functions ................................................................. 6-7

7. Sample Analysis ..............................................7-1


7.1 Introduction ........................................................................ 7-1
7.2 Outline of analysis modes .................................................. 7-1
7.3 Flowchart of analysis procedure ........................................ 7-2
7.4 Checks prior to operation ................................................... 7-3
7.5 Switching ON ..................................................................... 7-5
7.6 Quality control .................................................................... 7-6
7.7 Specimen requirements ..................................................... 7-7
7.8 Analysis in whole blood (WB) mode .................................. 7-8
7.9 Analysis in pre-diluted (PD) mode ................................... 7-17
7.10 Display of analysis results ............................................... 7-27
7.11 Print and output of analysis results .................................. 7-27
7.12 End of operation (Shutdown) ........................................... 7-28

8. Display and Output of Analysis Results ........8-1


8.1 Latest sample (analysis result screen) .............................. 8-1
8.2 Stored data ...................................................................... 8-11
8.3 Histogram error flags ....................................................... 8-21

9. Quality Control .................................................9-1


9.1 Control material ................................................................. 9-1
9.2 Control methods ................................................................ 9-5
9.3 Quality control process flow ............................................... 9-6
9.4 Control method selection ................................................... 9-7
9.5 Settings for control blood information (QC files) ................ 9-9
9.6 Performing a quality control ............................................. 9-16
9.7 Quality control chart screen ............................................. 9-24

10. Calibration ......................................................10-1


10.1 Calibration flow chart ....................................................... 10-2
10.2 Samples used for calibration ........................................... 10-3
10.3 Establishing reference values .......................................... 10-3
10.4 Automatic calibration ....................................................... 10-4
10.5 Manual calibration ............................................................ 10-9
10.6 Printing calibration history .............................................. 10-12

11. Instrument Setup ...........................................11-1


11.1 Introduction ...................................................................... 11-1
11.2 Possible settings .............................................................. 11-3
Revised January 2017

11.3 Password setting ............................................................. 11-9


11.4 Print settings .................................................................. 11-11

II Sysmex XP-300
Table of Contents

12. Cleaning and Maintenance ........................... 12-1


12.1 Maintenance schedule ..................................................... 12-1
12.2 Check instrument status .................................................. 12-2
12.3 Clean TD chambers and diluted sample lines
(Shutdown) ...................................................................... 12-3
12.4 Check trap chamber level and discard ............................ 12-5
12.5 Clean SRV tray ................................................................ 12-6
12.6 Clean TD ......................................................................... 12-7
12.7 Clean waste chamber ...................................................... 12-9
12.8 Clean SRV ..................................................................... 12-11
12.9 Perform Auto Rinse ....................................................... 12-15
12.10 Clean rinse cup .............................................................. 12-17
12.11 Dispose waste fluid ........................................................ 12-19
12.12 Clean aperture of TD chamber (drain TD chamber) ...... 12-20
12.13 Calibrate LCD screen .................................................... 12-23
12.14 Reset SRV cycle counter ............................................... 12-25
12.15 Adjust pressure and vacuum ......................................... 12-26
12.16 Replace reagent ............................................................ 12-30
12.17 Replace system fuses ................................................... 12-35
12.18 Replace internal printer paper (Printing Paper No. 3) ... 12-36
12.19 List of consumables ....................................................... 12-38

13. Troubleshooting ............................................ 13-1


13.1 When you suspect an error ............................................. 13-2
13.2 Error messages ............................................................... 13-3
13.3 Error messages, possible causes and actions to
revolve the error .............................................................. 13-7
13.4 Print error log ................................................................. 13-22

14. Technical Information ................................... 14-1


14.1 Specifications .................................................................. 14-1
14.2 System limits ................................................................... 14-7
14.3 Print formats .................................................................... 14-9
14.4 Connecting the bar code reader .................................... 14-12
14.5 System of units .............................................................. 14-19
14.6 Functional description .................................................... 14-21
14.7 Warranty ........................................................................ 14-48
14.8 Appendix ........................................................................ 14-49
14.9 GNU GENERAL PUBLIC LICENSE .............................. 14-51

Index
Revised January 2017

Sysmex XP-300 III


Table of Contents

Revised January 2017

IV Sysmex XP-300
Introduction

1. Introduction
Thank you for purchasing the Sysmex XP-300 Automated
Hematology Analyzer.
Before operating this instrument, carefully read this manual.
Keep this manual for further reference.
The XP-300 is a compact instrument, which is designed for easy
operation. For each operating step, the user can adapt the instrument
to his/her needs or existing laboratory conditions by selecting the
appropriate settings. The instrument can also be connected to a host
computer etc., and can be used as one instrument in an analytical
system.
Analysis is possible in whole blood mode as well as in pre-diluted
mode. For this reason, the XP-300 can also be used with a minute
amount of blood (Minimum required volume: 20 L when analyzing
in pre-diluted mode).
The XP-300 performs a reliable analysis of 20 parameters and
displays analysis results in 3 histograms on the LCD screen. In
addition, the analysis data can be printed on the internal/external
printer.

Note:
• Data generated by the XP-300 is not intended to replace
professional judgment in the determination of a diagnosis
or in monitoring patient therapy.
• Operate the instrument as instructed. Reliability of test
results cannot be guaranteed if there are any deviations
from the instructions in this manual. If the instrument fails
to function properly as a result of either the user’s operation
not specified in the manual or the user’s utilization of a
program not specified by Sysmex, the product warranty
would not apply.
Revised January 2017

Sysmex XP-300 1-1


Introduction

Contact address

Manufacturer SYSMEX CORPORATION


1-5-1 Wakinohama-Kaigandori
Chuo-ku, Kobe 651-0073
JAPAN

Authorized Representative European Representative


SYSMEX EUROPE GmbH
EC REP Bornbarch 1, 22848 Norderstedt,
Germany
Phone: +49 40 5 27 26-0
Fax: +49 40 5 27 26-100

Americas SYSMEX AMERICA, Inc.


577 Aptakisic Road
Lincolnshire, IL 60069, U.S.A.
Phone: +1-224-543-9500
Fax: +1-224-543-9505

Asia-Pacific SYSMEX ASIA PACIFIC PTE LTD.


9 Tampines Grande, #06-18,
Singapore 528735
Phone: +65-6221-3629
Fax: +65-6221-3687

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 local Sysmex
representative.

Training courses
For further training information, please contact your Sysmex
representative.

The system described in this manual is marked with a CE-mark


which confirms the compliance with the essential requirements of the
following European Directives:
98/79/EC on in vitro diagnostic medical devices
2011/65/EU on the restriction of the use of certain hazardous
Revised January 2017

substances in electrical and electronic equipment

1-2 Sysmex XP-300


Introduction

The system described in this manual is compliant with the European


ln-Vitro Diagnostic (lVD) Directive and additionally marked with an
EAC-mark which confirms the compliance with applicable
Technical Regulations of Eurasian Economic Union.

1.1 Intended use


The XP-300 shall only be used for in vitro analysis of human blood
or artificial control blood. Any other use is not recommended. The
clinical judgment based on the analysis result must be decided by
doctor(s) in conjunction with the clinical condition and other
examination results.
Only reagents and cleaning solutions stated in this manual can be
used.

1.2 Symbols used in this manual


Risk of Infection, Warning!, Caution! and Information statements are
presented throughout this manual to call attention to important safety
and operational information. Non-compliance with this information
compromises the safety features incorporated in the analyzer.

Risk of Infection
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in infection by pathogens and others.

Warning!
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in death or serious injury to the operator, or
grave property damage.

Caution, Hot!
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in personal injury, such as a burn, to the operator.

Caution, risk of electric shock


Revised January 2017

If this sign is ignored and the instrument is operated


incorrectly, a potentially hazardous situation could
result in electric shock.

Sysmex XP-300 1-3


Introduction

Caution!
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in injury to the operator, adverse effect on
analysis results or property damage.

Information
Indicates what you need to know in order to maintain
instrument performance and prevent damage.

Note:
Indicates information which will be useful in operating the
instrument.

1.3 Trademarks
 Sysmex, EIGHTCHECK, CELLCLEAN, CELLPACK,
STROMATOLYSER and SNCS (Sysmex Network
Communication System) are registered trademarks of
SYSMEX CORPORATION.
 ETHERNET is a registered trademark of Xerox Corporation.
 ISBT128 (International Society of Blood Transfusion) is
copyrighted by and used under License Agreement with
ICCBBA, Inc.

Other company names and product names in this manual are the
trademarks or registered trademarks of their respective owners. The
fact that a trademark is not explicitly indicated in this manual does
not authorize its use.
TM and ® are not explicitly indicated in this manual.

1.4 Abbreviations and units used throughout this manual

Abbreviations

 CBC: Complete Blood cell Count


 GP: Graphic Printer
 HC: Host Computer
 IP: Internal Printer
 LD: Lower Discriminator

Revised January 2017

LL: Lower Limit


 PD: Pre-diluted mode
 QC: Quality Control
 SRV: Sample Rotor Valve

1-4 Sysmex XP-300


Introduction

 T1: Trough Discriminator 1


 T2: Trough Discriminator 2
 TD: Transducer
 UD: Upper Discriminator
 UL: Upper Limit
 WB: Whole Blood mode

Unit

 dL: deciliter (0.1 liter)


 fL: femtoliter (10-15 liter)
 L: microliter (10-6 liter)
 pg: picogram (10-12 gram)

Analysis parameters
This instrument provides results for the following parameters:
 WBC: Number of leukocytes (Analysis principle: DC detection
method)
WBC count in 1 L of whole blood
 RBC: Number of erythrocytes (Analysis principle: DC
detection method)
RBC count in 1 L of whole blood
 HGB: Hemoglobin (Analysis principle: Non-cyanide
hemoglobin analysis method)
Concentration (gram) of hemoglobin in 1 dL of whole blood
 HCT: Hematocrit value (Analysis principle: RBC pulse height
detection method)
Ratio (%) of whole RBC volume in whole blood
 MCV: Mean RBC volume
Mean RBC volume (fL) in whole blood. The volume is
calculated by HCT/RBC.
 MCH: Mean RBC hemoglobin
Mean hemoglobin concentration (pg) per RBC. The
concentration is calculated by HGB/RBC.
 MCHC: Mean RBC hemoglobin concentration
Mean hemoglobin concentration (g/dL). The concentration is
calculated by HGB/HCT.
 PLT: Platelet (Analysis principle: DC detection method)
Platelet count in 1 L of whole blood
 LYM% (W-SCR): WBC-Small Cell Ratio
Ratio (%) of small cells (the lymphocytes) to whole WBC
 MXD% (W-MCR): WBC-Middle Cell Ratio
Revised January 2017

Ratio (%) of middle cells (the mixed population of EO, BASO


and MONO) to whole WBC
 NEUT% (W-LCR): WBC-Large Cell Ratio
Ratio (%) of large cells (the neutrophils) to whole WBC

Sysmex XP-300 1-5


Introduction

 LYM# (W-SCC): WBC-Small Cell Count


Absolute count of WBC-small cells (the lymphocytes) in 1 L
of whole blood
 MXD# (W-MCC): WBC-Middle Cell Count
Absolute count of WBC-middle cells (the mixed population of
EO, BASO and MONO) in 1 L of whole blood
 NEUT# (W-LCC): WBC-Large Cell Count
Absolute count of WBC-large cells (the neutrophils) in 1 L of
whole blood
 RDW-SD: RBC distribution width - SD
The distribution width (fL) at the height of 20% from the
bottom when the peak RBC particle distribution curve is taken
as 100%.
 RDW-CV: RBC distribution width - CV
RBC distribution width (%) calculated from the points defining
68.26% of the entire area spreading from the peak of the RBC
particle distribution curve.
 PDW: Platelet distribution width
The distribution width (fL) at the height of 20% from the
bottom with the peak of platelet particle distribution curve taken
as 100%.
 MPV: Mean platelet volume
Mean volume of platelet (fL)
 P-LCR: Large platelet ratio
Ratio (%) of large platelet volume exceeding 12 fL to the
platelet volume
 PCT: Plateletcrit
Ratio (%) of whole PLT volume in whole blood

Revised January 2017

1-6 Sysmex XP-300


Safety Information

2. Safety Information
Before operating this instrument, carefully read “2. Safety
Information” as well as other instructions in this manual.

2.1 General information

Warning!
• Keep your hair, fingers and pieces of your clothing
away from the instrument while it is running.
You may get injured by getting them caught in the
instrument.
• Should the instrument emit unusual odors or smoke,
turn the main power switch OFF immediately and
unplug the power cable. Using the instrument any
further bears the risk of fire, electric shock or
personnel injury. Contact your local Sysmex
representative immediately for inspection.
• Should the instrument leak fluid, turn OFF the main
power switch immediately, and unplug the power
cable. Using the instrument any further bears the risk
of short circuit, fire, electrical shock or personnel
injury. Contact your local Sysmex representative for
inspection.
• Do not spill liquids such as blood samples or reagent,
nor put metal objects such as staples or paper clips
on the instrument. This could cause a short-circuit or
smoke. In the event of the instrument failure, turn the
main power switch OFF immediately and unplug the
power cable. Contact your local Sysmex
representative for inspection.
• The operator should not touch any electrical circuitry
inside the cover. The danger of electric shock is
particularly high when one’s hands are wet.
• This instrument must not be connected to a power
outlet rated at anything other than specified in the
rating plate.
Please note that the instrument must be grounded.
Failure to do so may cause a fire or electrical shock.
• Avoid damage to the power cable. Do not place any
appliances on the power cable. Do not pull on the
power cord.
• Turn the power supply OFF before connecting
peripheral devices such as a host computer or
handheld bar code reader.

Information
• Before operating this instrument, carefully read this
Revised January 2017

manual. Keep this manual for further reference.


• This instrument must only be installed as instructed
in this manual.

Sysmex XP-300 2-1


Safety Information

cTÜVus mark indicates that the equipment is tested and certified to


comply with the electrical and fire safety regulations controlled by
the US and Canadian governments.
Those tests were conducted thoroughly by TÜV Rheinland that is
accredited as a Nationally Recognized Testing Laboratory (NRTL)
by OSHA (The Occupational Safety and Health Administration) in
the United States, and by SCC (Standards Council of Canada) in
Canada.

2.2 Installation

Caution!
• This instrument must be protected against splashing
water.
• Install in places where there are no adverse effects
from high temperature and humidity, dust or direct
sunlight.
• Avoid shock and vibrations.
• The installation location must be well ventilated.
• Avoid installation near devices causing potential
interference, such as wireless communication
equipment or similar devices, and centrifuges.
• Installation of this instrument in places where
chemicals are stored or hazardous gas may be
present is not permitted.
• Avoid installation near devices that are susceptible to
interference, such as personal computer monitors.
• Use the instrument in places where ambient
temperature ranges between 15°C and 30°C
(optimal at 23°C).
• Use the instrument in places where relative humidity
ranges between 30% and 85%.

2.3 Electromagnetic compatibility (EMC)


This instrument complies with the following IEC (EN) standards:
 IEC61326-2-6:2005 (EN61326-2-6:2006)
Electrical equipment for measurement, control and laboratory
use - EMC requirements
 EMI (Electromagnetic Interference) For this standard the
requirements of class A are fulfilled.
 EMS (Electromagnetic Susceptibility) For this standard the
minimum requirements with regards to immunity are fulfilled.
 This equipment has been designed and tested to CISPR 11 Class
Revised January 2017

A. In a domestic environment it may cause radio interference, in


which case, you may need to take measures to mitigate the
interference.
Do not use this device in close proximity to sources of strong
electromagnetic radiation (e.g. unshielded intentional RF
sources), as these may interfere with the proper operation.

2-2 Sysmex XP-300


Safety Information

Note:
Please always run the instrument with the front cover
closed. The instrument does not comply with the standards
mentioned above while the front cover is left open.

2.4 Avoiding infections

Risk of Infection
• In principle, all parts and surfaces of this instrument
must be regarded as potentially infectious, since this
instrument analyzes patient specimens.
• When performing any task on the instrument, such
as testing, maintenance, preparation, or post
processing, be sure to wear adequate personal
protective equipment, such as protective gloves, a
protective mask, protective eyewear, and a lab coat.
Use only specified tools and parts. After work is
completed, wash hands with disinfectant.
• Be sure to connect the instrument's drain tubing to a
waste tank at the facility or waste container.
• Use a waste tank or waste container that has a
nipple to which the drain tubing can be attached or
that has other means of securing the tubing in place
so as to avoid the risk of waste fluid spillage. In
addition, exercise care so as to avoid such spillage,
for example by regularly verifying that the tube
remains properly secured in place.
• If you are using a waste container, check the
contents regularly and replace the container when
full.
• Never touch waste, or parts having been in contact
with waste, with your bare hands.
• Should you inadvertently come in contact with
potentially infectious materials or surfaces,
immediately rinse skin thoroughly with water, and
follow your hospital or laboratory’s prescribed
cleaning and decontamination procedures.
• Control blood must be regarded as potentially
infectious. Wear protective garments and gloves
when performing quality control.
Revised January 2017

Sysmex XP-300 2-3


Safety Information

2.5 Handling of reagents

Warning!
• If reagents are spilt 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 solution.
Do not mix it with any acidic substances. Also, it
should not come in contact with skin or clothing. If
contact occurs, rinse skin or clothing with plenty of
water to avoid injury or damage, respectively.
• If CELLCLEAN makes contact with the instrument’s
surfaces, it will affect the surface finish and there is
danger of corrosion. Immediately wipe off the
CELLCLEAN with a damp cloth.

Caution!
• Use only the reagents specified in this manual.
• Read the note documentation and labeling on all
reagents.
• Avoid direct contact with reagents. Reagents can
cause irritation of the eyes, skin and mucous
membranes.
• Should you inadvertently come in contact with a
reagent, rinse skin immediately with plenty of water.
• At eye contact, rinse at once with plenty of water and
see a physician.
• If swallowed, seek medical advice immediately.
• Leave the reagent at room temperature (15 - 30°C)
for at least 24 hours before using.
• Avoid contact of dust, dirt or bacteria with the reagent
especially when installing new cubes.
• When reagent is to be stored, store the reagent at
the specified temperature for each 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.
• Take sufficient care to prevent the reagent from
spilling. If reagent is spilt, wipe up with a damp cloth.
Revised January 2017

2-4 Sysmex XP-300


Safety Information

2.6 Maintenance

Risk of Infection
Always wear protective garment and gloves for all
service and maintenance work. Use only specified
tools and parts. After work is completed, wash hands
with disinfectant. Instrument surfaces in contact with
blood is potentially biohazardous.

Caution!
Do not use any organic solvent, acid, or alkaline agent
(except CELLCLEAN that is 1:10 diluted with water).
These will affect the instrument surface's finish and
may cause corrosion or discoloration.

Information
• Do not perform any maintenance work or repair other
than that as specified in this manual.
• When performing out maintenance work, use only
the specified tools and parts. Install only such spare
or replacement parts intended for this equipment.
• Use CELLCLEAN that is 1:10 diluted with water to
clean blood, etc. stained on the instrument surface.
When cleaning the touch panel surface, use a “soft
cloth dampened with ethanol”.
• If the instrument is not operated every day, a “Blank
Error” may occur.
In this case, follow the instructions displayed in the
action message screen.
Revised January 2017

Sysmex XP-300 2-5


Safety Information

2.7 Disposal of waste fluid, waste materials, and the device


Waste fluids, the device, instrument consumables and other waste
materials must be disposed of appropriately in accordance with local
laws applicable to medical, infectious and industrial wastes.

Risk of Infection
To avoid risks of infection, wear protective garments
and gloves for all cleaning or maintenance work. After
completion of work, wash hands with disinfectant.
Otherwise, there is a risk of infection by pathogens.

Warning!
A battery is incorporated in the right side interior of the
instrument in order to keep the stored data. When
disposing of the instrument, remove the battery.
Disposal procedures for batteries should meet the
requirements of all applicable local regulations.

Battery

Right side interior of the instrument


Revised January 2017

2-6 Sysmex XP-300


Safety Information

Waste disposal

Risk of Infection
After becoming waste at end-of-life, this instrument
and its accessories are regarded as infectious. They
are therefore exempted from EU directive 2012/19/EU
(Waste Electrical and Electronic Equipment Directive)
and may not be collected by public recycling to
prevent possible risk of infection of personnel working
at those recycling facilities.

Warning!
• Do not dispose the instrument, accessories and
consumables via public recycling!
• Incineration of contaminated parts is recommended!
Contact your local Sysmex service representative
and receive further instructions for disposal! Follow
local legal requirements at all times.

Caution!
Waste effluents from the instrument may contain
dangerous substances in it and decision about
disposal only has to be made by local water authority.

This symbol is affixed by the requirement by Article 14. (4) of the


WEEE Directive (2012/19/EU), and indicates the waste end-of-life
equipment should not be disposed as unsorted municipal waste and
such equipment shall be collected separately.
Revised January 2017

Sysmex XP-300 2-7


Safety Information

Decontamination

Warning!
Before decontaminating the instrument, be sure to
turn off the power supply and unplug the power cord.
This is necessary to avoid the risk of electric shock.
When cleaning the instrument, always wear protective
gloves and gown. Also, wash hands after
decontamination carefully with antiseptic solution first
and with soap afterwards. Do not open the instrument
for decontamination inside. This is executed only by
Service Technician.

Information
• To ensure decontamination of the instrument outer
surfaces, clean the instrument surface at the end of
the daily work. This has to be executed in the
following three situations;
- Regularly, at the end of a daily work,
- Immediately, during contamination with potentially
infectious material, and
- In advance of repair or maintenance by the field
technical service representative
• Wipe off the instrument surfaces using a cloth
soaked with a suitable decontamination solution.
Please use one-way cloths, e.g. made of paper or
cellulose. The cloth may be moistened in a way only
that no wetness may reach the inside of the
instrument.
• The indicated residence time of the decontamination
solution shall be observed.
• If required, you may afterwards remove normal
contaminations with commercial neutral detergent, in
case these could not be removed by the
decontaminant.
• As a last step the instrument shall be dried with a dry
one-way cloth.
Revised January 2017

2-8 Sysmex XP-300


Safety Information

2.8 Warning labels on the instrument

Front

(1)

(1)

Risk of Infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.

Right side

(1)

(1)

Warning!
• This instrument must be grounded.
• To avoid electric shock, disconnect supply before servicing.
• For the continued protection against risk of fire, replace only with fuse of the specified type and
current rating.
• Never open the instrument’s cover on the back when the main power switch is ON. Do not
Revised January 2017

open this cover unless absolutely necessary.

Sysmex XP-300 2-9


Safety Information

Rear

(1)

(2)

(1)

Risk of Infection
To avoid risks of infection, wear protective garments and gloves for all cleaning or maintenance
work. After completion of work, wash hands with disinfectant. Otherwise, there is a risk of
infection by pathogens.

(2)

Caution!
• Static electricity may damage the electronic circuit via the connectors on the rear panel. Do not
touch connector pins with hands.
• Turn the main power switch OFF before inserting or removing connectors or program cards.

Revised January 2017

2-10 Sysmex XP-300


Safety Information

Front interior

(1) (4)

(2)

(3) (5) (6)

(1)

Caution!
Confirm that the metal knob is between the stoppers.
If it is not, malfunction will occur.

(2)

Caution!
At instrument installation, remove the SRV fixing screw by turning it counterclockwise and
remove the two spacers. Then, clean the surfaces of fixed and rotary valves. Reassemble the
SRV.
Since the hydraulic lines are rinsed with distilled water before shipment, press the start switch
or the [Auto Rinse] button to wash it down. Upon completion of the instrument sequences,
verify that the background count is within the acceptable limit.
* These protection sheets are removed after installation.

(3)

Risk of Infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.

(4)
Revised November 2017

Caution!
When opening the detector cover to clean the TD aperture, follow the instructions in
“12.12 Clean aperture of TD chamber (drain TD chamber)”.
Because there is a risk of electric shock, do not open this cover for any other purpose.

Sysmex XP-300 2-11


Safety Information

(5)

Caution, Hot!
The printer head becomes hot. Use caution.

(6)

Caution!
Static electricity may damage the printer head. Do not touch with your hands.

Revised November 2017

2-12 Sysmex XP-300


Safety Information

2.9 Operators
 Personnel using this instrument must read the Instructions for
Use thoroughly beforehand, and must operate the instrument
correctly.
 Personnel who have less experience operating the instrument
should receive guidance and assistance from an experienced
operator.
 If the instrument requires service, consult the Instructions for
Use for troubleshooting information. If additional repair is
required, contact your Sysmex technical representative.
Revised January 2017

Sysmex XP-300 2-13


Safety Information

Revised January 2017

2-14 Sysmex XP-300


Design and Function

3. Design and Function

3.1 Front view

(1) Front cover


(4) Color LCD screen

(2) Sample probe

(3) Start switch

(1) Front cover


The front cover can be opened to the right by hand. It is opened to replace lyse bottles, check or clean the
interior of measuring unit.

(2) Sample probe


The sample probe is used to aspirate sample in the whole blood and pre-diluted modes.

(3) Start switch


This switch starts whole blood mode analysis and pre-diluted mode analysis.

(4) Color LCD screen


Displays the sample ID number, analysis results, instrument status, error messages, and menus.
Revised January 2017

Sysmex XP-300 3-1


Design and Function

3.2 Right view

(1) System fuses

(2) Main power switch

(3) AC power supply connector

(1) System fuses


The rating will be different depending on the instrument specification and location (see the list of
provided parts in “5.2 Before installation” for details).

Warning!
Before replacing the fuse, always turn off the power and disconnect the power cord.
This is to prevent possible electric shocks.

Caution!
For continued protection against risk of fire or smoke, use the fuse of the specified type and
current rating (see the list of provided parts in “5.2 Before installation”).

(2) Main power switch


Turns ON and OFF the main unit power supply.

Information
Avoid turning this switch ON and OFF continuously in short duration. This will overload the fuse
and may cause the fuse to blow.

(3) AC power supply connector


Using the provided power cord, this connector supplies power from the outlet.
Revised January 2017

3-2 Sysmex XP-300


Design and Function

3.3 Left side panel

(3) Bellows unit


(1) Trap chamber

(4) Air filter


(2) Regulator

(1) Trap chamber


Prevents reagent, etc. from flowing into the vacuum pump of the compressor when an error occurs with
the instrument.

(2) Regulator
Regulates pressure to 0.05 MPa.

(3) Bellows unit


Regulates vacuum to –0.0333 MPa.

(4) Air filter


Prevents dirt and dust from entering the bellows unit.
Revised January 2017

Sysmex XP-300 3-3


Design and Function

3.4 Rear side


(1) Socket for LAN

(2) Socket for bar code reader (6) Serial port


(option)

(3) Socket for graphic printer


(option)
(7) Drain outlet nipple
(4) Socket for LAN
(SNCS service)

(8) CELLPACK inlet nipple


(5) Card slot

(1) Socket for LAN


Connects an Ethernet connector (RJ45) for communication with host computer, etc.

(2) Socket for bar code reader (option)


Connects a handheld bar code reader.

(3) Socket for graphic printer (option)


Connects an optional graphic printer.

(4) Socket for LAN (SNCS service)


Connector for communicating with the Sysmex Network Communication System (SNCS) service.

(5) Card slot


Inserts a program card specified by Sysmex.

Information
Use only program cards specified by Sysmex.

(6) Serial port


Connector for communicating with the host computer.

(7) Drain outlet nipple


This nipple drains waste. It connects with the drain sewer or waste tank.

Risk of Infection
To avoid risks of infection, wear protective garments and gloves for all cleaning or maintenance
work. After completion of work, wash hands with disinfectant. Otherwise, there is a risk of
infection by pathogens.
Revised January 2017

(8) CELLPACK inlet nipple


This nipple aspirates CELLPACK. It connects with the CELLPACK container.

3-4 Sysmex XP-300


Design and Function

3.5 Front interior

(2) SRV
(1) Detector block

(3) Rinse cup

(5) Contrast adjuster

(4) WBC/HGB lyse


(STROMATOLYSER-WH)
(6) Internal printer

(1) Detector block


Incorporates RBC transducer, WBC transducer, and HGB flow cell.

(2) SRV
Makes volumetric measurement of aspirated blood.

(3) Rinse cup


Cleans the sample probe.

(4) WBC/HGB lyse (STROMATOLYSER-WH)


Measures WBC/HGB.

(5) Contrast adjuster


Adjusts the contrast of the LCD screen.

(6) Internal printer


Prints analysis data, error logs, etc.
Revised July 2017

Sysmex XP-300 3-5


Design and Function

3.6 Left side interior

(1) Waste chamber

(2) Pneumatic unit

(1) Waste chamber


Collects waste from transducers and mixing chambers.

(2) Pneumatic unit


Supplies pressure and vacuum.

Note:
Do no open the instrument cover unless your Sysmex service representative asks you to.

Revised January 2017

3-6 Sysmex XP-300


Reagents

4. Reagents

4.1 General information


All reagents used in this instrument are exclusively for use with
Sysmex equipment. Do not use them for any other purpose. Please
follow the warnings for safe handling and usage of each reagent as
given on the reagent packaging, package insert and the instructions
for use.

4.2 CELLPACK
CELLPACK is a diluent used to dilute aspirated analysis samples in
order to measure an RBC count, WBC count, hemoglobin
concentration and platelet count.

Caution!
• Leave CELLPACK at room temperature (15 - 30°C)
for at least 24 hours or longer before using. If a
reagent that has arrived recently is used, a correct
analysis result may not be obtained.
• Use CELLPACK at 15 - 30°C.
When analyzed with reagent of a temperature higher
than 30°C or lower than 15°C, a correct analysis
result may not be obtained.
• Do not allow CELLPACK to freeze.
• CELLPACK is solely intended for use with Sysmex
reagents and analyzers.
• If other reagents are used, the product performance
of Sysmex instruments cannot be guaranteed.
• Do not use any left-over CELLPACK. Always use
new CELLPACK.
• Take care to prevent dust, dirt, bacteria, or other
materials from entering the reagent after it is opened.
Otherwise, there is a possibility that proper analysis
cannot be performed.
• Do not use CELLPACK that shows signs of
contamination or instability, such as turbidity or
discoloration.

Information
Storage and shelf life after first opening
• Store CELLPACK at 1 - 30°C.
• The expiration date is shown on the container.
Revised January 2017

• Once opened (connected to the instrument), product


stability of the reagent is a maximum of 60 days. In
this case, however, make sure to store CELLPACK
at 1 - 30°C.

Sysmex XP-300 4-1


Reagents

4.3 STROMATOLYSER-WH
STROMATOLYSER-WH is a reagent that lyses RBC for accurate
WBC count determination, WBC tri-modal size distribution analysis
and hemoglobin level measurement.

Caution!
• Leave STROMATOLYSER-WH at room temperature
(15 - 30°C) for at least 24 hours or longer before
using. If a reagent that has arrived recently is used, a
correct analysis result may not be obtained.
• Use STROMATOLYSER-WH at 15 - 30°C.
When analyzed with reagent of a temperature higher
than 30°C or lower than 15°C, a correct analysis
result may not be obtained.
• Do not allow STROMATOLYSER-WH to freeze.
• STROMATOLYSER-WH is solely intended for use
with Sysmex reagents and analyzers.
• If other reagents are used, the product performance
of Sysmex instruments cannot be guaranteed.
• Do not use any left-over STROMATOLYSER-WH.
Always use new STROMATOLYSER-WH.
• Take care to prevent dust, dirt, bacteria, or other
materials from entering the reagent after it is opened.
Otherwise, there is a possibility that proper analysis
cannot be performed.
• Do not use STROMATOLYSER-WH that shows
signs of contamination or instability, such as turbidity
or discoloration.

Information
Storage and shelf life after first opening
• Store STROMATOLYSER-WH at 2 - 35°C.
• The expiration date is shown on the outer packaging.
• Once opened (connected to the instrument), product
stability of the reagent is a maximum of 90 days. In
this case, however, make sure to store
STROMATOLYSER-WH at 2 - 35°C.
Revised January 2017

4-2 Sysmex XP-300


Reagents

4.4 CELLCLEAN
CELLCLEAN is a strong alkaline detergent used to remove lyse
reagents, cellular residuals and blood proteins remaining in the
hydraulics of the instrument.

Warning!
• Avoid contact with skin, eyes or clothes.
• In case of skin contact, flush the area with water.
• In case of contact with the eyes, rinse immediately
with large amounts of water and seek medical
attention.
• If swallowed, seek medical advice immediately.
• Because CELLCLEAN is a strong alkaline detergent,
do not mix it with any acidic substances.
• CELLCLEAN is classified as corrosive.
R31: Contact with acids liberates toxic gas.
R35: Causes severe burns.
S26: In case of contact with eyes, rinse immediately
with plenty of water and seek medical advice.
S36/37/39: Wear suitable protective clothing, gloves
and eye/face protection.
S45: In case of accident or if you feel unwell, seek
medical advice immediately (show the label where
possible).

Information
Storage and shelf life after first opening
• Store CELLCLEAN in a dark place at 1 - 30°C.
• The expiration date is shown on the outer packaging.
• Avoid exposure to direct sunlight.
Revised January 2017

Sysmex XP-300 4-3


Reagents

4.5 EIGHTCHECK-3WP
EIGHTCHECK-3WP is control blood for testing the precision and
accuracy of hematology analyzers.

Risk of Infection
Always wear protective garments and gloves when
using EIGHTCHECK-3WP. After completion of work,
wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can
occur.

Information
Storage and shelf life after first opening
• Store EIGHTCHECK-3WP in a dark place at 2 - 8°C.
• The expiration date is shown on the reagent’s
packaging.
• Once opened, this reagent should be used within
7 days.

Revised January 2017

4-4 Sysmex XP-300


Reagents

4.6 Symbols used on the labels


Signs and symbols used on reagent containers, packages and carton boxes for the instrument are as
follows:

Caution!
Important information about the handling of reagents is noted on their containers or
the package insert. Use the reagents after fully understanding the descriptions.

Xn
Corrosive (Hazardous class in the
Harmful (Hazardous class in the EU)
EU)

In vitro diagnostic medical device Keep away from sunlight

Manufacturer Use no hooks

Authorised Representative in the


This way up
European Community

Consult instructions for use Keep away from rain

Temperature limitation Stacking limit by number

Biological risks Fragile; handle with care

Use by Corrugated recycles

Batch code Serial number


Revised January 2017

Catalogue number

The design of the symbols may differ from the actual product.

Sysmex XP-300 4-5


Reagents

4.7 Reagent specifications

Brand name Volume Storage temp. Usage temp. Shelf life after Composition
first opening
CELLPACK 20 L 1 - 30°C 15 - 30°C 60 days Sodium chloride 6.38 g/L
Boric acid 1.0 g/L
10 L Sodium tetraborate 0.2 g/L
EDTA-2K 0.2 g/L
STROMATOLYSER-WH 500 mL×3 2 - 35°C 15 - 30°C 90 days Organic quaternary
ammonium salts 8.5 g/L
Sodium chloride 0.6 g/L
CELLCLEAN 50 mL 1 - 30°C 15 - 30°C – Sodium Hypochlorite
(available chlorine
concentration 5.0%)

Revised January 2017

4-6 Sysmex XP-300


Initial Operation

5. Initial Operation

5.1 Introduction
This product is an In-vitro diagnostic medical device.
A Sysmex service representative is responsible for unpacking,
installing, and initial setup of the product to ensure its proper and
safe operation.
The next several pages will give some essential information on this
instrument.

Note:
When the connection of a graphic printer (option) to this
instrument is intended, contact your Sysmex service
representative.

In case relocation becomes necessary after installation, contact your


Sysmex service representative.
Pay careful attention to this because if relocation, etc. of the
instrument is conducted by the customer, issue occuring as a result
will not be covered under warranty even within the warranty period.
Revised January 2017

Sysmex XP-300 5-1


Initial Operation

5.2 Before installation


Check that there is no damage on the main unit of the XP-300. Also,
check the quantity of provided parts.

List of provided parts for XP-300

No. Part No. Description Quantity


120V 230V 240V
1 AU553517 XP-300 Instructions for Use (N.A.) 1 – –

1 AC580857 XP-300 Instructions for Use – 1 1


(ENGLISH)

2 923-8092-8 Power Cord No. 15 (C-2/N. AMERICA) 1 – –

2 265-7153-5 TA-6P(A)+TA-5(A) H05VV-F – 1 –

2 265-4733-2 Power Cord No. 7687 – – 1

3 943-1781-1 Cubitainer Spout Kit No. 1 (20 L) 1 1 1

4 973-3041-7 Float Switch No. 23 Assy 1 1 1

5 367-1051-9 Tray No. 20 1 1 1

6 442-5338-7 Tube Polyurethane 3m 3m 3m


4 mm ID × 6 mm OD

7 442-5340-5 Tube Polyurethane 6m 6m 6m


6 mm ID × 9 mm OD

8 423-1776-2 Mini-pet No. 10 (1 mL) 2 2 2

9 933-3601-9 Transducer Brush No. 1 1 1 1


Revised January 2017

5-2 Sysmex XP-300


Initial Operation

No. Part No. Description Quantity


120V 230V 240V
10 266-5011-3 Fuse 250V 4A ST4-4A-N1 2 – –

10 AX880901 Fuse 250V 3.15A 50T032H – 2 2

11 266-6743-4 Clamp LWS-85-2.5W 1 1 1

12 BJ312875 Printing Paper No.3 1 1 1

Note:
Item No. 4 (973-3041-7 Float Switch No. 23 Assy) is pre-installed in the main unit front interior at the
factory.
Revised January 2017

Sysmex XP-300 5-3


Initial Operation

5.3 Preparation of installation location


To ensure that the instrument performs to its full extent, it should be installed at an appropriate place.
 Select a place where the power supply is conveniently located.
 Do not place any heavy objects on top of the instrument.
 Secure a space for maintenance and service. Giving consideration to heat radiation by the
instrument, provide at least 50 cm clearance between the wall and the instrument’s side, rear and
top panels.
You may need some more desktop space if an optional graphic printer is connected.
The dimensions of the instrument are shown below. The power cord is 1.8 m long.

Width (mm) Depth (mm) Height (mm) Weight (kg)


Main unit 420 355 480 30

480

420

355

Revised January 2017

5-4 Sysmex XP-300


Initial Operation

5.4 Removal of packing tape


(1) Peel off the fixing tape of the outer cover gently.

(2) Open the front cover of the main unit.


(3) Remove the protective film from the LCD screen.
(4) Remove the SRV protection sheets.
1) Remove the SRV fixing screw.
2) With the fixed and rotary valves separated sufficiently, remove the protection sheets.
3) Return the SRV and the SRV fixing screw to their original positions.
4) Set the provided Tray No. 20.

SRV fixing screw

Tray No. 20 Protection sheets


Revised January 2017

Sysmex XP-300 5-5


Initial Operation

(5) Remove the pneumatic unit fixing screws (2 pcs). Keep these screws for future use.

Fixing screws

(6) Remove the rubber caps of the reagent connection nipples. Keep these rubber caps for future
use.
(7) Remove the factory-installed protective plate.

Rubber caps

Protective plate
Revised July 2017

5-6 Sysmex XP-300


Initial Operation

5.5 Connection of reagents and waste bottle

Prepare reagent

Prepare the reagents and connection kits shown below.

Type Description Volume Connection Kit


PK-30L CELLPACK 20 L Cubitainer spout kit No.1 (for 20 L)
CPK-310A CELLPACK 10 L (a separate kit required)
SWH-200A STROMATOLYSER-WH 500 mL × 3 Float Switch No. 23 Assy

Caution!
• Take care not to spill reagent on to the instrument. If it spills, wipe it off immediately using a
damp cloth.
• If it comes into contact with your skin, wash it off using plenty of water.
• If a reagent enters your eye, wash it out immediately using plenty of water, and seek medical
treatment at once.
• After unpacking, be sure not to allow dust or dirt to come into the reagent. Use up CELLPACK
within 60 days from the unpacking date, and STROMATOLYSER-WH within 90 days.

Note:
When using the CELLPACK (10 L), a separate cubitainer spout kit is required. Contact your Sysmex
service representative.
Revised January 2017

Sysmex XP-300 5-7


Initial Operation

Connect CELLPACK

(1) Prepare the following reagent tube.


Tube Polyurethane 4 mm ID × 6 mm OD ....... 1 pc

Information
Cut the tube to an appropriate length, and connect it. When the diluent (CELLPACK) tube is
more than 2 m long, it may be impossible to have reagent aspirated.

(2) Connect CELLPACK inlet aspiration nipple behind the unit and the nipple of the cubitainer
spout kit No. 1 with the tube polyurethane.
(3) Set the cubitainer spout kit No. 1 to the CELLPACK container.

Cap

Cubitainer spout kit No. 1

CELLPACK inlet nipple

Tube polyurethane 4 mm ID × 6 mm OD

Cubitainer spout kit No. 1

CELLPACK

Information
Revised January 2017

• Avoid setting the diluent (CELLPACK) at a level higher than the instrument. Otherwise, the
reagent may flow into the vacuum line, possibly damaging the instrument.
• After connecting the tube, do not pull it by force for reagent replacement.

5-8 Sysmex XP-300


Initial Operation

Connect STROMATOLYSER-WH

(1) Gently remove the dust-protection bag containing the Float Switch No. 23 Assy that is
connected to the main unit.
(2) Install the float switch to STROMATOLYSER-WH. Then, set it on to the table.

Float Switch No. 23 Assy

STROMATOLYSER-WH

Connect waste line

(1) Prepare the following waste line tube.


Tube Polyurethane 6 mm ID × 9 mm OD ....... 1 pc
(2) Connect an end of the tube polyurethane to the drain outlet nipple behind the unit. Connect the
other end of the tube to the waste sewer in the lab.
If the waste sewer is not available, connect it to a waste tank.

Information
• Cut the tube to an appropriate length, and connect it.
• The maximum waste line length is 6 m. Since waste is removed from the system by
pressurized air, the waste tank may be located at the same height as, or lower than, the drain
outlet nipple. Otherwise the waste may flow back into the system, which will result in a
malfunction.
Revised July 2017

Sysmex XP-300 5-9


Initial Operation

(3) Arrange and tie the diluent and waste line tubings as shown in the figure using the clamp
provided LWS-85-2.5W.

CELLPACK inlet nipple

Drain outlet nipple

Tube polyurethane 6 mm ID × 9 mm OD

Clamp LWS-85-2.5W

Waste
container
Pass the tubing through here.

Caution!
When bundling the tubings using the clamp, its sharp edges can cause injury. Use caution.

Revised January 2017

5-10 Sysmex XP-300


Initial Operation

5.6 Prepare internal printer paper (Printing Paper No. 3)


(1) Open the front cover of the main unit.
(2) Push down the lock lever.
Lock is released and the printer cover is pulled open toward the
Lock lever front.
(3) Mount the new printer paper.
Printer cover

New printer paper


(Printing Paper
No. 3)

(4) Pass the printer paper through along the paper guides.

Paper
guide

(5) Push the printer cover back in position until it locks.


Press the button (paper feed button) to confirm that the
printer paper is fed correctly.

Information
• Be sure to set the printer paper straight in the right
direction. If the printer paper is crooked, the paper may jam.
• Make sure the printer cover is securely closed.
If the cover is not securely closed, a printing error or
incorrect output may result.

Printer head

Caution, Hot!
The printer head becomes hot. Use caution.
Revised July 2017

Caution!
Static electricity may damage the printer head. Do not
touch with hands.

Sysmex XP-300 5-11


Initial Operation

(6) Cut off any printer paper extending from the upper part of the
printer.

(7) Close the front cover of the main unit.

Revised July 2017

5-12 Sysmex XP-300


Initial Operation

5.7 Peripheral devices (optional)

Caution!
When connecting peripheral devices, this instrument
must be switched off.

Graphic printer

 Prints analysis information and analysis data.


 Prints histograms.

Handheld bar code reader

 Scans the bar code on the sample tube and automatically inputs
the sample ID number.

5.8 Connection of a host computer, printer and handheld bar code reader
Connect to each instrument with connecting cables.

Socket for LAN

Socket for bar code reader Serial port


(option)

Socket for graphic printer


(option)

Socket for LAN


(SNCS service)

Information
No connection cable for peripheral devices is provided with this instrument.

Note:
When using a host computer or printer, see “Host Output” or “Printer” in “11.2 Possible settings” for
settings relevant to data output.
Revised January 2017

Refer to “14.4 Connecting the bar code reader” and the bar code reader manual for detailed information
on the connection of a bar code reader.

Sysmex XP-300 5-13


Initial Operation

5.9 Connection of power cable


Connect the provided power cord to the power supply outlet.

Power cord

Connect to the power supply outlet

Warning!
Be sure to ground the instrument. Improper grounding may cause electrical shock.

Revised January 2017

5-14 Sysmex XP-300


Initial Operation

5.10 Basic instrument settings

Note:
In this chapter, only the settings relevant to the instrument
installation are described. For details on all possible
settings, see “11. Instrument Setup”.

Date and time settings

In order to have analysis results properly identified, it is important to


have the date and time set correctly.
(For details about LCD screen display and operations, see
“6.1 Screen display”.)

Note:
When time changes to summer or winter time, respectively,
the clock must be corrected manually.

(1) Press the [Menu] button at the Ready status.


The Menu screen will appear.

(2) Press the [Settings] button.


The Settings menu screen will appear.

Note:
If a password has been set, the password input screen will
appear. Enter the password. No password is set when the
instrument is shipped; the password input screen will not
appear, until a password is set.
Revised January 2017

Sysmex XP-300 5-15


Initial Operation

(3) Press the [Date/Time] button.


The initial Date/Time setting screen will appear.

(4) Press the Format display column to select a date display format.
Display format Example of display (for February 3, 2012)
[yyyy/mm/dd] 2012/02/03
[mm/dd/yyyy] 02/03/2012
[dd/mm/yyyy] 03/02/2012
The underlined format is the initial setting.
(5) Press the Year display column.
The date input dialog will appear.
(For details about the numerical keys dialog, see “Numerical
keys dialog” in “6.1 Screen display”.)
(6) Enter the year, and press the [Ent.] button.
If an incorrect value was entered, press the [C] button and enter
the correct value again.
(7) Enter the month and day in the same way as when entering the
year.

Information
If an incorrect date was entered (e.g. 4/31 or 2/29 in a
year which is not a leap year), a beep sounds.
Reenter the correct date.

(8) Press the [] button to bring up the second Date/Time setting
screen.
(9) Enter the hour and minute in the same way as when entering the
year.
(10) Press the [Save] button to update the settings.
The setting update confirmation dialog will appear.
 Press the [OK] button to update the changed settings.
 Press the [Cancel] button to close the dialog, and setting can
be continued.
* Press the [Top] button on the setting screen. The setting stop
confirmation dialog will appear.
Press the [OK] button to return to the Main screen without
Revised January 2017

changing the settings. Press the [Cancel] button to close the


dialog and continue to change settings.
For details about confirmation dialogs, see “Dialog screen”
in “6.1 Screen display”.

5-16 Sysmex XP-300


Initial Operation

Adjusting the contrast of the LCD screen

The LCD contrast can be adjusted with the contrast adjuster located
underside of the LCD panel. It can be reached by opening the front
cover. Slide the adjuster to the right to darken the LCD, and to the
left to brighten it.

Note:
If no operation is performed on the LCD screen for a certain
period of time, the LCD backlight illuminance will decrease
automatically to conserve electric power (backlight dimmer
Contrast adjuster timer function). Touch any portion on the LCD screen to
return to a normally illuminated LCD screen.

Underside of LCD
Revised January 2017

Sysmex XP-300 5-17


Initial Operation

Revised January 2017

5-18 Sysmex XP-300


Operation

6. Operation

6.1 Screen display


To a large extent, the instrument is menu-driven. Composed of 3
display areas (system area, data processing area and basic operation
area), the LCD screen also displays the operation status and analysis
progress.

Main screen/Menu screen

After turning the power ON, the Sysmex logo appears, and the
startup operation is performed. Then the Main screen will appear.
Analysis operation is performed on the Main screen. When the
[Menu] button on the Main screen is pressed, the Menu screen will
appear.

The menu to select a required function is displayed on the Menu


screen. Auxiliary operations such as instrument maintenance and
settings are performed from this screen. Press the [Top] button on
the upper right of the screen to return to the Main screen from the
Menu screen.

System area
(1) (2) (3) (4) (5) (6) (7) The following information is displayed in the system area on the
upper part of the LCD screen.
(1) button: Prints or deletes the displayed data. This button
also displays a menu screen related to the
SNCS function.
(2) button: Used only for the SNCS function to save the
displayed screen image in bmp format.
For details, see “Screen saving method (Print
screen)” in “6.7 SNCS functions”.
(3) Instrument status indicator
Displays the status of the instrument. The status display shows
5 types of conditions for the instrument: [Ready], [Aspirating],
[Running], [Not Ready] and [PU Sleep].
Revised January 2017

[Ready]: Analysis can be started.


[Aspirating]: Sample is being aspirated.
[Running]: Analysis is being performed.

Sysmex XP-300 6-1


Operation

[Not Ready]: Analysis has stopped. The analysis


cannot be started (when using the
menu or when an error that causes the
analysis to stop occurs, etc.).
[PU Sleep] (blinking): Pneumatic unit operation has stopped.
(4) Screen name
Displays the screen name currently displayed in the Data
Processing area.
Main, Result, Menu, Settings, etc.

(5) button: Executes the paper feed of the printer built


(Paper feed button) in the front interior of the instrument. This
button is effective on any screen as long as
no dialog window is displayed.

(6) button: This button blinks only when an error


(Help button) occurs.
Displays the Action Message screen when
an error occurs, and displays the Error List
screen when 2 or more errors occur at the
same time.

(7) / / button:
The [Menu] button is indicated when the
Main screen is displayed, and it changes into
the [Top] button or [Back] button when any
other screen than the Main screen is
displayed.

Data processing area


The Data Processing area at the center of the LCD screen changes
together with the screen contents.

Basic operation area


The messages and the buttons are displayed in the Basic Operation
area at the bottom of the LCD screen.
Press the corresponding button to execute a basic menu operation
and the cursor operation.
Revised January 2017

6-2 Sysmex XP-300


Operation

Action message screen

This screen appears when an error has occurred and the button
has been pressed.
Follow the instructions on this screen to easily perform a recovery
process.

Dialog screen

Dialog includes the “Error dialog” when errors occur, the


“Confirmation dialog” when settings are changed, and the
“Numerical keys dialog” for entering numerals.
Dialog appears at the top of the screen displayed at that time. Buttons
at the bottom of the screen are inactive at this time.
Error dialog

Confirmation dialog

Display column

Sample ID
The Main screen sample ID, setting values, and other items which
1 can be changed by the operator appear as white boxes with shadows.
These boxes are referred to as “display columns” in the Instructions
for Use.
Press on a display column to input information.

Selections

For settings which require the selection of one setting from multiple
Type 1 Type 1
options, the options are displayed when the display column is
Type 2 pressed. Press the selection to input that value. If all of the options
cannot be displayed on the screen, the [more] button is displayed in
Type 3
the options area. Press the [more] button to change the displayed
Type 4 options.
more
Revised January 2017

Sysmex XP-300 6-3


Operation

Numerical keys dialog

The numerical keys dialog appears for entering numerals. The


7 8 9 buttons displayed differ depending whether numerical keys or
4 5 6 alphabetical keys are chosen. But the operations are the same.
1 2 3 0 - 9 : Enter numerals.
0 C / , _ , . : Enter symbols.
ALPH Ent. C : Erases one character in the case of an
input of characters (when the
[ ALPH ALPH] button is displayed).
Changes the entered value to zero in the
case of an input of numerals (when the
ALPH [ALPH] button is not displayed).

Ent. : Confirms the value which was input,


and closes the numerical keys dialog.
Also, alphabetic characters may be entered.
ALPH ALPH
alph ALPH
NUM Pressing the ALPH once changes the key dialog to alph or NUM .
Press this switching button to change the characters which are
displayed and which can be input.
ABC Press this button
once to enter “A”,
twice to enter “B” and
three times to enter “C”.
Pressing the button four times returns to “A”.
While entering alphabetic characters, the characters are not
confirmed. To confirm the character, press another button or the
[Ent.] button.

[Example] Entering “ABCDe”


Button operation Input status Explanation
ALPH Changes to alphabetical capital letter mode.
ABC
A Inputs “A” (not confirmed).
Ent. A Confirms “A”.
ABC ×2 AB Inputs “B” (not confirmed).
Ent. AB Confirms “B”.
ABC ×3 A BC Inputs “C” (not confirmed).
DEF
A BCD Confirms “C”. Inputs “D”.
alph
A BCD Confirms “D”.
Changes to alphabetic small letter mode.
def ×2 A BCD e Inputs “e” (not confirmed).
Ent. A BCD e Confirms “e”.
Ent. Confirms complete entry. Closes numerical keypad.
Revised January 2017

Note:
While the alpha or numerical keys are displayed on the screen, other buttons cannot be operated.

6-4 Sysmex XP-300


Operation

6.2 Menu tree

Auto Rinse
Main QC
Drain TD Chamber

Result Clean Transducer

Clean W. Chamber
Shutdown
Status Display

Menu Calibration LCD

Print Error Log


Str.Data
SRV reset
Chg.Reag
Auto Calib.

Maint.
Manual Calib.

Calib. Print Cal.His.

Settings System

Date/Time
QC Chart

Patient Limits
PU Sleep
Quality Control

Product ID

Host Output

Printer

Network

Password Setting

Print Settings
Revised January 2017

Sysmex XP-300 6-5


Operation

6.3 Signal tones


This instrument indicates different situations by 4 distinct signal
tones.
(1) Key tone (Short beep)
Beeps for about 0.1 seconds when pressing a button which is
active input.
(2) Input errors (Long beep)
Beeps for about 1 second when pressing a button which is not
active input. Beep sounds (beep, beep, beep) when the
pneumatic unit is stopped.
(3) Analysis error
Continuously beeps if the instrument detects an error, and stops
the alarm sound when the [OK] button of the error dialog
displayed on the LCD screen is pressed. Settings can be used to
change the sound volume.
See “11. Instrument Setup”.
(4) Tone at sample aspiration
Usually: A single “beep” when the start switch is pressed;
“beep, beep” when aspiration is finished.
Sample No. “0” or in pre-diluted mode:
Beep sounds (beep, beep, …) continue from pressing
the start switch until aspiration ends.

Information
When an alarm is sounded, the alarm sound can be
stopped if the [OK] button of the error dialog displayed
on the LCD screen is pressed. Press the button
to display the help menu. All other buttons are not
functional during an alarm.

6.4 Pneumatic unit stop function

Automatic stop function

This instrument, when left non-operating for 15 minutes, automatically


stops the pneumatic unit. This function prevents the hydraulic line
from becoming dry, saves power consumption and extends component
service life. In addition, with this function, analysis-ready status can be
resumed faster than by turning on the power.
Pressing the start switch, the instrument will return to “Ready” status.

Manual stop function


Revised January 2017

This instrument stops the pneumatic unit when the [PU Sleep] button
on the Menu screen is pressed.
Pressing the start switch, the instrument will return to “Ready” status.

6-6 Sysmex XP-300


Operation

6.5 Timer functions


This instrument includes 2 types of timers.
(1) LCD backlight dimmer timer
Purpose: Reduces power consumption and extends backlight
lifetime.
Operation: Dims the backlight.
Timing: Activates when instrument is left for approx. 10
minutes with no screen operations.
Cancel: Touch any part of the LCD screen.
(2) Shutdown warning timer
Purpose: Suggests that the operator initiate the shutdown
sequence.
Operation: Displays the shutdown warning message.
Timing: Activates after 24 hours.
Cancel: Perform shutdown, then turn the main power switch
OFF-ON.

6.6 Emergency stop procedure


When there arises the need to stop the instrument urgently because of
power outage, etc., in the laboratory, turn off the instrument power
switch.

6.7 SNCS functions


The Sysmex Network Communication Systems (SNCS) is a support
service that connects the Customer Support Center and customers’
products via the web for the online provision of remote instrument
maintenance and quality control.
The following pages describe its functions and operation procedures.

Analyzer Customer Support Center

Screen
image

Data transmission
(QC result, operation log, etc.)
Revised January 2017

Web information service

SNCS overview (image)

Sysmex XP-300 6-7


Operation

SNCS service contract

You need to sign up the SNCS service contract to use the SNCS
service. For details about the SNCS service contract, contact your
local Sysmex service representative.

Online QC

When you perform a quality control analysis, the analysis result is


automatically transmitted to the SNCS server together with the QC
file and instrument information.

Maintenance report
(1) Start up report
When the start up of the instrument is complete, the information
that is automatically transmitted to the SNCS server includes:
 Analysis data for background check during start up
(2) Shutdown report
When the shutdown is performed or shutdown has not been
performed for 24 hours after the power is turned on, the
information that is automatically transmitted to the SNCS
server includes:
 Program version
 Cycle counts
 Reagent replacement log and calibration log
(3) Maintenance log
When maintenance is carried out, the maintenance log is
automatically transmitted to the SNCS server.

Error report

When an error occurred or when an error was recovered, the


information about the error that occured is automatically transmitted
to the SNCS server includes:
 Date/time when the error occurred
 Error name/code
Revised January 2017

6-8 Sysmex XP-300


Operation

File transmission

Quality control data, shutdown report, error report and saved screens
using the [PS] button (up to 5 screens) can also be transmitted to the
SNCS server manually.
For details about the screen saving method, see “Screen saving
method (Print screen)” in “6.7 SNCS functions”.
(1) Press the [Out/Del] button on the screen where it is displayed.
The output/delete menu dialog appears.
(2) Press the [File Send] button.
 When transmitting a QC chart:
QC data at the cursor position is transmitted to the SNCS
server.
 When transmitting any data other than QC chart:
The day’s shutdown report, error report and screens saved
using the [PS] button are transmitted to the SNCS server.

Screen saving method (Print screen)

Press and hold the [PS] button (for approximately 1 second) to save
the screen in bmp format (up to 5 screens).

Note:
When there are already 5 screens saved, pressing and
holding the [PS] button (for approximately 1 second) in a
dialog which appears when the [Out/Del] button is pressed
deletes the screen that was first saved.

Press the [File Send] button to transmit the saved screens to the
SNCS server. This is convenient when explaining the displayed
content to your Sysmex service representative.
You cannot use this function when the [PS] button is not displayed
on the screen.
Revised January 2017

Sysmex XP-300 6-9


Operation

Emergency call

When an ‘emergency’ error occurred, you can send an immediate


notice to the SNCS service.
(1) Press the [Out/Del] button on the screen where it is displayed.
The output/delete menu dialog appears.
(2) Press the [EMG.Call] button.
An immediate notice is transmitted to the SNCS server.

Note:
The SNCS function buttons ([PS] button, [File Send] button and [EMG.Call] button) are valid when the
SNCS service setting is made. The setting must be made by a Sysmex service representative only.

Revised January 2017

6-10 Sysmex XP-300


Sample Analysis

7. Sample Analysis

7.1 Introduction
This instrument works in 2 analysis modes: whole blood mode and
pre-diluted mode.
This chapter explains the entire operating procedure from startup to
shutdown of the instrument, as well as the operating procedure in
each analysis mode.

7.2 Outline of analysis modes


 Whole blood (WB) mode
This mode is used to analyze collected samples in the whole
blood status. The tube cap is opened and the sample is aspirated
through the sample probe one after another.
 Pre-diluted (PD) mode
This mode is used to analyze micro samples (samples of smaller
volumes) such as pediatric blood collected from the earlobe or
fingertip.
Analyzes a sample which has been diluted to 1:26 using a micro
tube.
Revised January 2017

Sysmex XP-300 7-1


Sample Analysis

7.3 Flowchart of analysis procedure

Checks prior to operation Page 7-3

Switching ON Page 7-5

Quality control Page 9-1

WB mode analysis PD mode analysis

Page 7-8 Page 7-17

Display of analysis results


• Latest sample Page 8-1
• Stored data Page 8-11

Printout of analysis results


• Latest sample Page 8-10
• Stored data Page 8-19

End of operation (Shutdown) Page 7-28


Revised January 2017

7-2 Sysmex XP-300


Sample Analysis

7.4 Checks prior to operation


Perform the following checks before turning the main power switch
of the instrument ON.

Power cable
 Ensure that the power cable is properly connected.
The power cable must be plugged into an outlet.
 If it is necessary to replace the power cable, contact your
Sysmex service representative.

Internal printer paper (Printing Paper No. 3)

(1) Open the front cover of the instrument, and check that the paper
supply is adequate for the number of samples expected for the
day.
For the replacement procedure, see “12.18 Replace internal
printer paper (Printing Paper No. 3)”.

Information
When the tip of printer paper extends from the upper
part of the internal printer, cut off the paper and then
open the front cover.

(2) Check to see that the paper is properly aligned.

Information
Use only printer paper recommended by Sysmex.

Inspection of reagents
Check to see that the reagents needed for the number of the samples
to be processed for the day are available. If the number available is
such as might become short during the day, make ready the reagents
for use in replenishment. When reagents run out during analysis, the
instrument will automatically come to a stop. Replenish the reagent
that gave an error. Until replenishment is completed, analysis cannot
be resumed. The number of samples that can be analyzed with one
pack of reagent is listed below:
Revised July 2017

Sysmex XP-300 7-3


Sample Analysis

Number of the samples that can be analyzed with one


pack of reagent
CELLPACK: Approx. 600 samples/20 L
(large cubitainer)
Approx. 300 samples/10 L
(small cubitainer)
STROMATOLYSER-WH: Approx. 470 samples/500 mL (bottle)
(The above values are the result of continuous analyses performed in
one day in the whole blood mode. Depending on the use conditions
of the instrument, the result may differ.)

Replenishing reagent
 Make ready a new reagent and make sure that it has not passed
its expiration date. (For detail, refer to “12.16 Replace
reagent”.)

Caution!
• Use a reagent that has been left at room
temperature (15 - 30°C) for more than 24 hours.
• If CELLPACK that has just arrived is used, “Blank
Error” may occur.
• After replenishing a reagent, make sure that its
background count is low before starting sample
analysis.
• As to a reagent that may have frozen, handle it in
accordance with the precautions stated on the
Package Insert. Otherwise, there is a possibility
that proper analysis cannot be performed.
• When replacing the reagent container, take care
not to have dust adhere to the cubitainer spout kit.
• After unpacking, take care to prevent entry of dust,
dirt, bacteria, etc. which could impair proper
analysis.
Shelf life after first opening
CELLPACK 20 L 60 days
STROMATOLYSER-WH 500 mL 90 days

 We recommend preparing “Reagent Replenishment Record” in


which to enter date of replenishment, name of reagent, reagent
lot No., expiration date, name of person who replenished. Such
a record would come in handy.
Revised January 2017

Inspection of waste
If waste is collected in the trap chamber on the left side of the unit
and the waste tank (when provided), discard the waste.

7-4 Sysmex XP-300


Sample Analysis

7.5 Switching ON
After completion of all checks, the main power switch can be turned
ON.
 Turn the main power switch ON.
The LCD screen will be illuminated. The program version will
be briefly displayed.
After the self-check, auto rinse, and background check are
completed, the Main screen will appear.

Self-check
After the main power switch is turned ON, the instrument performs a
self-check. This process takes approximately 2 minutes.
In order to ensure optimal instrument conditions for use at all times,
certain parts require periodic maintenance. This instrument includes
counters which record the number of times that each of these parts
are used. When the main power switch is turned ON, and if either the
counter value exceeds the specified number (see the table below) or
if a certain period of time has passed since the last maintenance, a
message will appear prompting the operator to perform periodic
maintenance. Follow the instructions on the screen and perform the
required maintenance.

Cycles/elapsed time after


Screen display
cleaning
The counter value exceeds 1,500 Messages will appear prompting
or 1 month has passed since the for waste chamber cleaning and
last maintenance. TD cleaning.
The counter value exceeds 4,500 A message will appear prompting
or 3 months have passed since the for SRV cleaning.
last maintenance.

Note:
If an error is detected during the self-check, an error
message appears on the LCD screen. Turn the instrument
main power switch OFF.
If the error persists, contact your Sysmex service
representative.
Revised January 2017

Sysmex XP-300 7-5


Sample Analysis

Background check

After a self-check is normally completed, auto rinse and background


check are performed.
The background check is performed up to 3 times and, if any one of
background counts exceeds the limit, the message [Blank Error] is
displayed on the screen and an alarm is sounded.
 Press the [OK] button on the error dialog. The alarm sound
stops.
 Press the button and the action message will appear.
 Perform the appropriate action according to the action message
screen.
When the auto rinse and background check are normally completed,
the Main screen will appear.
Press the [Result] button and the background check result will
appear.

Note:
“Blank Error” may occur, if the instrument is not operated
for several days.

7.6 Quality control

Information
Always perform a quality control prior to operation as
described in “9. Quality Control”.

Revised January 2017

7-6 Sysmex XP-300


Sample Analysis

7.7 Specimen requirements


Type of specimen
Blood specimens should be collected either by venipuncture for
processing in whole blood mode or micro sampling by skin puncture
for capillary mode processing. For micro sampling the blood can be
obtained from the earlobe or finger of an adult (preferably the latter)
or from the heel of an infant. Ideally, large drops of blood should
exude slowly but spontaneously, and only the very gentlest
squeezing is permissible. If it is necessary to squeeze firmly to obtain
blood, the results are unreliable.

Conditions of collection
Venipuncture specimens should be collected into EDTA
anticoagulant (EDTA-2K, EDTA-3K or EDTA-2Na) and processed
within 4 hours of collection. If specimens cannot be processed within
4 hours, they should be refrigerated at 2 - 8ºC. Before processing
refrigerated specimens should be allowed to warm up to room
temperature (minimum 15 minutes), then mixed, preferably by
rotation, for at least 2 minutes.
Micro-sampling specimens may be diluted directly into the diluent
without utilization of anticoagulant, or may be collected into micro
collection devices with EDTA anticoagulant for dilution at a later
time.

Stability of whole blood specimens


When the specimen is left unrefrigerated for more than 4 hours
certain changes occur within blood cells, which may produce
misleading results of clinical significance. Erythrocytes swell, the
MCV increases, as does the RDW-SD. Platelets also swell resulting
in an increased MPV and P-LCR. The total WBC count may
decrease and the reliability of the electronic differential leukocyte
count diminishes. The degree of change is variable depending on the
specimen and the temperature at which it is stored. These changes are
largely prevented by storage at 2 - 8ºC.
Revised January 2017

Sysmex XP-300 7-7


Sample Analysis

7.8 Analysis in whole blood (WB) mode

Sample preparation

In this mode, the instrument can be used to analyze whole blood to


which an EDTA anticoagulant has been added.
 The blood sample should be collected by vein-puncture.
 Required sample volume: 1 mL or more of whole blood (for a
13 mm diameter sample tube)
500L or more of whole blood (for
a micro tube)
 Aspirated sample volume: Approx. 50 L

Caution!
Blood in which clotting or platelet aggregation has
occurred cannot be analyzed.

Information
• Lysing of red blood cells or platelet aggregation may
occur depending on the anticoagulant, and correct
analysis results may not be obtained. For the
anticoagulant, use either of EDTA-2K, EDTA-3K, or
EDTA-2Na.
• Mix the sample promptly after the blood is drawn. If
mixing is insufficient, platelet aggregation may occur.
• When analyzing a refrigerated sample, take it out of
the refrigerator at least 30 minutes prior to analysis,
to bring it back to room temperature. Once restored
to room temperature, mix the blood sufficiently
before performing analysis.
• Depending on the sample, separation of the WBC
into 3 categories may become less accurate with the
passage of time after the blood is drawn.
• The sample should be analyzed within 4 hours after
collection. If it is not possible to analyze the sample
within 4 hours, store it in a refrigerator at 2 to 8°C
until it can be analyzed.
• Use sample tubes that are 80 mm or less in height.

Note:
All performance claims given in this manual were
Revised January 2017

generated using specimens in EDTA anticoagulant. Results


may be affected by the use of other anticoagulants.
Therefore, each laboratory should develop protocols for
handling specimens collected in their anticoagulants.

7-8 Sysmex XP-300


Sample Analysis

Setting the analysis mode

The instrument is in whole blood mode immediately after the main


power switch is turned ON since the default mode is the whole blood
mode.
To change over to a different analysis mode, proceed as follows:
(1) Be sure the status display indicates “Ready”.
(2) Press the [WB] button.

Information
This setting is kept until the mode is changed – which
is done automatically when performing a quality
control or if the instrument is switched off. When the
[WB] button is pressed, the [WB] button turns red,
and when the [PD] button is pressed, the [PD] button
turns yellow. Always check the analysis mode before
performing the analysis.

Entering a sample ID

The sample ID can be entered by the following 2 methods.


 Entering from numerical keys dialog
 Entering from handheld bar code reader
The sample ID can be set up to 15 characters (alphanumeric
characters, hyphens and space) in length.
With the setting using ISBT128 bar code, up to 13 characters can be
used. For setting method of ISBT128 bar code, see “System” in
“11.2 Possible settings”.
For entering numerals, see “Numerical keys dialog” in “6.1 Screen
display”.

Information
• When setting a sample ID to “0”, the analysis result
will not be stored as data, and it will neither be
printed automatically with the internal/external
printer, nor can it be transferred to the host computer
automatically. Also, sample ID “0” will not be
incremented automatically.
• A sample ID cannot be entered when the pneumatic
unit operation is stopped.
Revised January 2017

Sysmex XP-300 7-9


Sample Analysis

Note:
If no sample ID is entered, it will be incremented by 1 for
each new analysis.
[Examples]:
123  124
999  1000
999999999999999  1
12-3  12-4
12-999  12-000
A999  A000
If the last character of the sample ID is an alphabetic
character, hyphen or space, it will not be counted up
(incremented) automatically.

Entering from numerical keys dialog


(1) Press the [Sample ID] display column on the Main screen.
The alphanumeric input dialog will appear.

(2) Enter the sample ID.


During the sample ID input, the most right character can be
deleted by pressing the [C] button.
(3) Press the [Ent.] button.
The sample ID is defined, and the status changes to Ready for
starting analysis.

Revised January 2017

7-10 Sysmex XP-300


Sample Analysis

Entering from handheld bar code reader


After pressing the [Sample ID] display column, the bar code can be
read in the status of displaying the numerical keys dialog. The
sample ID will be displayed if correctly read.
If the displayed sample ID is not correct, read the bar code again.

Information
Even after pressing the [C] button, the bar code can
be read again.

Make sure that the displayed sample ID is correct, and press the
[Ent.] button.
After the manual input is started, a bar code cannot be read. In this
case, press the [Ent.] button once, then press the [Sample ID]
display column again to read the bar code.

Caution!
• When using a bar code label, affix it properly so it is
flat and smooth without creases or flares.
• A reading error may occur when a bar code reader is
used without a check digit. It is recommended to use
a check digit or to check the sample ID after entry.
For details about check digits, see “ID Bar code
specifications” in “14.4 Connecting the bar code
reader”.
• Do not use any other characters than alpha-
numerics, hyphens and space on the bar code label.
Revised January 2017

Sysmex XP-300 7-11


Sample Analysis

Registering the operator ID

You can register the operator ID of the analysis using the following 2
methods.
 Entering from numerical keys dialog
 Entering from handheld bar code reader
For details about numerical keys operations, see “Numerical keys
dialog” in “6.1 Screen display”.

Note:
• The operator ID can be set up to 15 characters
(alphanumeric characters, hyphens and space) in length.
• Up to 6 operator IDs can be registered.
If there are already 6 IDs registered in memory and a new
ID is entered, the oldest ID is deleted.

Entering from numerical keys dialog


(1) Press the [Operator] display column on the Main screen.
The alphanumeric input dialog will appear.

(2) Enter the operator ID.


During the operator ID input, the most right character can be
deleted by pressing the [C] button.
(3) Press the [Ent.] button.
The dialog closes and the entered operator ID is registered.
Revised January 2017

7-12 Sysmex XP-300


Sample Analysis

Entering from handheld bar code reader


After pressing the [Operator] display column, the bar code can be
read in the status of displaying the numerical keys dialog. If the
displayed sample ID is not correct, read the bar code again.
Make sure that the displayed operator ID is correct, and press the
[Ent.] button.
After the manual input is started, a bar code cannot be read. In this
case, press the [Ent.] button once, then press the [Operator] display
column again to read the bar code.

Caution!
• When using a bar code label, affix it properly so it is
flat and smooth without creases or flares.
• A reading error may occur when a bar code reader is
used without a check digit. It is recommended to use
a check digit or to check the sample ID after entry.
For details about check digits, see “ID Bar code
specifications” in “14.4 Connecting the bar code
reader”.
• Do not use any other characters than alpha-
numerics, hyphens and space on the bar code label.
Revised January 2017

Sysmex XP-300 7-13


Sample Analysis

Selecting the operator ID

Before analysis, you can select the desired operator ID of the analysis
from the registered operator IDs.

Note:
Analysis can be performed even when the operator ID is not
selected.

(1) Press the [ ] button located on the right of the [Operator]


display column on the Main screen.
The operator ID selection dialog will appear.

(2) Select an operator ID.


The operator ID is defined, and the status changes to [Ready]
for starting analysis.
If the operator ID you want to select is not displayed, press
[more] to display all other operator IDs that are registered.

Revised January 2017

7-14 Sysmex XP-300


Sample Analysis

Analyzing samples

Risk of Infection
Wear protective garments and gloves when
performing sample analysis. After completion of work,
wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can
occur.

(1) Make sure that [Ready] is displayed on the instrument status


indicator at the top of the display area and the analysis mode is
set to whole blood mode.

(2) Mix the sample well by inverting the sample tube.

Information
Vigorously mixing the sample can damage blood cells
and cause bubbles to form in the sample. If this
occurs, correct analysis results may not be obtained.

(3) Remove the cap while taking care not to allow blood scatter.

(4) Set the tube to the sample probe, and in that condition, press the
start switch.

Start switch
Revised January 2017

Sysmex XP-300 7-15


Sample Analysis

The analysis starts, the status display indicates [Aspirating].


When sample aspiration is completed, status display
[Aspirating] changes to [Running]. When [Running] is
displayed, the sample can be removed safely.

Caution!
• Do not remove the sample from the sample probe
while [Aspirating] is displayed. If the sample is
removed from the sample probe while [Aspirating] is
displayed, a correct analysis result may not be
obtained.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the sample tube by that
time.
• To remove the sample tube, lower it straight down.
Take care not to bend the sample probe.

Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.

The analysis results for all parameters are displayed about 60


seconds after starting the analysis.

Revised January 2017

7-16 Sysmex XP-300


Sample Analysis

7.9 Analysis in pre-diluted (PD) mode

Sample preparation

In this mode, the instrument can be used to analyze samples which


have been diluted at the ratio of 1:26.
 The blood sample should be collected by skin puncture of the
earlobe, fingertip, or from a babies’ heel.
 Required blood volume (whole blood): Approx. 20L
or more
 Required sample volume (pre-diluted blood): 500 L or more
(for the micro
tube)
 Aspirated sample volume (pre-diluted blood): Approx. 200 L

Information
• Platelet aggregation tends to occur on micro samples
collected from earlobes or fingertips. To prevent
aggregation, the sample should be diluted and
analyzed immediately after collection. If the analysis
is performed more than 30 minutes after the sample
is diluted, correct analysis results may not be
obtained.
• When a sample tube containing a general
anticoagulant is used, lysing of red blood cells or
platelet aggregation may occur depending on the
anticoagulant, and correct analysis results may not
be obtained. For the anticoagulant, use either of
EDTA-2K, EDTA-3K, or EDTA-2Na.

Note:
All performance claims given in this manual were
generated using specimens in EDTA anticoagulant. Results
may be affected by the use of other anticoagulants.
Therefore, each laboratory should develop protocols for
handling specimens collected in their anticoagulants.
Revised January 2017

Sysmex XP-300 7-17


Sample Analysis

Preparing analysis samples in PD mode (1:26 dilution)


(1) Clean a container such as Erlenmeyer flask, beaker, etc. with
CELLPACK and remove any dirt.
(2) Using a syringe, etc., take CELLPACK into a cleaned
container.
(3) Using a probe (500 L), collect 500 L of CELLPACK and
dispense it into the micro tube.
(4) Using a capillary tube, etc., collect 20 L of blood and dispense
it into the micro tube.
(5) Attach the cap and mix well.

Risk of Infection
When preparing PD-mode analysis samples, always
wear protective garments and gloves. After
completion of work, wash hands with disinfectant.
If your hands are contaminated by blood, etc.,
infection of bacteria can occur.

Caution!
A 1:26 dilution sample is prone to platelet
agglutination. So, analyze the sample within 30
minutes after blood dispensing and diluting. If diluent
is dispensed in advance, evaporation and dirt mixing
will result in errors in analysis values. Therefore
prepare one sample at a time.

When preparing a 1:26 dilution sample, use the tools listed below:
 Diluent (CELLPACK)
 Micro tube (MT-40, etc.)
 Capillary tube
 Probe: 500 L
 A container, such as erlenmeyer flask or beaker
 A syringe
Revised January 2017

7-18 Sysmex XP-300


Sample Analysis

Setting the analysis mode

The instrument is in whole blood mode immediately after the main


power switch is turned ON since the default mode is the whole blood
mode.
To change over to a different analysis mode, proceed as follows:
(1) Be sure the status display indicates “Ready”.
(2) Press the [PD] button.

Information
This setting is kept until the mode is changed – which
is done automatically when performing a quality
control or if the instrument is switched off. When the
[WB] button is pressed, the [WB] button turns red,
and when the [PD] button is pressed, the [PD] button
turns yellow. Always check the analysis mode before
performing the analysis.

Entering a sample ID
The sample ID can be entered by the following 2 methods.
 Entering from numerical keys dialog
 Entering from handheld bar code reader
The sample ID can be set up to 15 characters (alphanumeric
characters, hyphens and space) in length.
With the setting using ISBT128 bar code, up to 13 characters can be
used. For setting method of ISBT128 bar code, see “System” in
“11.2 Possible settings”.
For entering numerals, see “Numerical keys dialog” in “6.1 Screen
display”.

Information
• When setting a sample ID to “0”, the analysis result
will not be stored as data, and it will neither be
printed automatically with the internal/external
printer, nor can it be transferred to the host computer
automatically. Also, sample ID “0” will not be
incremented automatically.
• A sample ID cannot be entered when the pneumatic
unit operation is stopped.
Revised January 2017

Sysmex XP-300 7-19


Sample Analysis

Note:
If no sample ID is entered, it will be incremented by 1 for
each new analysis.
[Examples]:
123  124
999  1000
999999999999999  1
12-3  12-4
12-999  12-000
A999  A000
If the last character of the sample ID is an alphabetic
character, hyphen or space, it will not be counted up
(incremented) automatically.

Entering from numerical keys dialog


(1) Press the [Sample ID] display column on the Main screen.
The alphanumeric input dialog will appear.

(2) Enter the sample ID.


During the sample ID input, the most right character can be
deleted by pressing the [C] button.
(3) Press the [Ent.] button.
The sample ID is defined, and the status changes to [Ready] for
starting analysis.

Revised January 2017

7-20 Sysmex XP-300


Sample Analysis

Entering from handheld bar code reader


After pressing the [Sample ID] display column, the bar code can be
read in the status of displaying the numerical keys dialog. The
sample ID will be displayed if correctly read.
If the displayed sample ID is not correct, read the bar code again.

Information
Even after pressing the [C] button, the bar code can
be read again.

Make sure that the displayed sample ID is correct, and press the
[Ent.] button.
After the manual input is started, a bar code cannot be read. In this
case, press the [Ent.] button once, then press the [Sample ID]
display column again to read the bar code.

Caution!
• When using a bar code label, affix it properly so it is
flat and smooth without creases or flares.
• A reading error may occur when a bar code reader is
used without a check digit. It is recommended to use
a check digit or to check the sample ID after entry.
For details about check digits, see “ID Bar code
specifications” in “14.4 Connecting the bar code
reader”.
• Do not use any other characters than alpha-
numerics, hyphens and space on the bar code label.
Revised January 2017

Sysmex XP-300 7-21


Sample Analysis

Registering the operator ID

You can register the operator ID of the analysis using the following 2
methods.
 Entering from numerical keys dialog
 Entering from handheld bar code reader
For details about numerical keys operations, see “Numerical keys
dialog” in “6.1 Screen display”.

Note:
• The operator ID can be set up to 15 characters
(alphanumeric characters, hyphens and space) in length.
• Up to 6 operator IDs can be registered.
If there are already 6 IDs registered in memory and a new
ID is entered, the oldest ID is deleted.

Entering from numerical keys dialog


(1) Press the [Operator] display column on the Main screen.
The alphanumeric input dialog will appear.

(2) Enter the operator ID.


During the operator ID input, the most right character can be
deleted by pressing the [C] button.
(3) Press the [Ent.] button.
The dialog closes and the entered operator ID is registered.
Revised January 2017

7-22 Sysmex XP-300


Sample Analysis

Entering from handheld bar code reader


After pressing the [Operator] display column, the bar code can be
read in the status of displaying the numerical keys dialog. If the
displayed sample ID is not correct, read the bar code again.
Make sure that the displayed operator ID is correct, and press the
[Ent.] button.
After the manual input is started, a bar code cannot be read. In this
case, press the [Ent.] button once, then press the [Operator] display
column again to read the bar code.

Caution!
• When using a bar code label, affix it properly so it is
flat and smooth without creases or flares.
• A reading error may occur when a bar code reader is
used without a check digit. It is recommended to use
a check digit or to check the sample ID after entry.
For details about check digits, see “ID Bar code
specifications” in “14.4 Connecting the bar code
reader”.
• Do not use any other characters than alpha-
numerics, hyphens and space on the bar code label.
Revised January 2017

Sysmex XP-300 7-23


Sample Analysis

Selecting the operator ID

Before analysis, you can select the desired operator ID of the analysis
from the registered operator IDs.

Note:
Analysis can be performed even when the operator ID is not
selected.

(1) Press the [ ] button located on the right of the [Operator]


display column on the Main screen.
The operator ID selection dialog will appear.

(2) Select an operator ID.


The operator ID is defined, and the status changes to [Ready]
for starting analysis.
If the operator ID you want to select is not displayed, press
[more] to display all other operator IDs that are registered.

Revised January 2017

7-24 Sysmex XP-300


Sample Analysis

Analyzing samples

Risk of Infection
Wear protective garments and gloves when
performing sample analysis. After completion of work,
wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can
occur.

(1) Make sure that [Ready] is displayed on the instrument status


indicator at the top of the display area and the analysis mode is
set to PD-mode.

(2) Mix the sample well by inverting the micro tube.

Information
Vigorously mixing the sample can damage blood cells
and cause bubbles to form in the sample. If this
occurs, correct analysis results may not be obtained.

(3) Remove the cap while taking care not to allow blood scatter.
Revised January 2017

Sysmex XP-300 7-25


Sample Analysis

Start switch (4) Set the micro tube to the sample probe, and in that condition,
press the start switch.

The analysis starts, the status display indicates [Aspirating].


When sample aspiration is completed, status display
[Aspirating] changes to [Running]. When [Running] is
displayed, the sample can be removed safely.

Caution!
• Do not remove the sample from the sample probe
while [Aspirating] is displayed. If the sample is
removed from the sample probe while [Aspirating]
is displayed, a correct analysis result may not be
obtained.
• Single beep sounds (beep, beep, beep, …) continue
while aspirating. When aspiration ends, short beep
sounds twice “beep, beep” and the rinse cup lowers
several seconds after [Running] appears on the
screen. Remove the micro tube by that time.
• To remove the micro tube, lower it straight down.
Take care not to bend the sample probe.

Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.

The analysis results for all parameters are displayed about 60


seconds after starting the analysis.
Revised January 2017

7-26 Sysmex XP-300


Sample Analysis

7.10 Display of analysis results


The results of the last analysis are displayed on the LCD screen.
The complete display consists of 4 screen pages. Switch the pages by
pressing the [] or [] button.
For further information regarding the displays, see “8.1 Latest
sample (analysis result screen)”.
Press the [Top] button to return to the Main screen.

Note:
• Analysis results of the last sample can be re-analyzed by
moving the discriminator positions in the histogram. For
details, see “Manual discrimination” in “8.1 Latest sample
(analysis result screen)”.
• If no buttons on the screen are pressed, the screen will
automatically return to the Main screen when the next
analysis can be performed.
Press the [Result] button on the Main screen to display the
analysis results.

7.11 Print and output of analysis results


The analysis results can be printed from the internal/external printer
or output to the host computer.
For details, see “Output of analysis result (latest sample)” and
“Output of stored data” in “8. Display and Output of Analysis
Results”.

Note:
User settings can also be made for automatic output.
(See “11. Instrument Setup”.)
Revised January 2017

Sysmex XP-300 7-27


Sample Analysis

7.12 End of operation (Shutdown)


At the end of the day’s analysis, before the instrument is turned OFF,
the Shutdown sequence should be executed. Executing a Shutdown
cleans TD chambers and diluted sample lines.
Executing a Shutdown:
To be carried out after all analysis have been performed, or at least
once every 24 hours, if instrument is used continuously.

Caution!
If the instrument is used continuously without
performing the Shutdown sequence, protein build-up
on the internal parts may prevent obtaining correct
analysis results, and may damage the instrument.

Information
If the instrument is turned OFF without executing a
Shutdown, water droplets may come out of the rinse
cup or deposits may build-up on the rinse cup.

Note:
• It takes approximately 5 minutes to complete the Shutdown
sequence.
• If you repeatedly restart the instrument after Shutdown, the
shutdown confirmation dialog screen appears each time.

(1) Press the [Shutdown] button at the Ready status.


The shutdown confirmation dialog screen will appear.
 In case the [Cancel] button is pressed, the Shutdown is
canceled, and the instrument returns to the Main screen. Revised January 2017

7-28 Sysmex XP-300


Sample Analysis

Start switch (2) Set the CELLCLEAN to the sample probe, and in that
condition, press the start switch.
While [Aspirating] is being displayed on the screen, keep
holding CELLCLEAN in the same status, as long as the “beep”
is present.

Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water. Otherwise, it can damage the
skin or clothes.

Caution!
• When the sample is being aspirated, [Aspirating]
appears on the screen. Do not remove the
CELLCLEAN from the sample probe while
[Aspirating] is displayed. Otherwise, there is a
possibility that proper aspiration cannot be
performed.
• To remove CELLCLEAN, lower it straight down.
Take care not to bend the sample probe.

(3) Check that the shutdown sequence was completed and that the
shutdown completion screen is displayed.
Turn OFF the main power switch on the right side of the
instrument.
When the [Restart] button is pressed, the Main screen will
appear.
Revised January 2017

Sysmex XP-300 7-29


Sample Analysis

Revised January 2017

7-30 Sysmex XP-300


Display and Output of Analysis Results

8. Display and Output of Analysis Results


After each analysis the results are displayed on the LCD screen. The
analysis result screen is composed of 4 LCD screen pages. The
histogram, volume distribution flag, abnormal data flag, analysis
error flag, and analysis values are displayed.
This instrument can store analysis results in memory and display
them on the screen.
The analysis results can be printed from the internal/external printer
or output to the host computer.

Information
Data stored in memory includes QC analysis results.

8.1 Latest sample (analysis result screen)


Analysis results of the latest sample are displayed on the LCD analysis result screen after the analysis is
completed. Pressing the [Result] button on the Main screen also displays the analysis result screen.
The analysis result screen is composed of the first to fourth screens. Each screen can be switched by pressing
the [] or [] button and displayed in the order as shown in the diagram below.

First analysis result screen Second analysis result screen

Fourth analysis result screen Third analysis result screen


Revised January 2017

Sysmex XP-300 8-1


Display and Output of Analysis Results

First analysis result screen


Displays analysis results of WBC, RBC, HGB, HCT, MCV, MCH, MCHC and PLT parameters.

Analysis mode

Sample ID Date and time of analysis


Operator ID
Instrument error flag
Histogram error flag
Numeric value
abnormal flag
Analysis data

Second analysis result screen


Displays analysis results of WBC, W-SCR, W-MCR, W-LCR, W-SCC, W-MCC and W-LCC parameters, or
alternatively WBC, LYM%, MXD%, NEUT%, LYM#, MXD# and NEUT# parameters.

Analysis mode

Sample ID Date and time of analysis


Operator ID
Instrument error flag

WBC histogram
Analysis data

Revised January 2017

8-2 Sysmex XP-300


Display and Output of Analysis Results

Third analysis result screen


Displays analysis results of RBC, MCV, RDW-SD, RDW-CV, PLT, PDW, MPV, P-LCR and PCT
parameters.

Analysis mode

Sample ID Date and time of analysis


Operator ID
Instrument error flag

RBC histogram
Analysis data

PLT histogram

Fourth analysis result screen


Displays analysis results of WBC research parameters (ResearchW, ResearchS, ResearchM, ResearchL).

Analysis mode

Sample ID Date and time of analysis


Operator ID

Instrument error flag

WBC histogram
Analysis data

* For details about WBC research parameters, see “2. WBC research parameters” in “14.6 Functional
description”.
Revised January 2017

Sysmex XP-300 8-3


Display and Output of Analysis Results

Description of the analysis result screens

[Out/Del]: Prints the analysis results. For details, see “Output of analysis result
(latest sample)” in “8.1 Latest sample (analysis result screen)”.
[M. Discri.]: Relocates particle distribution discrimination in the histogram and re-
calculates the data. For details, see “Manual discrimination” in
“8.1 Latest sample (analysis result screen)”.
[ID Edit]: Edits the sample ID number. For details, see “Editing the sample ID” in
“8.1 Latest sample (analysis result screen)”.
[] []: Switches the analysis result screens (first - fourth) in display order. For
details, see “8.1 Latest sample (analysis result screen)”.
Sample ID: Displays the sample ID number.
Analysis mode: Displays the analysis mode for the sample.
Displays [WB] for the whole blood mode, and [PD] for the pre-diluted
mode.
Date and time of analysis: Displays the date and time when the analysis result was obtained.
Operator ID: Displays the operator ID of the analysis.
Analysis data: Displays the analysis data of each parameter.
Meanings of signs displayed on the left of the analysis data are as
follows:
Sign Explanation
[!] Value is out of the linearity limit.
[+] Result exceeds the upper patient limit.
[-] Result exceeds the lower patient limit.
[] Result is unreliable.

Note:
The values for [+] and [-] patient limits can be set by the customer.
Check the “Patient Limits” in “11. Instrument Setup”.

If an analysis error has occurred and a value is not available, one of the
following is displayed:
Display Explanation
[+++.+] Value exceeds display range.
[.] Value could not be calculated because of analysis error.
At this time, the analysis error flag, [ERROR] (inverse in
coloration display) appears.
[---.-] Value could not be calculated due to data error, or
volume distribution analysis parameter is not displayed
when the analysis was performed in pre-diluted mode.
Revised January 2017

8-4 Sysmex XP-300


Display and Output of Analysis Results

In 3 histograms (RBC, WBC, PLT), the volume distribution is shown


graphically. Flags are indicated by one of the following:
Flag Explanation
(1) [WL] Relative frequency of WBC-LD has exceeded the range.
(2) [WU] Relative frequency of WBC-UD has exceeded the range.
(3) [T1] T1 discriminator position cannot be determined.
(4) [T2] T2 discriminator position cannot be determined.
(5) [F1] Relative frequency of T1 has exceeded the range.
(6) [F2] Relative frequency of T1 or T2 has exceeded the range.
(7) [F3] Relative frequency of T2 has exceeded the range.
(8) [RL] Relative frequency of RBC-LD has exceeded the range.
(9) [RU] Relative frequency of RBC-UD has exceeded the range.
(10) [DW] Distribution width cannot be calculated.
(11) [MP] There are multiple peaks.
(12) [PL] Relative frequency of PLT-LD has exceeded the range.
(13) [PU] Relative frequency of PLT-UD has exceeded the range.
(14) [AG] The particle count equal to or less than WBC-LD has
exceeded the range.
For details about sample flagging, see “8.3 Histogram error flags”.

WBC histogram: Displays a histogram for WBC.

RBC histogram: Displays a histogram for RBC.

PLT histogram: Displays a histogram for PLT.


Revised January 2017

Sysmex XP-300 8-5


Display and Output of Analysis Results

Manual discrimination

This menu allows relocation of particle distribution discrimination


position and re-calculation of data.

Information
• Manual discrimination can be performed only on the
latest sample.
• Manual discrimination cannot be performed on the
data with sample number 0.

(1) Press the [M. Discri.] button on the analysis result screen.
The manual discrimination parameter selection dialog will
appear.

(2) Press the [WBC], [RBC] or [PLT] button to select a desired


particle distribution for the manual discrimination.
The manual discrimination screen for the selected particle
distribution will appear.
 Press the [Cancel] button to return to the analysis result
screen.

Revised January 2017

8-6 Sysmex XP-300


Display and Output of Analysis Results

(3) Press the [] button to select the discriminator you want to
change from a list at the bottom left of the screen.
The selected discriminator is highlighted.
(4) Press the [] or [] button to move the discriminator position
on the histogram.
The discriminator position relocated is displayed in the list at
the bottom left of the screen.
The range within which each discriminator position can move is
shown below.
Manual discrimination screen
(WBC)
 Manual discrimination screen (WBC)
Discri. to move Lower limit Upper limit
LD 6fL (0ch) T1
T1 LD T2
T2 T1 UD
UD T2 300fL (49ch)

WBC particle distribution covers 50 channels of 0 to 49 (6 fL


per channel), and the channel changes by one at a time.
Manual discrimination screen The relation between WBC particle distribution channel and fL
(RBC) display is as follows:
Discri. position (fL) = (Channel No. + 1) × 6

 Manual discrimination screen (RBC)


Discri. to move Lower limit Upper limit
LD 5fL (0ch) UD
UD LD 250fL (49ch)

RBC particle distribution covers 50 channels of 0 to 49 (5 fL


per channel), and the channel changes by one at a time.
Manual discrimination screen
(PLT)
The relation between RBC particle distribution channel and fL
display is as follows:
Discri. position (fL) = (Channel No. + 1) × 5

 Manual discrimination screen (PLT)


Discri. to move Lower limit Upper limit
LD 1fL (0ch) UD
UD LD 40fL (39ch)

PLT particle distribution covers 40 channels of 0 to 39 (1 fL per


channel), and the channel changes by one at a time.
The relation between PLT particle distribution channel and fL
display is as follows:
Revised January 2017

Discri. position (fL) = (Channel No. + 1) × 1

Sysmex XP-300 8-7


Display and Output of Analysis Results

(5) After moving the discriminator, press the [Recalc.] button.


The discriminator position is set and analysis data is
re-calculated on the basis of new discriminator position.
Re-calculated data is reverse-displayed on the screen.
* Pressing the [Cancel] button will display the manual
discrimination quit confirmation dialog.
 Pressing the [OK] button on the manual discrimination
quit confirmation screen returns to the analysis result
screen without changing the settings.
 Pressing the [Cancel] button on the manual discrimination
quit confirmation screen returns to the manual
discrimination screen, and allows manual discrimination
operation.

Note:
Pressing the [Top] button on the analysis result screen also
displays the manual discrimination quit confirmation
dialog. In this case, pressing the [OK] button in the dialog
returns to the Main screen without changing the settings.

(6) Press the [Set] button.


The setting change confirmation dialog will appear.
 Press the [OK] button to update the changed contents and
return to the analysis result screen.
 Press the [Cancel] button to return to the manual
discrimination screen.

Analysis values changed in manual discrimination are reverse-


displayed on the analysis result screen.
Revised January 2017

8-8 Sysmex XP-300


Display and Output of Analysis Results

Editing the sample ID

The ID numbers of the latest samples displayed on the analysis result


screen can be edited.
(1) Press the [ID Edit] button on the analysis result screen.
The sample ID edit screen will appear.

(2) Press the [Sample ID] display column.


The ID number of the latest sample is reverse-displayed and the
numeric keyboard is displayed.
(3) Change the sample ID.
During the sample ID input, the most right character can be
deleted by pressing the [C] button.

(4) Press the [Ent.] button.


The numeric keypad closes and the ID edit confirmation dialog
will appear.
 Press the [Set] button to define the sample ID and close the
dialog.
 Pressing the [Cancel] button closes the dialog without
changing the sample ID.
Revised January 2017

Sysmex XP-300 8-9


Display and Output of Analysis Results

Output of analysis result (latest sample)

The analysis data displayed on the analysis result screen can be


printed by the internal/external printer, or output to the host
computer.
(1) Display the analysis data you want to print on the analysis result
screen, and press the [Out/Del] button.
The output/delete menu dialog will appear.

(2) Select the output destination button from the internal printer
(IP), graphic printer (GP), list printer (LP) or host computer
(HC).
 [Current]: Prints/outputs the analysis result.
 [Cancel]: Closes the output/delete menu dialog.

Note:
• The output/delete menu dialog buttons are valid only for
output destination buttons set in [Host Output] and
[Printer] in the Settings menu.
• When outputting to the host computer, it is possible to
output to either the serial port (RS-232C) or LAN
(Ethernet), depending on the user setting.
• User settings can also be made for automatic output.
(See “Host Output” and “Printer” in “11.2 Possible
settings”.)

Revised January 2017

8-10 Sysmex XP-300


Display and Output of Analysis Results

8.2 Stored data


This instrument can store the analysis results of up to 40,000
samples. Data is preserved, even after the instrument is switched
OFF, and can be called anytime as long as it is not deleted.

Information
If the number of samples that can be stored in
memory is exceeded and a new analysis is
performed, the oldest data is deleted (first in, first out).
Data stored in memory includes QC analysis results.

Executing the stored data processing program

(1) Press the [Menu] button on the Main screen.


The Menu screen will appear.

(2) Press the [Str. Data] button.


The stored data screen (first screen [1/4]) is displayed and the
cursor appears on the latest sample.

Note:
• In the stored data screen, the data can be displayed in the
order of analysis date.
• When the stored data screen is displayed, the cursor appears
on the sample most recently viewed.
• If the [Str. Data] button is pressed when no stored data are
present, a dialog to the effect that no data are available is
displayed instead of the list screen.
Revised January 2017

Sysmex XP-300 8-11


Display and Output of Analysis Results

To return to the Main screen, press the [Top] button on the stored
data screen.
Sample ID and analysis mode on the Main screen will return to the
settings before executing the stored data processing program.

Stored data screen

Press the [Str. Data] button on the Menu screen to display the stored data screen.
The stored data screen is composed of list screens (first to fourth) and detail screens (first to fourth). Screens
can be switched by pressing the [] button and are displayed in the order as shown below.

First list screen Second list screen Third list screen Fourth list screen

Fourth detail screen Third detail screen Second detail screen First detail screen

Revised January 2017

8-12 Sysmex XP-300


Display and Output of Analysis Results

First list screen

Displays the sample ID, sample ID attribute, analysis mode, date and time of analysis and instrument error
flag in the stored data.

Analysis mode Date and time of


analysis
Sample ID attribute

Memory No.
Instrument error flag

Not-output mark

Sample ID

Cursor sample

Histogram error flag or


numeric value abnormal flag

Second list screen

Displays the sample ID, analysis mode and operator ID in the stored data.

Analysis mode

Sample ID Operator ID

Cursor sample

Histogram error flag or


numeric value abnormal flag
Revised January 2017

Sysmex XP-300 8-13


Display and Output of Analysis Results

Third list screen

Displays the analysis results of WBC, RBC, and HGB.

Analysis mode

Sample ID Analysis data

Cursor sample

Histogram error flag or


numeric value abnormal flag

Fourth list screen

Displays the analysis data of HCT and PLT.

Analysis mode

Sample ID Analysis data

Cursor sample

Histogram error flag or


numeric value abnormal flag
Revised January 2017

8-14 Sysmex XP-300


Display and Output of Analysis Results

Display items in list screens

[Out/Del]: Prints or deletes the stored analysis data. For details, see “Output of
stored data” and “Deleting stored data” in “8.2 Stored data”.
[Search]: Searches for the stored analysis data. For details, see “Searching
stored data” in “8.2 Stored data”.
[Graph]: Displays the first detail screen of the selected sample data.
[]: Moves to the previous analysis result.
However, when the oldest analysis result is selected, this button
operation becomes invalid.
[]: Moves to the next analysis result.
However, when the latest analysis result is selected, this button
operation becomes invalid.
[]: Switches the screen in such an order as first to fourth (list) and first to
fourth (detail). For details, see “Stored data screen” in “8.2 Stored
data”.
Sample ID: Displays the sample ID number.
Histogram error flag or numeric value abnormal flag:
When a flag is added to the analysis result, the column next to the
sample ID is displayed in red or yellow.
The following flags are shown depending on the color.
Color Flag
Red Out of the linearity limit flag [!]
Numeric value abnormal flag (low reliability data flag [], out
of the patient limit flags [+] and [-])
Yellow Histogram error flag ([WL], [WU], etc.)
* For details about histogram error flags, see “8.3 Histogram
error flags”.

Analysis mode: Displays the analysis mode for the sample.


Displays [WB] for the whole blood mode, [PD] for the pre-diluted
mode and [QC] for the quality control mode.
Date and time of analysis: Displays the date and time when the analysis result was obtained.
Sample ID attribute: Indicates the sample ID attribute with one of the following symbols.
[M]: Number manually entered from the numerical keys dialog
[A] : Number automatically assigned during analysis
[B] : Number read out by a bar code reader
Cursor sample: The data at the cursor is displayed in the highlighted manner (white
letters in blue background).
Memory No.: Displays the memory number of the data at the cursor position.
Operator ID: Displays the operator ID of the analysis.
Analysis data: Displays the analysis data of WBC, RBC, HGB, HCT and PLT.
Instrument error flag: Appears when an instrument malfunction is detected during analysis.
Revised January 2017

Sysmex XP-300 8-15


Display and Output of Analysis Results

Not-output mark: Displays whether or not the analysis data has been printed from the
internal/graphic printer or output to the host computer.
[I] : The data has not been printed from the internal printer. The mark
disappears when printed.
[G] : The data has not been printed from the graphic printer. The mark
disappears when printed.
[H] : The data has not been output to the host computer. The mark
disappears when output.

Detail screen

Analysis results of the selected sample are displayed on the detail screen.
The detail screen is composed of 4 screens (first to fourth), each of which displays analysis results of the
following parameters:

First detail screen WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT
Second detail screen WBC, LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#
Third detail screen RBC, MCV, RDW-SD, RDW-CV, PLT, PDW, MPV, P-LCR, PCT
Fourth detail screen WBC research parameters (ResearchW, ResearchS, ResearchM, ResearchL)

Analysis mode

Sample ID Date and time of analysis


Operator ID
Instrument error flag

Histogram Analysis data

Example: Second detail screen

Description of the detail screens

[Out/Del]: Prints or deletes the stored analysis data. For details, see “Output of
stored data” and “Deleting stored data” in “8.2 Stored data”.
[Search]: Searches for the stored analysis data. For details, see “Searching stored
data” in “8.2 Stored data”.
[List]: Displays the first list screen. The cursor is located at the sample data that
is currently displayed.
Revised January 2017

[]: Moves to the previous analysis result.


However, when the oldest analysis result is displayed, this button
operation becomes invalid.

8-16 Sysmex XP-300


Display and Output of Analysis Results

[]: Moves to the next analysis result.


However, when the latest analysis result is displayed, this button
operation becomes invalid.
[]: Switches the screen in such an order as first to fourth (detail) and first to
fourth (list). For details, see “Stored data screen” in “8.2 Stored data”.
Analysis mode: Displays the analysis mode for the sample. Displays [WB] for the whole
blood mode, [PD] for the pre-diluted mode and [QC] for the quality
control mode.
Sample ID: Displays the sample ID number.
Instrument error flag: Appears when an instrument malfunction is detected during analysis.
Histogram: Displays the histograms of WBC, RBC and PLT on the second to fourth
detail screens.
Date and time of analysis: Displays the date and time when the analysis result was obtained.
Operator ID: Displays the operator ID of the analysis.
Analysis data: Displays the analysis data of each parameter. When an analysis error
occurs, a histogram error flag or abnormal data flag is displayed.

Searching stored data

On the stored data screen, data can be searched for using the sample
ID and the date of analysis as the search key.
(1) Press the [Search] button on the stored data screen.
The search dialog will appear.

(2) Select the search key.


[Sample ID]: Select this option when data is
searched using the sample ID.
A numeric keypad will appear.
Date [Year] [Month] [Day]: Select this option when data is
searched using the date of
analysis. A numeric keypad for
date input is displayed.

Note:
• When the numeric keypad is displayed in the search dialog,
boxes in which you can input are reverse-displayed.
• A bar code can also be input while displaying the numeric
Revised January 2017

keypad.
• The search dialog is displayed with the date on that day in
the Date [Year], [Month] and [Day] display columns.

Sysmex XP-300 8-17


Display and Output of Analysis Results

(3) Enter a sample ID or date using the keypad and press the
[Search] button.

Note:
Searching cannot be carried out when only space is entered.

 Press the [Cancel] button to cancel the search and close the
dialog.
All analysis results are displayed on the search result screen and
the cursor moves to the latest analysis data among those that
fulfill the search condition.
Press the [Graph], [], [] or [] buttons to select data and
switch the screens. (For details, see “Stored data screen” in
“8.2 Stored data”.)
To conduct an additional search, press the [Search] button.
Press the [Back] button to close the search result screen and
return to the stored data screen.

Press the [Out/Del] button on the search result screen to display


the output/delete menu dialog. Search results can be printed or
deleted using the dialog.
Select the output destination from the internal printer (IP),
graphic printer (GP), list printer (LP) or host computer (HC).
 [Current]: Prints/outputs/deletes the analysis result at the
cursor position.
 [All]: Prints/outputs/deletes all search results.
However, the number of search results printed or
output at a time is limited as follows.
IP: Max. 200
GP: Max. 2,000
LP: Max. 2,000
HC: Max. 2,000
 [Cancel]: Closes the output/delete menu dialog.

Note:
• The output/delete menu dialog buttons are valid only for
output destination buttons set in [Host Output] and
[Printer] options in the Settings menu.
• When outputting to the host computer, it is possible to
output to either the serial port (RS-232C) or LAN
(Ethernet), depending on the user setting.
• User settings can also be made for automatic output.
Revised January 2017

(See “Host Output” and “Printer” in “11.2 Possible


settings”.)

8-18 Sysmex XP-300


Display and Output of Analysis Results

Output of stored data

The analysis data displayed on the stored data screen can be printed
by the internal/external printer, or output to the host computer.
(1) Select the data you want to output on the list screen of the stored
data screen or display the data you want to output on the detail
screen, then press the [Out/Del] button.
The output/delete menu dialog is displayed.

(2) Select the output destination button from the internal printer
(IP), graphic printer (GP), list printer (LP) or host computer
(HC).
 [Current]: Prints/outputs the analysis result.
 [Cancel]: Closes the output/delete menu dialog.

Note:
• The output/delete menu dialog buttons are valid only for
output destination buttons set in [Host Output] and
[Printer] options in the Settings menu.
• When outputting to the host computer, it is possible to
output to either the serial port (RS-232C) or LAN
(Ethernet), depending on the user setting.
• User settings can also be made for automatic output.
(See “Host Output” and “Printer” in “11.2 Possible
settings”.)
Revised January 2017

Sysmex XP-300 8-19


Display and Output of Analysis Results

Deleting stored data

You can delete analysis data displayed on the stored data screen.
(1) Select the data you want to delete on the list screen of the stored
data screen or display the data you want to delete on the detail
screen, then press the [Out/Del] button.
The output/delete menu dialog is displayed.

(2) Press the [Current] button next to “Delete”.


The deletion confirmation dialog will appear.
 Pressing the [OK] button deletes the analysis data selected
or displayed.
 Pressing the [Cancel] button in the output/delete dialog/
deletion confirmation dialog cancels the deletion and returns
to the previous screen.

Revised January 2017

8-20 Sysmex XP-300


Display and Output of Analysis Results

8.3 Histogram error flags


Various information can be obtained from the histograms. The
XP-300 extracts the characteristics of the histogram and displays
them as histogram flags. (For details about histogram error flags, see
“Analysis of histogram” in “14. Technical Information”.)
When the histogram flags are displayed, perform analysis again. If
afterwards the flags are still displayed, the sample is considered to
correspond to one of the following.
Flag Probable sample cause Correction (reference)
[WL] Incomplete lysing of red blood cells, presence of 1) Centrifuge sample and replace the plasma with
nucleated red blood cells, increase of large equal volume of saline or CELLPACK and
platelets, platelet aggregation or agglutination, repeat analysis.
precipitation of fibrin, etc. 2) Check smear, etc.
[RL] Presence of fragmented red blood cells, increase 1) Manual red blood cell count of sample
of large platelets, platelet aggregation or 2) Check smear, etc.
agglutination, etc.
[PL] Effects of cryoglobulins, fragmented red blood 1) Warm sample at 37°C for 30 minutes and
cells, or cellular fragments of white blood cells, repeat analysis.
etc. 2) Check smear, etc.
[WU] Incomplete lysing of red blood cells, presence of 1) Centrifuge sample and replace the plasma with
immature white blood cells, white blood cell equal volume of saline or CELLPACK and
aggregation, platelet satellite phenomenon, etc. repeat analysis.
2) Check smear, etc.
[RU] Effects of cold agglutinin, inclusion of white 1) Warm sample at 37°C for 30 minutes and
blood cells, etc. repeat analysis.
2) Check smear, etc.
[PU] Increase of large platelets, inclusion of 1) Manual platelet count of sample
fragmented red blood cells, precipitation of 2) Check smear, etc.
cryoglobulins, etc.
[DW] Significant anisocytosis, etc. 1) Check smear, etc.
(RBC)
[DW] Inclusion of fragmented red blood cells, non- 1) Check smear, etc.
(PLT) uniformity in size of platelets, effects of 2) Centrifuge sample and replace the plasma with
cryoglobulins. equal volume of saline or CELLPACK and
repeat analysis, warm sample at 37°C for
30 minutes and repeat analysis, etc.
[MP] Effects of anemia treatment or blood transfusion 1) Check smear, etc.
(RBC) causing the presence of cells of multiple sizes.
[MP] Platelet aggregation, sample with low values for 1) Check smear, etc.
(PLT) platelets.
[T1] Presence of CML or other immature granulocytes, 1) Check smear, etc.
incomplete lysing of red blood cells, etc. 2) Centrifuge sample and replace the plasma with
equal volume of saline or CELLPACK and
repeat analysis, warm sample at 37°C for
30 minutes and repeat analysis, etc.
Revised January 2017

Sysmex XP-300 8-21


Display and Output of Analysis Results

Flag Probable sample cause Correction (reference)


[T2] Presence of CML or other immature granulocytes, 1) Check smear, etc.
incomplete lysing of red blood cells, aged sample, 2) Centrifuge sample and replace the plasma with
etc. equal volume of saline or CELLPACK and
repeat analysis, warm sample at 37°C for
30 minutes and repeat analysis, etc.
[F1], [F2], Presence of CML or other immature granulocytes, 1) Check smear, etc.
[F3] sample with high values for monocytes, 2) Centrifuge sample and replace the plasma with
eosinophils, and basophils, incomplete lysing of equal volume of saline or CELLPACK and
red blood cells, aged sample, etc. repeat analysis, warm sample at 37°C for
30 minutes and repeat analysis, etc.
[AG] Presence of nucleated red blood cells, effects of 1) Check smear, etc.
fragmented red blood cells, increase of large
platelets, platelet aggregation or agglutination,
precipitation of fibrin, etc.

Revised January 2017

8-22 Sysmex XP-300


Quality Control

9. Quality Control
The reliability of this instrument and reagents is monitored by quality
control. By use of control blood or control materials the stability of
the measured value is monitored over a certain period of time, and
problems can be detected early or prevented.
A quality control should be performed:
 Before analyzing samples
 After replacement of the reagent
 After maintenance
 If there is any doubt about the accuracy of the analysis values
 As required by regulation(s)

Control blood is analyzed in whole blood mode for quality controls.

9.1 Control material


The control materials, EIGHTCHECK-3WP-N(Normal),
EIGHTCHECK-3WP-L(Low level) and EIGHTCHECK-3WP-
H(High level) are used. These are equivalent to Low, Normal and
High level.

Information
• Do not use any other control material than
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H. This control blood is
specially developed for the analyzer’s measuring
technology.
• When opening a new lot, the previously entered
assay values and lot numbers must be erased.

Product name

EIGHTCHECK-3WP-N 1.5 mL × 12 vials


4.6 mL × 12 vials
EIGHTCHECK-3WP-L 1.5 mL × 12 vials
4.6 mL × 12 vials
EIGHTCHECK-3WP-H 1.5 mL × 12 vials
4.6 mL × 12 vials

Intended purpose
Revised January 2017

Control blood material is used to test the precision and accuracy of


automated and semi-automatic hematology analyzers. Do not use
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H for the calibration of the system.

Sysmex XP-300 9-1


Quality Control

Warning and precautions

Do not inject or ingest.


The human blood used for the production of EIGHTCHECK-3WP-
N, EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H has been
tested with licensed reagents (Food and Drugs Administration’s
Bureau of Biologic, USA) and has been found non-reactive for
Hepatitis B Surface Antigen, Hepatitis C Virus (HCV) and HIV
(HIV1+HIV2) Antibody. However, none of the test methods known
today can guarantee that products based on human blood are not
infectious. In keeping with good laboratory practice, this product
should be considered potentially capable of transmitting infectious
disease.

Composition

EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and


EIGHTCHECK-3WP-H contain stabilized human erythrocytes,
fixed human white blood cells and a platelet component in a medium
containing preservatives.

Storage and shelf life after first opening

EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and


EIGHTCHECK-3WP-H are to be stored at 2-8ºC before and after
opening.
When handled in this manner, the unopened product is guaranteed
stable until the expiration date stated on the package.
After opening, the product is stable for 7 days if returned to the
refrigerator promptly after use.
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H have been tested and found to provide
stable parameter values after at least 12 hours at room temperature
(25ºC).

Additional special equipment

EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and


EIGHTCHECK-3WP-H are intended to be used with SYSMEX
reagents and analyzers only.
Refer to the instrument manual for further information.

Note:
If other control materials are used the product performance
of Sysmex instruments cannot be guaranteed.
Revised January 2017

9-2 Sysmex XP-300


Quality Control

Procedure

Preparing control blood


(1) Remove a vial of control material from the refrigerator and
equilibrate to room temperature (18-30ºC) for 15 minutes before
use.
(2) Place the vial between the palms and roll it back and forth 10
times (see illustration).
(3) Turn the vial upside down and roll 10 more times.
(4) Repeat steps (2) and (3) 8 times or for a total of 2 minutes.
Examine the bottom of the vial and assure thoroughly mixing
by confirming that there is no pellet of cells adhering to the
bottom of the vial before performing the analysis. If there still is
pellet of cells, repeat step (3).
(5) Analyze the control blood sample in the same manner as patient
whole blood, according to procedures listed in the instrument’s
Instructions for Use. Wipe threads of cap and vial with clean
lint-free tissue before replacing cap. Recap vial tightly.
(6) Store at 2-8ºC in an upright position.

Note:
Always check with current control materials insert
instructions.

Manual procedures
Reference method can be applied to EIGHTCHECK-3WP-N,
EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H. Refer to a
manual for clinical laboratory procedures.

Methodology

Principle of the method


EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H are to be used as hematology control bloods
for the quality control of any Sysmex fully automated and semi-
automated hematology analyzers. EIGHTCHECK-3WP-N is for the
normal level, EIGHTCHECK-3WP-L is for the low abnormal level
and EIGHTCHECK-3WP-H is for the high abnormal level.
The WBC histogram of EIGHTCHECK-3WP-N, EIGHTCHECK-
3WP-L and EIGHTCHECK-3WP-H indicate 3 part distributions
when the instrument’s particle distribution analysis is used.
The use of stabilized cell preparation for controlling hematology
instrumentation is an established procedure. When handled like a
patient sample measured in QC mode and assayed on a properly
Revised January 2017

calibrated (HGB, HCT) and functioning instrument,


EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H will provide values within the expected
range indicated on the assay sheet.

Sysmex XP-300 9-3


Quality Control

Performance characteristics and limitations of the method


A manual differential analysis of white blood cells cannot be
accomplished with EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-
L and EIGHTCHECK-3WP-H.
The PRP (platelet rich plasma) method to assay the platelet count
cannot be accomplished with EIGHTCHECK-3WP-N,
EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H.

Traceability of control materials

The mean assay values (range) of EIGHTCHECK-3WP-N,


EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H are derived
from replicate analyses on whole blood calibrated instruments using
the reagents recommended by the equipment manufacturer.
The measuring results for EIGHTCHECK-3WP-N, EIGHTCHECK-
3WP-L and EIGHTCHECK-3WP-H should be within the relevant
expected range.
The expected ranges listed represent estimates of inter-laboratory
variation, which is usually accounted for by instrument calibration,
maintenance and operating technique.
For this reason, the assay values given are guidelines only used for
the control of the measuring system and are not absolute assays for
calibration.

Disposal

Expired EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and


EIGHTCHECK-3WP-H should not be disposed in general waste.
Disposal procedures should meet the requirements of all applicable
local regulations.

References

 Henry, J.B. Clinical Diagnostic and Management by Laboratory


Methods. Ed.17. W.B. Saunders.
Philadelphia, PA 1984.
 Wintrobe, M.M. ‘Clinical Hematology’, 8th Edition, Lea and
Febiger, Philadelphia, 1981.
 Department of Labor, Occupational Safety and Health
Administration. 29 CFR PART 1910. 1030: Occupational
Exposure to Bloodborne Pathogens: Final Rule.
Revised January 2017

9-4 Sysmex XP-300


Quality Control

9.2 Control methods


This instrument has following 2 quality control methods. Choose the
control method in accordance to your laboratory’s internal
regulations.

X control

The X control uses control blood (EIGHTCHECK-3WP) to monitor


an instrument’s performance over time.
In X control, control blood is subjected to 2 consecutive analyses and
the mean of them is used as the QC data. Therefore the imprecision
of the analysis has only a small impact on the QC data.

Levey-Jennings (L-J) control

Unlike the X control that is subjected to 2 consecutive analyses and


the mean of them is used as the QC data, the L-J control uses the data
from a single analysis of control blood as QC data.
Therefore the imprecision of the analysis has a stronger impact on
the QC data than with the X control method so that the control
thresholds are wider (or: have a higher range) compared to the
X control method. An instrument’s performance over time can be
monitored by conducting the L-J control 2 or more times during daily
operation.
Revised January 2017

Sysmex XP-300 9-5


Quality Control

9.3 Quality control process flow


Set when the instrument is
Select quality control method.
purchased and as needed.

Set when a new lot of the


Set control blood information
control blood is used.

Perform quality control analysis.

Perform daily.

Check and record quality control


results (QC chart screen).

Information
A total of 6 quality control files can be stored. Each file
can contain data of up to 22 parameters by 60 points.

Revised January 2017

9-6 Sysmex XP-300


Quality Control

9.4 Control method selection


If the power is OFF, turn the main power switch ON and wait until
the status display shows [Ready].
Follow the procedures below to switch the control method.
(1) Press the [Menu] button on the Main screen.
The Menu screen will appear.

(2) Press the [Settings] button.


The Settings menu screen will appear.

Note:
If a password has been set, the password input screen will
appear. Enter the password.

(3) Press the [Quality Control] button.


A current control method will be displayed on the quality
control setting screen.
Revised January 2017

Sysmex XP-300 9-7


Quality Control

(4) Select the control method.


 [X]: X control
 [L-J]: L-J control
(5) Select a data output method.
This setting allows automatic output of results when quality
control analysis is completed.
 [Disable]: No output.
 [IP]: Print on internal printer.
 [GP]: Print on graphic printer.
 [HC]: Output to host computer.
 [IP+HC]: Print on internal printer and output to host
computer.
 [GP+HC]: Print on graphic printer and output to host
computer.

Information
When outputting to the host computer, the instrument
outputs to the serial port (RS-232C) or LAN
(Ethernet), depending on the connection settings for
host computer. (See “11. Instrument Setup”.)

(6) Press the [Save] button.


The save confirmation dialog appears.
 Press the [OK] button to update quality control settings and
return to the Main screen.
 Press the [Cancel] button to close the dialog.
* In the quality control setting storing confirmation dialog,
pressing the [Top] button will display the quit confirmation
dialog. Press the [OK] button to return to the Main screen
without changing the settings. Press the [Cancel] button to
close the dialog to continue the settings.
Revised January 2017

9-8 Sysmex XP-300


Quality Control

9.5 Settings for control blood information (QC files)


Before using new control blood, input the control blood information
into the instrument.
Contents of these settings are the control blood lot ID, expiration
date, TARGET value and LIMIT values for each control parameter.
These can be entered by the following 2 methods.
 Entering from numerical keys dialog
 Entering from handheld bar code reader
Quality control determines the 2 aspects of the instrument status. The
analysis results fall within or out of the range of TARGET±LIMIT
determines the accuracy and the changes in analysis results over
times determine the precision. TARGET±LIMIT values are referred
to as the control limit values. TARGET value and LIMIT values are
different for each lot of the control blood.
The instrument automatically determines accuracy from the
TARGET value and LIMIT values that were input into the
instrument beforehand.
With this instrument, the TARGET and LIMIT values can also be
automatically calculated.
In a QC file, you can confirm and print the chart showing changes in
the analysis results over time as shown below.

+ LIMIT

TARGET

- LIMIT

This instrument stores the control blood information in 6 locations


(QC files).
Revised January 2017

Sysmex XP-300 9-9


Quality Control

Entering from numerical keys dialog

(1) Press the [QC] button at the Ready status.


The analysis control file selection screen will appear.

(2) Press the display column of the file number to be used.


The quality control analysis starting screen for the selected file
will appear.

Note:
QC file settings can be made using file display columns 1 - 6.
If settings are made in a display column that has a registered
QC file, the existing file will be overwritten.

(3) Press the [Settings] button.


The first QC file setting screen will appear.
When the display column for the parameter to be set is pressed,
the numerical keys will be displayed, and the setting value can
be input.

Note:
Pressing the [Setup] button on the QC chart screen also
displays the first QC file setting screen. For further
information regarding the displays, see “9.7 Quality control
chart screen”.

(4) Press the [Lot ID] column.


The alphanumeric input dialog will appear.
(5) Input the lot ID.
Up to 10 digits can be input for the lot ID.
(6) Press the [Expiration] column.
The date input dialog will appear.
(7) Input the expiration date.
Up to 10 digits can be input for the expiration date.

Note:
Revised January 2017

• The analyzer does not judge the expiration dates entered in


the QC file.
• Only [yyyy/mm/dd] is available for the expiration date
input format.

9-10 Sysmex XP-300


Quality Control

(8) Press the [] button.


When the [] button is pressed, the display changes from the
first QC file setting screen to the second screen. After the sixth
screen, pressing the [] button returns to the first screen. When
the [] button is pressed, the display changes in the reverse
order.

Note:
The QC file setting screens are consisted of 6 screens.

(9) Press each of the parameter display columns.


The numeric input dialog will appear.
(10) Input the TARGET value and the LIMIT value for each
parameter.

Information
There are 22 control parameters, and since not all of
these can be displayed on one screen, switch the LCD
screen by using the [] or [] button.

Note:
When 2 or more plots are present in the base QC data, the
TARGET value and LIMIT value can be calculated
automatically. For details, see “Automatic settings of the
TARGET value and LIMIT value” in “9.5 Settings for
control blood information (QC files)”.
Revised January 2017

Sysmex XP-300 9-11


Quality Control

(11) When the setting is completed, press the [Save] button.


The quality control setting storing confirmation dialog will
appear.
 Press the [OK] button to store the setting value, and either
the X first analysis start screen or the L-J analysis starting
screen will appear.
 Press the [Cancel] button to close the dialog.
* In the quality control setting storing confirmation dialog,
pressing the [Top] button will display the quit confirmation
dialog. Press the [OK] button to return to the Main screen
without changing the settings. Press the [Cancel] button to
close the dialog to continue the settings.

Note:
• To clear all of the set information, press the [Clear] button
on the first QC file setting screen.
The deletion confirmation of quality control setting
message will be displayed.
 Press the [OK] button to return the control data to
default and to close the dialog.
 Press the [Cancel] button to cancel control data
deletion and return to the previous screen.
• Pressing the [IP] button on the first QC file setting screen
prints out the current file’s lot ID, expiration date,
TARGET value and LIMIT width of each parameter in the
quality control printing format.

Revised January 2017

9-12 Sysmex XP-300


Quality Control

Entering from handheld bar code reader

(1) Press the [QC] button at the Ready status.


The analysis control file selection screen will appear.

(2) Press the display column of the file number to be used.


The quality control analysis starting screen for the selected file
will appear.

Note:
QC file settings can be made using file display columns 1 -
6.
If settings are made in a display column that has a
registered QC file, the existing file will be overwritten.

(3) Press the [Settings] button.


The first QC file setting screen will appear.

Note:
Pressing the [Setup] button on the QC chart screen also
displays the first QC file setting screen. For further
information regarding the displays, see “9.7 Quality control
chart screen”.

(4) Read the Lot ID bar code in the Assay Sheet.


The Lot ID will be displayed if correctly read. When the
displayed Lot ID is not correct, read the bar code again.
(5) Read the expiration date bar code in the same way.
(6) Press the [] button.
When the [] button is pressed, the display changes from the
first QC file setting screen to the second screen. Pressing the
[] button on the sixth screen returns to the first screen. When
the [] button is pressed, the display changes in the reverse
order.

Note:
The QC file setting screens are consisted of 6 screens.
Revised January 2017

Sysmex XP-300 9-13


Quality Control

(7) Read each of the bar code in the Assay Sheet in the same way as
(4).

Note:
• In each parameter, bar code has the information of
TARGET value and LIMIT value.
Only the item that appears in the display can be input.
When all parameters are input in the screen, switch the
screen by using the [] button to continue input.
• When 2 or more plots are present in the base QC data, the
TARGET value and LIMIT value can be calculated
automatically. For details, see “Automatic settings of the
TARGET value and LIMIT value” in “9.5 Settings for
control blood information (QC files)”.

(8) When the setting is completed, press the [Save] button.


The quality control setting storing confirmation dialog will
appear.
 Press the [OK] button to store the setting value, and either
the X first analysis start screen or the L-J analysis starting
screen will appear.
 Press the [Cancel] button to close the dialog.
* In the quality control setting storing confirmation dialog,
pressing the [Top] button will display the quit confirmation
dialog. Press the [OK] button to return to the Main screen
without changing the settings. Press the [Cancel] button to
close the dialog to continue the settings.

Note:
• To clear all of the set information, press the [Clear] button
on the first QC file setting screen.
The deletion confirmation of quality control setting
message will be displayed.
 Press the [OK] button to return the control data to
default and to close the dialog.
 Press the [Cancel] button to cancel control data
deletion and return to the previous screen.
• Pressing the [IP] button on the first QC file setting screen
prints out the current file’s lot ID, expiration date,
TARGET value and LIMIT width of each parameter in the
quality control printing format.
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9-14 Sysmex XP-300


Quality Control

Automatic settings of the TARGET value and LIMIT value

When setting control blood information, the TARGET value and


LIMIT value that are set on the second through sixth QC file setting
screens can be automatically calculated and set if 2 or more plots are
present in the base QC data.

Note:
For setting methods of control blood information including
TARGET and LIMIT values, see “Entering from numerical
keys dialog” or “Entering from handheld bar code reader”
in “9.5 Settings for control blood information (QC files)”.

(1) Press the [A.Tgt] button on the QC file setting screens (second
to sixth).
A TARGET value is automatically calculated.
If 2 or more plots present: The automatic target confirmation
dialog will appear. Press the
[Execute] button. The average of all
plots is automatically calculated and
displayed on the button in the
[TARGET] column.
If 1 or no plot presents: A dialog to the effect that no
calculation is possible is displayed.
(2) Press the [A.Lmt] button.
A LIMIT value is automatically calculated.
If 2 or more plots present: The automatic limit selection dialog
will appear. Select a LIMIT width
from [2SD] and [3SD].
2SD or 3SD of all plots is
automatically calculated, and
displayed on the button in the
[LIMIT] column.
If 1 or no plot presents: A dialog to the effect that no
calculation is possible is displayed.
Revised January 2017

Sysmex XP-300 9-15


Quality Control

9.6 Performing a quality control

Risk of Infection
Wear protective garments and gloves when you
analyze the control blood. After completion of work,
wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can
occur.

(1) Press the [QC] button on the Main screen.


The analysis control file selection screen will appear.

(2) Press the display column of the analyzing file.


The analysis starting screen will appear.

Information
Before performing analysis, it is necessary to select a
control method and enter the control blood
information.
(See “9.4 Control method selection” and “9.5 Settings
for control blood information (QC files)”.)

Note:
Pressing the [IP Print] button on the analysis starting
screen prints out the current file’s lot ID, expiration date,
TARGET value and LIMIT width of each parameter in the
quality control printing format.
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9-16 Sysmex XP-300


Quality Control

X control

(1) Be sure the status display indicates [Ready] for quality control
analysis.

Note:
QC analysis is always performed in the whole blood mode.
When the analysis mode is set in the pre-diluted mode, the
mode changeover sequence is activated to switch to the
whole blood mode.

(2) Mix control blood by rotating and inverting 10 times each for 2
minutes.

Caution!
The control blood (EIGHTCHECK-3WP) remains
usable for the specified period of days in the package
insert. If it is used after this point, abnormal count
values may result.

(3) Remove the cap while taking care not to allow blood to scatter.

(4) Set the control blood container to the sample probe and press
Start switch
the start switch in that status.
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Sysmex XP-300 9-17


Quality Control

The Analyzing screen will appear.


After completion of a single analysis, the results are displayed on the
LCD screen.

Caution!
• When analysis starts, the status reads [Aspirating].
When sample aspiration is completed, the status
display [Aspirating] changes to [Running]. When
[Running] is displayed, the control blood container
can be removed safely.
Do not remove the control blood container from the
sample probe while [Aspirating] is displayed.
Otherwise, there is a possibility that proper aspiration
cannot be performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the control blood container
by that time.
• To remove the container, lower it straight down. Take
care not to bend the sample probe.

Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.

After completion of the first analysis, these analysis results will be


displayed in the [X1] column on the analysis result screen.
Use the [] or [] button to scroll the screen pages.
 Press the [IP] button to print the results from the first analysis.

Information
The print format is used for quality control analysis
only and cannot be changed.

 Press the [OK] button to accept data from the first analysis and
perform the second analysis. If the analysis results are not to be
accepted, you can perform a new analysis by pressing the [NG]
button. In either case, remove the control blood, close the cap,
and mix well.
Then, remove the cap again, set the control blood to the sample
probe, and press the start switch of the instrument.
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9-18 Sysmex XP-300


Quality Control

* When the [Top] button is pressed, the quality control analysis


confirmation message “Quit QC Analysis?” will be displayed.
Press the [OK] button to discard the analysis results and return
to the Main screen.
Press the [Cancel] button to return to the previous screen.

When the second analysis is completed, the analysis results from this
analysis will be displayed in the [X2] column on the analysis result
screen. The mean values of the analysis results from the first and the
second analyses will be displayed in the [X] column. Use the [] or
[] button to scroll the screen pages.
 Press the [IP] button to print the second analysis results and the
mean of the first and the second analysis results.
* When the [Top] button is pressed, the “Quit QC Analysis?”
message will be displayed.
Press the [OK] button to discard the analysis results and return
to the Main screen.
Press the [Cancel] button to return to the previous screen.
 Press the [OK] button to accept the results of the two analyses,
and output the mean of the two analyses to the internal printer
or host computer, depending on the quality control data output
settings. If the results of the second analysis are not to be
adopted, press the [NG] button to perform a new second
analysis. When performing re-analysis, remove the control
blood, close the cap, and mix well. Then, remove the cap again,
set the control blood to the sample probe, and press the start
switch of the instrument.

Note:
The analysis results are saved to the stored data.

Example: Sample IDs when quality control analysis was performed


with file No. 3 will be shown as the following:
X1 analysis results: QC03-1
X2 analysis results: QC03-2
Mean of X1 and X2: QC03 (The mean does not contain
histogram data.)
From the stored data screen for output, the result data can be
printed out or transferred to the host computer.
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Sysmex XP-300 9-19


Quality Control

For parameters with a mean of the two analyses that is beyond the
control limit and if the value is above the higher limit, + is
displayed in the [Judgment] column, and if the values are below the
lower limit, – is displayed. Then an alarm sounds and the QC error
message is displayed.
Press the button and the action message will appear.

Press the [Back] button to turn off the alarm.

Information
For details about actions to resolve the QC (X) error,
see “QC(X-bar) Error” in “13. Troubleshooting”.

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9-20 Sysmex XP-300


Quality Control

L-J control

(1) Be sure the status display indicates [Ready] for quality control
analysis.

Note:
QC analysis is always performed in the whole blood mode.
When the analysis mode is set in the pre-diluted mode, the
mode changeover sequence is activated to switch to the
whole blood mode.

(2) Mix control blood by rotating and inverting 10 times each for 2
minutes.

Caution!
The control blood (EIGHTCHECK-3WP) remains
usable for the specified period of days in the package
insert. If it is used after this point, abnormal count
values may result.

(3) Remove the cap while taking care not to allow blood to scatter.

(4) Set the control blood container to the sample probe and press
Start switch
the start switch in that status.
Revised January 2017

Sysmex XP-300 9-21


Quality Control

The Analyzing screen will appear.


After completion of a single analysis, the results are displayed on the
LCD screen.

Caution!
• When analysis starts, the status reads [Aspirating].
When sample aspiration is completed, the status
display [Aspirating] changes to [Running]. When
[Running] is displayed, the control blood container
can be removed safely.
Do not remove the control blood container from the
sample probe while [Aspirating] is displayed.
Otherwise, there is a possibility that proper aspiration
cannot be performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the control blood container
by that time.
• To remove the container, lower it straight down. Take
care not to bend the sample probe.

Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.

The analysis results are displayed in the [Data] column and these
results are compared with the control limit and displayed in the
[Judgment] column on the analysis result screen.
Use the [] or [] button to scroll the screen pages.
 To print results on the internal printer, press the [IP] button.

Information
The print format is used for quality control analysis
only and cannot be changed.
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9-22 Sysmex XP-300


Quality Control

* When the [Top] button is pressed before defining the quality


control data, the quality control analysis confirmation message
“Quit QC Analysis?” will be displayed.
Press the [OK] button to discard all analysis results, complete
the quality control program and return to the Main screen.
Press the [Cancel] button to return to the analysis starting
screen and continue the quality control analysis.
 Press the [OK] button to accept the analysis results, and output
the results to the internal printer or host computer, depending on
the quality control data output settings. If the results of the
analysis are not to be accepted, press the [NG] button to
perform a new analysis.
When performing re-analysis, remove the control blood, close
the cap, and mix well. Then, remove the cap again, set the
control blood to the sample probe, and press the start switch of
the instrument.

Note:
The analysis results are saved to the stored data.

Example: Sample IDs when quality control analysis was


performed with file No. 3 will be shown as the
following:
Analysis results: QC03
From the stored data screen for output, the result data
can be printed out or transferred to the host computer.
For parameters whose values are beyond the control limit, and if the
values are above the upper limit, + is displayed in the [Judgment]
column, and if the values are below the lower limit, – is displayed.
Then an alarm sounds and the QC error message is displayed.
Press the button and the action message will appear.

Press the [Back] button to turn off the alarm.

Information
For details about actions to resolve the QC (L-J) error,
see “QC(L-J) Error” in “13. Troubleshooting”.
Revised January 2017

Sysmex XP-300 9-23


Quality Control

9.7 Quality control chart screen


A total of 6 quality control files are available. Each file can contain
data of up to 22 parameters by 60 points.
The content of quality control files can be confirmed on the quality
control chart screen.

Starting up quality control chart screen


(1) Press the [Menu] button on the Main screen.
The Menu screen will appear.

(2) Press the [QC Chart] button.


The quality control chart screen (1/11) will appear.

Note:
When the quality control chart screen is displayed, the
screen for the sample most recently viewed or updated
appears.

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9-24 Sysmex XP-300


Quality Control

Quality control chart screen

The quality control chart screen is consisted of 11 screens, each of which displays data of the following
parameters:
With the default settings, the first quality control chart screen is displayed first.

First quality control chart screen WBC, RBC Seventh quality control chart screen MXD#, NEUT#

Second quality control chart screen HGB, HCT Eighth quality control chart screen W-SMV, W-LMV

Third quality control chart screen MCV, MCH Ninth quality control chart screen RDW-SD, RDW-CV

Fourth quality control chart screen MCHC, PLT Tenth quality control chart screen PDW, MPV

Fifth quality control chart screen LYM%, MXD% Eleventh quality control chart screen P-LCR, PCT

Sixth quality control chart screen NEUT%, LYM#

Lot ID
File Expiration date

Date and time of


analysis

Item

Chart

Operator ID
Revised January 2017

Sysmex XP-300 9-25


Quality Control

Display items in quality control chart screens

[Out/Del]: Prints or deletes the quality control data. For details, see “Printing control
chart”, “External output” and “Deleting data” in “9.7 Quality control
chart screen”.
[]: Changes the screens in the following order; “First chart screen” 
“Eleventh chart screen”  ...  “Second chart screen”  “First chart
screen”.
[]: Changes the screens in the following order; “First chart screen” 
“Second chart screen”  ...  “Eleventh chart screen”  “First chart
screen”.
[]: Moves the control chart cursor (vertical line) to the previous plot and
updates the data and date/time accordingly. When the cursor is located at
the left end of the chart, the button is not operative.
[]: Moves the control chart cursor (vertical line) to the next plot and updates
the data and date/time accordingly. When the cursor is located at the right
end of the chart or on the latest plot, the button is not operative.
[QC File]: Displays the quality control file
selection screen.
Press the display column of each
file to display the corresponding
quality control chart screen.

[Setup]: Displays the first quality control file setting screen of the file that is
currently displayed.
Lot ID: Displays the lot ID number.
Expiration date: Display the expiration date.
Date and time of analysis: Displays the analysis date/time for the selected data.
Item: Displays the analysis parameters.
Chart: Displays up to 60 points of quality control data.
If the number of data is less than 60, all data are displayed in order from
the left end.
If the operator calls up another parameter by using the [] or [] button,
the same range of the data are displayed for that parameter.
Operator ID: Displays the operator ID of the analysis.
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9-26 Sysmex XP-300


Quality Control

Printing control chart


(1) Press the [Out/Del] button in the quality control chart screen.
The output/delete menu dialog will appear.

(2) Select the output destination button from the internal printer
(IP), graphic printer (GP) or list printer (LP).
 [Current]: Prints out the data at the cursor position in the
control quality printing format.
 [Chart]: Prints out control charts of all parameters.
 [All]: Prints out all plot data of the file being displayed
(up to 60 plots).
 [Cancel]: Closes the output/delete menu dialog.

Note:
• The output/delete menu dialog buttons are valid only for
output destination buttons set in [Printer] in the Settings
menu.
• User settings can also be made for automatic output.
(See “Printer” in “11.2 Possible settings”.)
• While this dialog appears on the LCD, other buttons outside
the dialog are not operative.

External output
(1) Press the [Out/Del] button in the quality control chart screen.
The output/delete menu dialog will appear.
(2) Press the [Current] button next to “HC”.
The data at the cursor position is output to the host computer in
the quality control output format. It is possible to output to
either the serial port (RS-232C) or LAN (Ethernet), depending
on the user setting.

Note:
• User settings can also be made for automatic output.
(See “Host Output” in “11.2 Possible settings”.)
• When no setting is made to output to the host computer, the
Revised January 2017

[Current] button next to “HC” becomes invalid.

Sysmex XP-300 9-27


Quality Control

Deleting data

(1) Press the [Out/Del] button in the quality control chart screen.
The output/delete menu dialog will appear.
(2) Press the [Current] button next to “Delete”.
A dialog confirming the deletion of the current control data will
appear.
 Press the [OK] button to delete the data at the cursor
position in the quality control chart and close the dialog.
 Press the [Cancel] button to cancel control data deletion and
return to the previous screen.

Revised January 2017

9-28 Sysmex XP-300


Calibration

10. Calibration
Calibration is performed to compensate for any inaccuracies of the
pneumatic, hydraulic, and electric systems which will affect analysis
results. This is very important in maintaining the system accuracy.
Calibration is carried out by entering calibration values into the
instrument.
Your Sysmex service representative will perform initial calibration
of your unit at installation. After installation, the operator should
make periodical calibration and proper quality control to maintain
the accuracy.
This chapter describes the calibration procedure.

Caution!
Calibration verification needs to be performed in
specified intervals, but when quality control data
varies with time, HGB and HCT should be calibrated.
When abnormal quality control data occur as a result
of instrument problem, reagent degradation, or
deterioration of control blood, however, do not perform
calibration.
Revised January 2017

Sysmex XP-300 10-1


Calibration

10.1 Calibration flow chart

HGB/HCT calibration start

Analyze samples by the reference method to determine


reference value (target value).
Automatic calibration: 5 samples
Manual calibration: Over 5 samples
Page 10-3

Automatic Manual
calibration calibration

Select automatic calibration


Page 10-4 Calculate calibration value.
mode and parameter.
• Calculate a mean of reference values.
• Perform analysis (* in whole blood mode).
• Calculate a mean of analysis values.
Enter target value. Page 10-6 • Calculate calibration value.
Page 10-9

Perform analysis
Page 10-7
(* in whole blood mode).
Update calibration value.
• Select manual calibration mode.
• Enter calibration value.
Update calibration value. Page 10-8 Page 10-10

Completion of HGB/HCT calibration


Revised January 2017

10-2 Sysmex XP-300


Calibration

10.2 Samples used for calibration


For calibration, use 5 or more samples of fresh normal blood meeting
the following conditions:
 Blood from healthy person who is not taking any medication
 Blood added with an appropriate amount of anticoagulant
 Per-sample whole blood volume to exceed 2 mL
 HGB value to exceed 10.0 g/dL
 HCT value to be within 35.5% and 55.5%

Information
For calibration, do not use EIGHTCHECK-3WP.
EIGHTCHECK-3WP was not prepared for calibration
but for the use as control blood.

10.3 Establishing reference values


5 or more normal blood samples prepared for calibration of HGB and
HCT should be accurately analyzed 3 times each in accordance with
the following reference methods. The measurements thus obtained
are used as reference values.
HGB values: Cyanmethemoglobin method
HCT values: Microhematocrit method
(5 samples are used for automatic calibration.)
Revised January 2017

Sysmex XP-300 10-3


Calibration

10.4 Automatic calibration


In automatic calibration, 5 or more fresh, normal blood samples are
used for automatic calibration of HGB and HCT values.

Selecting automatic calibration mode and parameters

(1) Press the [Menu] button at the Ready status.


The Menu screen will appear.

(2) Press the [Calib.] button.


The calibrating menu screen will appear.

Note:
If a password has been set, the password input screen will
appear. Enter the password.

Revised January 2017

10-4 Sysmex XP-300


Calibration

(3) Press the [Auto Calib.] button.


The automatic calibration target value setting screen will
appear.
Revised January 2017

Sysmex XP-300 10-5


Calibration

Entering target values

(1) Enter the reference values determined into the Target column.
When the button for the Target is pressed, the numerical keys
dialog will be displayed.
After entering a target value, press the [Ent.] button. The
entered value will be defined.

Information
Set “0” for the parameter that is not being calibrated.

(2) After completion of entering target values, press the [Next]


button.
The automatic calibration target value confirmation message
will be displayed.

 Press the [OK] button to define target values, and display


the automatic calibration analysis starting screen.
 Press the [Cancel] button to close the dialog, and the setting
can be continued.
* Press the [Top] button to display the setting cancel
confirmation dialog.
Press the [OK] button to return to the Main screen without
changing any setting, and the [Cancel] button to close the
dialog and then to continue the setting.

Revised January 2017

10-6 Sysmex XP-300


Calibration

Performing analysis

When all target values have been entered, the instrument is ready for
analysis.

Information
Automatic calibration is always performed in the whole
blood mode. When the analysis mode is set in the
pre-diluted mode, the instrument will automatically
switch to the whole blood mode.

Set the sample to the sample position, and press the start switch to
start analysis.
The automatic calibration analyzing screen will appear.

Caution!
• Analyze the samples used for determining the
reference value. The values of the sample to be
analyzed are indicated by the underline cursor.
• When analysis starts, the status reads [Aspirating].
When sample aspiration is completed, the status
display [Aspirating] changes to [Running]. When
[Running] is displayed, the sample can be removed
safely.
Do not remove the sample tube from the sample
probe while [Aspirating] is displayed. Otherwise,
there is a possibility that proper aspiration cannot be
performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the sample tube by that
time.
• To remove the sample tube, lower it straight down.
Take care not to bend the sample probe.

Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.
Revised January 2017

Sysmex XP-300 10-7


Calibration

When an analysis is performed, its values are listed in the Data


column and calculated calibration values in the Calib. (%) column,
then the underline cursor moves to the next sample. When the
analysis of more than one sample is completed, the calibration value
is calculated automatically for each analysis, and it is displayed at the
bottom of the Calib. (%) column.
The mean calibration value for each analysis and the current
calibration value are used to calculate and display the new calibration
value.

Information
During analysis, if the mean calibration value for each
analysis exceeds 105% or is less than 95%, or if the
new calibration value exceeds 120% or is less than
80%, an alarm sounds and the automatic calibration
error confirmation dialog will appear.
Press the [Cancel] button, and analyze again.
The calibration ratio can be calculated using the
following formula.
New calibration
value
Calibration Ratio = × 100
Current calibration
value

Perform analysis for 5 samples.

Updating calibration values


After completion of all analysis, press the [Quit] button. The
automatic calibration complete confirmation dialog will appear.
The calibration value change confirmation message will appear.
 Press the [OK] button to update the calibration values, and to
return to the Main screen.
 Press the [Cancel] button to return to the Main screen without
updating the calibration values.
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10-8 Sysmex XP-300


Calibration

10.5 Manual calibration


In manual calibration, calculated calibration value can be entered
using the numeric keys.

Information
Use normal and fresh blood of 5 or more samples.

Calculating the calibration value


(1) Establish the reference values as described in
“10.3 Establishing reference values”.
(2) Calculate the mean value.
(3) Analyze the samples in whole blood mode. (See “7.8 Analysis
in whole blood (WB) mode”.)
(4) Calculate the mean value.
(5) Calculate the calibration value using the following formula.

Average of values analyzed


New calibration value = by reference method
Previous calibration value ×
Average of values analyzed
by this instrument
Example:
Average of HGB values gained by the reference method = 14.0 g/dL
Average of HGB values gained by this instrument = 14.2 g/dL
Previous calibration value of HGB = 98.7%

14.0
98.7 × = 97.30 97.3
14.2
Therefore, the new calibration value of HGB needs to be set at
97.3%.
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Sysmex XP-300 10-9


Calibration

Updating calibration values

(1) Press the [Menu] button at the Ready status.


The Menu screen will appear.

(2) Press the [Calib.] button.


The calibrating menu screen will appear.

Note:
If a password has been set, the password input screen will
appear. Enter the password.

(3) Press the [Manual Calib.] button.


The manual calibration setting screen will appear.

(4) Press the calibration value display column for the calibrated
parameter.
The numerical keys dialog will be displayed.
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10-10 Sysmex XP-300


Calibration

(5) Enter the calibration value.


 Enter the value, and press the [Ent.] button.
The entered value will be defined.

Note:
If nothing is input (space), the calibration value cannot be
defined.

 After completion of entering the calibration values, press the


[Quit] button.
The manual calibration setting confirmation dialog will be
displayed.

Information
An alarm sounds and the manual calibration error
confirmation dialog is displayed, if the mean
calibration value for each analysis exceeds 105% or is
less than 95%, or if the new calibration value exceeds
120% or is less than 80%.
The calibration ratio can be calculated using the
following formula.
New calibration
value
Calibration Ratio = × 100
Current calibration
value

 Press the [OK] button to update the calibration values, and


to return to the Main screen.
 Press the [Cancel] button to return to the Main screen
without updating the calibration values.
Revised January 2017

Sysmex XP-300 10-11


Calibration

10.6 Printing calibration history


An overview of 5 most recent calibration histories can be printed out
on the internal printer.
(1) Press the [Menu] button at the Ready status.
The Menu screen will appear.

(2) Press the [Calib.] button.


The calibrating menu screen will appear.

Note:
If a password has been set, the password input screen will
appear. Enter the password.

(3) Press the [Print Cal. His.] button.


The internal printer will print the calibration history.
Revised January 2017

10-12 Sysmex XP-300


Instrument Setup

11. Instrument Setup


By changing individual settings, you can adapt the instrument to
your needs or existing laboratory conditions.

Note:
Upon initial operation, some settings need to be updated.
Example: Current date and time

11.1 Introduction
(1) Press the [Menu] button at the Ready status.
The Menu screen will appear.

(2) Press the [Settings] button.


The Settings menu screen will appear.

Note:
If a password has been set, the password input screen will
appear. Enter the password.

(3) Select the button to be changed from the Settings menu.


The screen for the selected parameter will appear.
When the [] and [] buttons are displayed on the bottom of
the screen, the setting contents are divided into 2 or more pages.
Pages can be switched by pressing the [] or [] button.
Revised January 2017

Sysmex XP-300 11-1


Instrument Setup

(4) Change the setting, and press the [Save] button.


The setting storing confirmation dialog screen will appear.
 Press the [OK] button to update the changed settings and to
return to the Main screen.
 Press the [Cancel] button to close the dialog, and the setting
can be continued.
* Press the [Top] button to display the setting cancel
confirmation dialog.
Press the [OK] button to return to the Main screen without
changing any setting, and the [Cancel] button to close the
dialog and then to continue the setting.

Revised January 2017

11-2 Sysmex XP-300


Instrument Setup

11.2 Possible settings

Note:
The underlined items are the initial settings made before
shipment from the factory.

System
Make the basic settings for the instrument.
Parameter Setting
[Units] [Type 1]/[Type 2]/[Type 3]/[Type 4]/[Type 5]/
[Type 6]
[Type 1]: Japan
[Type 2]: General Export
[Type 3]: Canada SI
[Type 4]: Dutch SI
[Type 5]: Standard SI
[Type 6]: Hong Kong SI
Setting changes made for this parameter become
valid the next time the main power switch is
turned ON. For details, see “14. Technical
Information”.
[Language] [Japanese]/[English]/[French]/[German]/
[Spanish]/[Italian]/[Chinese]/[Russian]/
[Portuguese]/[Indonesian]/[Korean]/
[PT-BR]*1
Setting changes made for this parameter become
valid the next time the main power switch is
turned ON.
*1: Brazilian Portuguese
[Par.Name] [W-SCR]/[LYM%]
Setting changes made for this parameter become
valid the next time the main power switch is
turned ON.
[Volume] [1]/[2]/[3]
[1]: Quiet
[2]: Medium
[3]: Loud
[Alarm] [Type 1]/[Type 2]/[Type 3]/[Type 4]/[Type 5]/
[Type 6]
[Type 1]: High continuous beep
[Type 2]: Repeated high beeps
Revised January 2017

[Type 3]: Repeated high 2-tone beeps


[Type 4]: Low continuous beep
[Type 5]: Repeated low beeps
[Type 6]: Repeated low two-tone beeps

Sysmex XP-300 11-3


Instrument Setup

Parameter Setting
[ISBT128] [Enable]/[Disable]
When [Enable] is selected, the ISBT128 bar
code will be loaded as a sample ID number with
up to 13 characters.
[ID Inc.] [Enable]/[Disable]
When [Enable] is selected, the sample ID
number is automatically incremented.

Information
It is not possible to convert the stored data between
Dutch SI units and other units for the following 3
parameters: HGB, MCH and MCHC.
Do not use the stored sample data which was stored
before the setting change. In addition, renew settings
for patient limits, and for quality control TARGET and
LIMIT values.

Date/Time

The calendar and clock of the instrument can be set here.

Note:
• When time changes to summer or winter time, respectively,
the clock must be manually corrected accordingly.
• Numeric input exceeding the upper limit is replaced with
the upper limit value in each parameter.

Parameter Setting
[Format] [yyyy/mm/dd]/[mm/dd/yyyy]/[dd/mm/yyyy]
[Year] Numeric input: 2000 - 2037
[Month] Numeric input: 1 - 12
[Day] Numeric input: 1 - 28/29/30/31
Determine the available numeric input range by
the Year and Month settings.
[Hour] Numeric input: 0 - 23
[Minute] Numeric input: 0 - 59
Revised January 2017

11-4 Sysmex XP-300


Instrument Setup

Patient Limits

The upper and lower mark limits for the patient results can be entered
here. If the analysis result exceeds the Upper Limit (UL), a [+] flag is
added next to that parameter. If the result is below the Lower Limit
(LL), a [-] flag is added. (See the table below for the initial settings.)

Parameter LL (Lower UL (Upper Unit


Limit) Limit)
WBC 3.0 15.0 × 103/µL
RBC 2.50 5.50 × 106/µL
HGB 8.0 17.0 g/dL
HCT 26.0 50.0 %
MCV 86.0 110.0 fL
MCH 26.0 38.0 pg/dL
MCHC 31.0 37.0 g/dL
PLT 50 400 × 103/µL
RDW-SD 37.0 54.0 fL
RDW-CV 11.0 16.0 %
LYM% (W-SCR) 5.0 55.0 %
MXD% (W-MCR) 1.0 20.0 %
NEUT% (W-LCR) 45.0 95.0 %
LYM# (W-SCC) 0.0 0.0 × 103/µL
MXD# (W-MCC) 0.0 0.0 × 103/µL
NEUT# (W-LCC) 0.0 0.0 × 103/µL
MPV 9.0 13.0 fL
PDW 9.0 17.0 fL
P-LCR 13.0 43.0 %
PCT 0.17 0.35 %

Note:
If LL or UL that satify the following conditions was entered
in the Patient Limit setting screen, a beep sounds and the
entering is canceled.
• LL is higher than UL.
• UL is lower than LL.
Revised January 2017

Sysmex XP-300 11-5


Instrument Setup

Quality Control

Here the QC method and the data output method can be selected.
Parameter Selection
[QC Method] [X]/[L-J]
[Data Out.] [Disable]/[IP]/[GP]/[HC]/[IP+HC]/
[GP+HC]

Product ID

If several XP-300 analyzers are connected to the host computer, a


unique naming can be set to identify each instrument so that the
unique naming is transmitted to the host computer along with the
analysis result.
Parameter Setting
[Product ID] Alphanumeric input: Up to 15 digits of
alphanumeric character

Host Output
The method of data output to the host computer can be set here.
Parameter Setting
[Connect] [Disable]/[Serial]/[LAN]
[Auto Out.] [Enable]/[Disable]
[Format] [XP]/[pocH]/[KX-21N]/[ASTM]/
[K-1000]/[K-DPS]
[T. Rate] [1200 bps]/[2400 bps]/[4800 bps]/
[9600 bps]/[19200 bps]
[Data Len.] [7 bits]/[8 bits]
[Stop bit] [1 bit]/[2 bits]
[Parity] [Even]/[Odd]/[Disable]
[Protocol] [Class A]/[Class B]
[T. Interv.] [0 s]/[2 s]/[3 s]/[5 s]/[7 s]/[10 s]/[15 s]
[RTS/CTS] [Enable]/[Disable]
[ID Pad.] [0 Pad.]/[SpacePad.]
[RDW] [RDW-SD]/[RDW-CV]
[ASTM Rev.] [1381-95]/[1381-02]

Note:
Revised January 2017

The [RDW] setting is only available when [K-1000] is


selected in [Format]. Data will be output in both
parameters, RDW-SD and RDW-CV, for any other options
in [Format].

11-6 Sysmex XP-300


Instrument Setup

Printer

The method of printing out analysis results can be set here. The print
header can be set as desired, using information such as the laboratory
name or instrument name. See “14.3 Print formats”.
For entering numerals, see “Numerical keys dialog” in “6.1 Screen
display”.

Parameter Setting
[Header]*1 Alphanumeric input: Up to 16 digits of
First to third lines alphanumeric
characters for
each line
[Int.Print]*2
[IP Auto Pri.] [All Data]/[Error Data]/[Disable]
[Format] [Type 1]/[Type 2]/[Type 3]
[Type 1]: Prints 20 analysis results and
the histograms.
[Type 2]: Prints 20 analysis results.
[Type 3]: Prints only CBC8 analysis
results.
[Ext.Print]*3
[Connect] [Enable]/[Disable]
[Type] [ESC/P]/[PCL5]/[Bitmap (for PC)]
[GP AutoPri.] [All Data]/[Error Data]/[Disable]
[Bitmap (for PC)]*4
[IP Address] Numeric input:
0 - 255 (common to all columns)
Default: “0.0.0.0”
[Port Number] Numeric input: 0 - 9999
Default: “0”
*1: Common parameters to the internal/external printer
*2: Parameters for the internal printer
*3: Parameters for the external printer
*4: Only available when [Bitmap (for PC)] is selected in [Type].
Revised January 2017

Sysmex XP-300 11-7


Instrument Setup

Network

Address and other necessary settings can be made here for use of
LAN (Ethernet) port to communicate host computer. In addition, the
MAC address can be checked at this screen. For details, consult
network administrator at your laboratory.
 Client

Parameter Setting
[IP Address] Numeric input:
0 - 255 (common to all columns)
Default: “192.168.0.100”
[Network Mask] Numeric input:
0 - 255 (common to all columns)
Default: “255.255.255.0”
[Default Gateway] Numeric input:
0 - 255 (common to all columns)
Default: “0.0.0.0”

 Host
Parameter Setting
[IP Address] Numeric input:
0 - 255 (common to all columns)
Default: “192.168.0.20”
[Port Number] Numeric input: 0 - 9999
Default: “5006”

Note:
Numeric input exceeding the upper limit is replaced with
the upper limit value in any parameters other than [Port
Number]. Revised January 2017

11-8 Sysmex XP-300


Instrument Setup

11.3 Password setting


To prevent unauthorized change of the important settings of the
instrument, a password may be activated. The following functions
are password-protected:
 Calibration functions
 Setting functions
When any of the above functions is selected, you will be prompted
with the password entry screen. Key in the password and confirm
with the [Ent.] button.

Information
In case the password has been forgotten, contact your
local Sysmex service representative.

Password setting procedure

(1) Press the [Menu] button on the Main screen.


The Menu screen will appear.

(2) Press the [Settings] button.


The Settings menu screen will appear.

Note:
If a password has been set, the password input screen will
appear. Enter the password.
Revised January 2017

Sysmex XP-300 11-9


Instrument Setup

(3) Press the [Password Setting] button.


The password setting screen will appear.

(4) Press the New Password column.


The alphanumeric input dialog will appear. Set the password by
using maximum 10 digits of numerals (0-9) or hyphens (-).
Then press the [Ent.] button.
(5) Press the Retype Password column.
Enter the new password to be set again, and then press the
[Ent.] button.
(6) Press the [Save] button.

Information
If the New Password and the Retype Password are
not identical, the password setting error message will
appear. Re-enter the password into both boxes.

When the New Password and the Retype Password are


identical, the store setting data confirmation message will be
displayed.
 Press the [OK] button to update the changed settings and to
return to the Main screen.
 Press the [Cancel] button to cancel the setting changes, and
close dialog.
* Press the [Top] button on the setting screen. The setting stop
confirmation dialog will appear.
Press the [OK] button to return to the Main screen without
changing the settings. Press the [Cancel] button to close the
dialog and continue the setting.
Revised January 2017

11-10 Sysmex XP-300


Instrument Setup

11.4 Print settings


All the set values can be printed on the internal/external (graphic
only) printer.
(1) Press the [Menu] button on the Main screen.
The Menu screen will appear.

(2) Press the [Settings] button.


The Settings menu screen will appear.

Note:
If a password has been set, the password input screen will
appear. Enter the password.

(3) Press the [Print Settings] button.


The print set value dialog will appear.

(4) Press the desired output destination button.


 [IP]: Prints the set values on the internal printer.
 [GP]: Prints the set values on the graphic printer.
* Press the [Top] button to close the print set value dialog.
Revised January 2017

Sysmex XP-300 11-11


Instrument Setup

Revised January 2017

11-12 Sysmex XP-300


Cleaning and Maintenance

12. Cleaning and Maintenance


To ensure proper functioning of the instrument, it is necessary to
periodically clean and service the instrument. Perform maintenance
according to the schedule below. And record the results in the
Maintenance checklist.

Risk of Infection
To avoid the risk of infections, wear protective
garments and gloves for all cleaning or maintenance
work. After completion of work, wash hands with
disinfectant. Otherwise, there is a risk of infection by
pathogens.

12.1 Maintenance schedule

Daily

 Clean TD chambers and diluted sample lines (Shutdown)


(see 12.3)
 Check trap chamber level and discard (see 12.4)

Weekly

 Clean SRV tray (see 12.5)

Every month (or every 1,500 samples)

 Clean TD (see 12.6)


 Clean waste chamber (see 12.7)

Every 3 months (or every 4,500 samples)

 Clean SRV (see 12.8)

As-needed maintenance

 Check instrument status (see 12.2)


 Perform Auto Rinse (see 12.9)
 Clean rinse cup (see 12.10)
 Dispose waste fluid (see 12.11)
 Clean aperture of TD chamber (see 12.12)

Revised January 2017

Calibrate LCD screen (see 12.13)


 Reset SRV cycle counter (see 12.14)
 Adjust pressure and vacuum (see 12.15)

Sysmex XP-300 12-1


Cleaning and Maintenance

12.2 Check instrument status


If you should contact the Sysmex service representative regarding
any instrument problem, you may be asked to check the operation
counter, program version, and other information.
(1) Press the [Menu] button at the Ready status.
The Menu screen will appear.

(2) Press the [Maint.] button.


The maintenance menu screen will appear.

(3) Press the [Status Display] button.


The status display screen will appear. The following
information is displayed on this LCD screen.
* The status display screen consists of 2 screens. Press the []
or [] button to switch the screen.
 [Pressure]: Current pressure value
 [Vacuum]: Current vacuum value
 [HGB Convert]: HGB convert value
 [Sensor]: ON/OFF status of each sensor
 [SV]: ON/OFF status of each solenoid valve
 [Version]: Program version
 [Total C.]: Number of cycles since instrument
production
 [SRV C.]: Number of cycles since last cleaning of
the SRV
 [Waste C.]: Number of cycles since last cleaning of
waste chamber
 [DetectorC.]: Number of cycles since last cleaning of
TD
Revised January 2017

12-2 Sysmex XP-300


Cleaning and Maintenance

12.3 Clean TD chambers and diluted sample lines (Shutdown)


Executing a Shutdown cleans TD chambers and diluted sample lines.
Therefore, the TD chambers and diluted sample lines must be
cleaned at the end of the day’s analysis. Run the Shutdown when a
day’s analysis is completed. Perform this procedure at least once
every 24 hours if the instrument is on continuously.

Caution!
If the Shutdown sequence is not performed, protein
may build up inside the instrument. This can cause
incorrect analysis results or damage the instrument.

Note:
• If 24 hours have passed and Shutdown has not been
performed, a message appears prompting the operator to
perform Shutdown.
• It takes approx. 5 minutes to complete the Shutdown
sequence.

(1) Press the [Shutdown] button at the Ready status.


The Shutdown confirmation message will appear.
In case the [Cancel] button is pressed, the Shutdown is
canceled, and the instrument returns to the Main screen.
Revised January 2017

Sysmex XP-300 12-3


Cleaning and Maintenance

Start switch (2) Set CELLCLEAN to the sample probe, and in that condition,
press the start switch.
While [Aspirating] is being displayed on the screen, keep
holding CELLCLEAN in the same status, as long as the “beep”
is present.

Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water. Otherwise, it can damage the
skin or clothes.

Note:
Once the Shutdown sequence is started, it cannot be
canceled anymore.

Caution!
• When analysis starts, the status reads [Aspirating].
When the status display [Aspirating] changes to
[Running], the CELLCLEAN container can be
removed safely.
Do not remove the CELLCLEAN container from the
sample probe while [Aspirating] is displayed.
Otherwise, there is a possibility that proper aspiration
cannot be performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the CELLCLEAN
container by that time.
• To remove the CELLCLEAN container, lower it straight
down. Take care not to bend the sample probe.

(3) Check that the Shutdown completion screen appears.


Turn OFF the main power switch on the right side of the
instrument.
Revised January 2017

12-4 Sysmex XP-300


Cleaning and Maintenance

12.4 Check trap chamber level and discard


After completion of analyses for the day, check trap chamber level
and discard any liquid that has collected.
(1) Turn off the power and wait approximately 30 seconds.
Trap chamber Float (2) Turn the chamber on the left side of the unit counterclockwise
and remove.
(3) After discarding the liquid, mount the chamber. Make sure the
Loosen
float is inside.

Risk of Infection
When discarding the trap chamber liquid, always wear
rubber gloves. After completion of work, wash hands
with disinfectant. If your hands are contaminated by
the blood, etc., infection of bacteria can occur.

Caution!
• If liquid collects everyday, the hydraulic system may
have failed. Contact your Sysmex technical
representative.
• Pay attention to the direction of the float in the
chamber. Place it with its pointed end facing upward.
Revised January 2017

Sysmex XP-300 12-5


Cleaning and Maintenance

12.5 Clean SRV tray


Clean the SRV tray once a week in the following procedure:

Risk of Infection
When cleaning the SRV tray, always wear rubber
gloves. After completion of work, wash hands with
disinfectant. If your hands are contaminated by blood,
etc., infection of bacteria can occur.

(1) Turn off the power of the main unit and wait approximately 30
seconds.
(2) Open the front cover of the main unit.
(3) Remove the SRV tray.

Caution!
When removing the SRV tray, take care not to loosen
Probe fixing the probe fixing screw. If analysis is made with the
screw
screw loosened, air can enter the system and affect
SRV tray the data.

(4) Wash the SRV tray using tap water.


(5) Make sure no contaminants remain, then wipe off water.
SRV tray
(6) Re-mount the SRV tray to the original state.

Caution!
After mounting the SRV tray, make sure the probe
fixing screw is not loose. If analysis is made with the
screw loosened, air can enter the system and affect
the data.

Information
Mount the SRV tray properly as to the face/bottom
and the direction.

(7) Close the front cover of the main unit.


Revised January 2017

12-6 Sysmex XP-300


Cleaning and Maintenance

12.6 Clean TD
When the main power switch is turned ON, and if either the counter
value exceeds 1,500, or if 1 month has passed since the last
maintenance, a message will appear prompting the operator to
perform periodic maintenance (TD cleaning).
 Press the [Cancel] button to continue start up without executing
the cleaning TD operation. Until the TD is cleaned, the message
is displayed at start-up.
 When this message is displayed, perform the TD cleaning
according to the following procedures.

Note:
Even when the above-mentioned message is not displayed,
TD cleaning can be executed by pressing the [Maint.]
button of the menu screen, then pressing the [Clean
Transducer] button of the maintenance screen.

(1) Open the front cover of the main unit.


(2) Open the transducer cover.

Note:
The transducer cover with spring close hinge automatically
closes when you let go of the cover.

Filler
(3) Using the filler provided with the unit, pour approximately 1
mL each of CELLCLEAN into the WBC transducer and RBC
transducer.

Risk of Infection
When opening the transducer cover, wear protective
garments and gloves. After completion of work, wash
hands with disinfectant. If your hands are
contaminated by blood, etc., there is a risk of infection
by pathogens.
Revised January 2017

Sysmex XP-300 12-7


Cleaning and Maintenance

Warning!
• Do not press the start switch while pouring
CELLCLEAN into the TD chamber. Otherwise, there
is a risk of electric shock.
• CELLCLEAN is a strong alkaline cleaning solution.
Do not mix it with any acidic substances. Also, it
should not come in contact with skin or clothing. If
the skin or clothes should come in touch with it, flush
it away using plenty of water. Otherwise, it can
damage the skin or clothes.

Caution!
Do not pour more than 1 mL of detergent
(CELLCLEAN) into the chamber. It may overflow,
possibly causing electric shocks or leakage.

Information
Take care not to have detergent (CELLCLEAN)
adhere to the chamber side wall.

(4) Close the transducer cover.


(5) Close the front cover of the main unit.
(6) Press the start switch.
Cleaning TD will be executed, and the cleaning TD screen will
appear.
Then, Auto Rinse and background check will be performed.

Note:
When executing the TD cleaning from the maintenance
menu screen, the TD cleaning starting screen will be
displayed after the preprocessing sequence is executed.
Then press the start switch.

After completion of TD cleaning, the Main screen will appear.

Information
When the cleaning is performed, the detector counter
(number of cycles since last cleaning of TD) is
automatically reset.
Revised January 2017

12-8 Sysmex XP-300


Cleaning and Maintenance

12.7 Clean waste chamber


When the main power switch is turned ON, and if either the counter
value exceeds 1,500, or if 1 month has passed since the last
maintenance, a message will appear prompting the operator to
perform periodic maintenance (waste chamber cleaning).
 Press the [Cancel] button to continue start up without executing
waste chamber cleaning operation. Until the waste chamber is
cleaned, the message is displayed at start-up.
 When this message is displayed, perform the waste chamber
cleaning as shown in the following procedures.

Note:
Even when the above-mentioned message is not displayed,
waste chamber cleaning can be executed by pressing the
[Maint.] button of the menu screen, then pressing the
[Clean W. Chamber] button of the maintenance screen.

Start switch (1) Set CELLCLEAN to the sample probe, and in that condition,
press the start switch.
While [Aspirating] is being displayed on the screen, keep
holding CELLCLEAN in the same status, as long as the “beep”
is present.

Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water to avoid injury or damage.
Otherwise, it can damage the skin or clothes.
Revised January 2017

Sysmex XP-300 12-9


Cleaning and Maintenance

Caution!
• When analysis starts, the status reads [Aspirating].
When the status display [Aspirating] changes to
[Running], the CELLCLEAN container can be
removed safely.
Do not remove the CELLCLEAN container from the
sample probe while [Aspirating] is displayed.
Otherwise, there is a possibility that proper aspiration
cannot be performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the CELLCLEAN
container by that time.
• To remove the CELLCLEAN container, lower it
straight down. Take care not to bend the sample
probe.

Cleaning waste chamber will be executed, and the cleaning


waste chamber screen will appear.
Then, Auto Rinse and background check will be performed.

(2) After completion of waste chamber cleaning, the Main screen


will appear.

Information
When the cleaning is performed, the detector counter
(number of cycles since last cleaning of waste
chamber) is automatically reset.
Revised January 2017

12-10 Sysmex XP-300


Cleaning and Maintenance

12.8 Clean SRV


When the main power switch is turned ON, and if either the counter
value exceeds 4,500, or if 3 months have passed since the last
maintenance, a message will appear prompting the operator to
perform periodic maintenance (SRV cleaning).
 Press the [Cancel] button to continue start up without executing
SRV cleaning operation. Until the SRV is cleaned, the above
message is displayed at start up.
 When this message is displayed, perform the SRV cleaning
according to the following procedures.

(1) Press the [OK] button.


The SRV counter is reset, and the main power switch can be
turned OFF.

Risk of Infection
When cleaning the SRV, always wear rubber gloves.
After completion of work, wash hands with
disinfectant.
If your hands are contaminated by blood, etc.,
infection of bacteria can occur.

Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water.
Otherwise, it can damage the skin or clothes.

Caution!
Before turning the power off, always press the [OK]
button, making the instrument ready to be turned off.

Note:
When cleaning the SRV before the above message is
displayed, reset the SRV counter (see “12.14 Reset SRV
cycle counter”).
Revised January 2017

(2) Turn off the power of the main unit and wait approximately 30
seconds.
(3) Open the front cover of the main unit.

Sysmex XP-300 12-11


Cleaning and Maintenance

(4) Remove the SRV tray.

Caution!
When removing the SRV tray, take care not to loosen
the probe fixing screw.
SRV tray If analysis is made with the screw loosened, air can
Probe enter the system and affect the data.
fixing
screw

(5) Gently push down the rinse cup using both hands.
Sample probe
Make sure the rinse cup is removed completely from the sample
probe.

Caution!
If the rinse cup is not completely removed from the
sample probe, there is a possibility that the sample
Rinse cup probe may bend when the SRV is removed.

(6) Remove the SRV fixing screw.

SRV fixing screw

Loosen

(7) Remove the entire SRV.

Caution!
• Take care not to pull out the SRV excessively. This is
to prevent applying excess force to the tube
connected to the SRV.
SRV
• When removing the SRV, take care not to bend the
sample probe.
Revised January 2017

12-12 Sysmex XP-300


Cleaning and Maintenance

(8) Remove the rotary valve.

Fixed valve

Caution!
When removing each valve component, reagent could
leak from the tube. If it does, wipe it clean using cloth.
If left as it is, it can cause current leakage or electric
shocks.
Rotary valve

Note:
The valve components are in close contact with one
another. They can be easily removed when you slide each
one while twisting.

(9) Clean the rotary valve using distilled water or 1:10 dilution of
CELLCLEAN detergent. After cleaned with CELLCLEAN,
always clean it with distilled water.
(10) Clean the contact surfaces of the fixed and rotary valves using a
gauze moistened with distilled water. By using CELLCLEAN
together with distilled water, stuck objects, dirt, etc. can be
removed easily.

Caution!
• Take care not to inflict flaws or scratches on valve
surfaces, since flaws or scratches can cause blood
leakage and correct analysis results may not be
obtained.
• Do not use any other materials, like cleaning tissues
or Q-tips for cleaning which could loose parts of its
substance.

Information
Do not use any detergent other than CELLCLEAN.
Although the SRV is corrosion-resistant against
CELLCLEAN, rinse the SRV with distilled water
completely to prevent troubles to the unit or other
components.

(11) Make sure the valve contact surfaces are completely free from
dirt or dust.
Revised January 2017

Caution!
If the device is used with dirt or dust attaching on
valve contact surfaces, blood leakage can occur and
correct analysis results may not be obtained.

Sysmex XP-300 12-13


Cleaning and Maintenance

(12) Assemble the SRV in the reverse order to disassembly.


When assembling, make sure to install one each valve at a time.

Information
• Mount the rotary valve with the notch facing upward
and the metal knob coming between the stoppers.

Metal knob
Guide pin for rotary valve
Stopper
Groove

(View of left side)

• Confirm that the metal knob is between the stoppers.


If it is not, malfunction will occur.

Note:
Make sure, that the contact surfaces are wetted with
distilled water to ensure sealing.

(13) Mount the SRV tray to the original position and gently push up
the rinse cup to the top using both hands.

Information
• Mount the SRV tray properly as to its face/bottom
and the direction.
• Make sure the rinse cup is pushed all the way up with
the sample probe inserted in the hole. If the power is
turned on with the rinse cup staying lowered, [Rinse
motor error] will occur, making it impossible to
continue the operation.

(14) Close the front cover of the main unit.


(15) Turn on the main unit and make sure that the blank error has not
occurred.
(16) Perform quality control and make sure that there is no
functional problem.
Revised January 2017

12-14 Sysmex XP-300


Cleaning and Maintenance

12.9 Perform Auto Rinse


With the “Auto Rinse” function, all lines are cleaned and the waste is
drained.
Execute Auto Rinse to perform a background check, or when the unit
has been left idle without performing Shutdown.
(1) Press the [Menu] button at the Ready status.
The Menu screen will appear.

(2) Press the [Maint.] button.


The maintenance menu screen will appear.

(3) Press the [Auto Rinse] button.


The Auto Rinse starting confirmation dialog will appear.

(4) Press the [Execute] button.


The Auto Rinse and the Background check will be executed.
The background check is performed up to 3 times and, if in all
three background checks one parameter exceeds the limits, the
message [Blank Error] is displayed on the screen and an alarm
is sounded.

Information
See “Blank Error” in “13. Troubleshooting” to deal with
Blank error.
Revised January 2017

Sysmex XP-300 12-15


Cleaning and Maintenance

(5) When the Auto Rinse and Background check are normally
completed, the Main screen will appear.
Press the [Result] button and Background check result will
appear.

Revised January 2017

12-16 Sysmex XP-300


Cleaning and Maintenance

12.10 Clean rinse cup


When the rinse cup has any blood on it or is clogged, clean it by the
following procedure:

Risk of Infection
When cleaning the rinse cup, always wear rubber
gloves. After completion of work, wash hands with
disinfectant. If your hands are contaminated by blood,
etc., infection of bacteria can occur.

(1) Turn off the power of the main unit and wait approximately 30
seconds.
(2) Open the front cover of the main unit.
(3) Gently push down the rinse cup using both hands.
Sample probe
Make sure the rinse cup is removed completely from the sample
probe.

Rinse cup

(4) Remove the rinse cup in the order of (1), (2), and (3) as shown
on the left.

Rinse cup

(1)
(2)

(3)

(5) Clean the rinse cup using tap water.


(6) Make sure no contaminant remains on the rinse cup and wipe
off water.
Revised January 2017

Sysmex XP-300 12-17


Cleaning and Maintenance

(7) Mount the rinse cup in the reverse order of removal. Route the
thin tubes around the rear of the rinse cup.
(8) Gently push up the rinse cup to the top using both hands.
Rinse cup

Information
Make sure the rinse cup is pushed all the way up with
(3)
the sample probe inserted in the hole. If the power is
(2)
turned on with the rinse cup staying lowered, [Rinse
(1) motor error] will occur, making it impossible to
continue the operation.

Revised January 2017

12-18 Sysmex XP-300


Cleaning and Maintenance

12.11 Dispose waste fluid

Risk of Infection
• Always wear protective garments and gloves when
handling the waste fluid. After completion of work,
wash hands with disinfectant. Otherwise, there is a
risk of infection by pathogens.
• When handling (disposing) the waste fluid, dispose it
appropriately in accordance to local laws and
regulations, which considers for the disposal of
medical waste and infectious waste.

If the waste container is full, follow the procedure below to dispose


the waste fluid.
(1) Turn the main unit power off and wait approximately 30
seconds.
(2) Make ready an empty waste container and remove the cap.
(3) Pull the tube off the waste container that is full.
Tube
(4) Insert the tube in the new waste container and fix it using tape
Tape or the like.

Warning!
• CELLCLEAN is a strong alkaline cleaning solution.
Do not mix it with any acidic substances. Also, it
should not come in contact with skin or clothing. If
the skin or clothes should come in touch with it, flush
it away using plenty of water to avoid injury or
damage. Otherwise, it can damage the skin or
clothes.
• For disposing waste fluids, see “2.7 Disposal of
waste fluid, waste materials, and the device”.

Caution!
• Ensure that the waste container is secure and
properly connected before operating the instrument.
Waste fluid may discolor some materials.
• If the waste fluid is spilt, wipe off with the damp cloth
immediately.
• When using a used reagent container as the waste
container, make sure to clearly mark it that it is the
Revised January 2017

waste container.

Sysmex XP-300 12-19


Cleaning and Maintenance

12.12 Clean aperture of TD chamber (drain TD chamber)

Risk of Infection
Wear protective garments and gloves when cleaning
TD aperture of (draining TD chamber). After
completion of work, wash hands with disinfectant.
Otherwise, there is a risk of infection by pathogens.

If clogging of the aperture cannot be removed by cleaning the TD


(cleaning sequence), the aperture must be cleaned manually with a
transducer brush. Follow the procedures below.
(1) Press the [Menu] button at the Ready status.
The Menu screen will appear.

(2) Press the [Maint.] button.


The maintenance menu screen will appear.

(3) Press the [Drain TD Chamber] button.


The drain TD chamber screen will appear.
Revised January 2017

12-20 Sysmex XP-300


Cleaning and Maintenance

(4) Press the [Execute] button.


The sample fluid is drained from the TD chamber and a
message appears prompting the operator to turn the main power
switch OFF. Preparation for draining the TD chamber is
completed.
 When the [Cancel] button is pressed, the cleaning will be
discontinued, and the display returns to the Main screen.

(5) Turn the main power switch OFF, and wait for approx. 30
seconds.
Then disconnect the power cord.

Warning!
To avoid electrical shock, disconnect the power cord
before servicing.

(6) Open the front cover of the main unit.


Loosen (7) Open the transducer cover.

Warning!
When the power is on, never open the transducer
cover.
This is to prevent possible electric shocks.
Revised January 2017

Transducer
cover

Sysmex XP-300 12-21


Cleaning and Maintenance

(8) Confirm that the fluid in the TD chamber has been drained.
WBC
transducer RBC transducer

(9) Remove the TD chamber plug.

Caution!
A small volume of reagent occasionally remains.
When reagent has leaked, wipe it off immediately
Plug
using a damp cloth.
If left as it is, it can cause current leakage or electric
shocks.

Aperture (10) Apply CELLCLEAN on the brush provided, and dab by lightly
prodding the brush against the TD aperture.
Brush

Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water.
Otherwise, it can damage the skin or clothes.

Note:
After using the brush, wash it in water thoroughly to
remove the CELLCLEAN before storing it.

(11) Mount the TD chamber plug.

Caution!
The TD chamber plug should be mounted securely.
Otherwise, current leakage or electric shocks can occur.
Revised January 2017

(12) Close the transducer cover and main unit front cover. Then turn
on the power.
(13) Check that the blank error has not occurred.

12-22 Sysmex XP-300


Cleaning and Maintenance

12.13 Calibrate LCD screen


The LCD screen of this instrument is a touch panel system.
This section explains the calibration procedures of the touch panel
input positions. Calibrate the LCD if panel operation is not properly
aligned.
Calibrate according to the following procedures.
(1) Press the [Menu] button on the Main screen.
The Menu screen will appear.

(2) Press the [Maint.] button.


The maintenance menu screen will appear.

(3) Press the [Calibration LCD] button.


The calibration LCD start confirmation dialog will appear.
 Press the [OK] button to display the calibration LCD screen.
 Press the [Cancel] button to close the dialog.

(4) Press the center of “+” mark on the screen each time the “+”
mark is displayed.
The “+” mark will appear on the LCD in the following order: at
the center, the upper left, the lower left, the lower right, and the
upper right.
After completion of all “+” marks input, the calibration LCD
confirmation dialog screen will appear.
Revised January 2017

Sysmex XP-300 12-23


Cleaning and Maintenance

 Press the [OK] button to apply the calibration, and the Main
screen will appear.
 Press the [Cancel] button to return to the Main screen without
applying calibration.

Information
• If the input position was outside a regulated range,
the calibration error message will appear, and the
calibration will be discontinued.
• When calibration is performed and a calibration error
occurs frequently, there may be a problem with the
touch panel. Contact your Sysmex service
representative for further assistance.

Revised January 2017

12-24 Sysmex XP-300


Cleaning and Maintenance

12.14 Reset SRV cycle counter


If you have cleaned the SRV other than the time when prompted to
perform periodic maintenance, always reset the SRV cycle counter
manually.

Note:
• When the main power switch is turned ON, and if either the
counter value exceeds 4,500 or if 3 months have passed
since the last maintenance, a message will appear
prompting the operator to perform periodic maintenance
(SRV cycle counter reset).
• For details on SRV cleaning methods, see “12.8 Clean
SRV”.

(1) Press the [Menu] button at the Ready status.


The Menu screen will appear.

(2) Press the [Maint.] button.


The maintenance menu screen will appear.

(3) Press the [SRV reset] button.


The SRV reset dialog will appear.
Revised January 2017

Sysmex XP-300 12-25


Cleaning and Maintenance

(4) Press the [OK] button.


[Cycles after cleaning] is reset to “0”, and the LCD returns to
the maintenance menu screen.
Press the [Cancel] button to return to the maintenance menu
screen without resetting the number of cycles.

12.15 Adjust pressure and vacuum


The adjustment procedures described here are important in
maintaining accuracy of this instrument.
Your Sysmex service representative will perform initial adjustment.
Should it require any adjustment subsequently, follow the procedures
given below.
The following adjustment procedures are explained on the following
pages.
 Pressure: 0.05 MPa
 Vacuum: –0.0333 MPa
Pressure and vacuum from the built-in pneumatic unit are regulated
to 0.05 MPa and –0.0333 MPa. The pressure and vacuum are always
monitored by pressure sensors. When an error occurs, an error
message is displayed.
If the pressure or vacuum error message is displayed, check tubing
connections or the like for any air leakage. If there is no such error,
display the status display screen and adjust pressure or vacuum as
required.

Revised January 2017

12-26 Sysmex XP-300


Cleaning and Maintenance

Location of control knobs

Bellows unit Regulator

Note:
When an error has occurred, press in the error dialog to check pressure or vacuum value on the
action message screen.
(See “13. Troubleshooting”)
Revised January 2017

Sysmex XP-300 12-27


Cleaning and Maintenance

Adjusting pressure to 0.05 MPa

(1) Display the status display screen and check the current pressure
in the [Pressure] column.
For details about methods to display the status display screen,
see “12.2 Check instrument status”.
(2) Loosen the regulator locking nut on the left side of the unit.
(3) While watching the pressure and vacuum indication on the
status display screen, turn the adjusting knob to regulate
pressure and vacuum.
Low
Turn the adjusting knob clockwise to increase pressure and
vacuum.
Loosen

High Adjustment range: 0.039-0.059 MPa

Locking nut Adjusting knob Information


Always adjust pressure and vacuum so as to increase
to the predetermined levels. Should any of them be
too high, lower it to below that level once, then raise it
to the set level. Unless adjustment is properly
conducted, accurate adjustment may not be possible.

(4) When adjustment is finished, tighten the locking nut while


taking care not to allow the adjusting knob to rotate.
(5) Press the [Top] button to close the status display screen.

Revised January 2017

12-28 Sysmex XP-300


Cleaning and Maintenance

Adjusting vacuum to –0.0333 MPa

(1) Display the status display screen and check the current vacuum
in the [Vacuum] column.
For details about methods to display the status display screen,
see “12.2 Check instrument status”.
(2) By turning counterclockwise, loosen the locking nut for the
bellows unit on the left side of the unit.
(3) While watching the pressure and vacuum indication on the
status display screen, turn the adjusting knob to regulate
Low High
pressure and vacuum.
Turn the adjusting knob clockwise to increase pressure and
vacuum.

Adjustment range: (–0.0307) - (–0.0360) MPa

Adjusting knob Locking nut Information


Always adjust pressure and vacuum so as to increase
to the predetermined levels. Should any of them be
too high, lower it to below that level once, then raise it
to the set level. Unless adjustment is properly
conducted, accurate adjustment may not be possible.

(4) When adjustment is finished, tighten the locking nut while


taking care not to allow the adjusting knob to rotate.
(5) Press the [Top] button to close the status display screen.
Revised January 2017

Sysmex XP-300 12-29


Cleaning and Maintenance

12.16 Replace reagent

Risk of Infection
Always wear protective garments and gloves when
replacing reagents. After completion of work, wash
hands with disinfectant. Otherwise, there is a risk of
infection by pathogens.

During the operation, instrument will automatically stop and an error


dialog will appear if a reagent runs out.
To replace the reagent, follow the procedure below.

Error message Reagent to be replaced


[Replace CELLPACK] CELLPACK
[Replace STROMATOLYSER] STROMATOLYSER-WH

(1) Make ready a new reagent and make sure that it has not passed
its expiration date.

Caution!
• Leave the reagents at room temperature (15 -
30°C) for at least 24 hours or longer before using.
If a reagent that has arrived recently is used, a
correct analysis result may not be obtained.
• Use the reagent at 15 - 30°C. When analyzed with
reagent of a temperature higher than 30°C or lower
than 15°C, a correct analysis result may not be
obtained.
• Always use new reagents.
• Do not use any left-over reagents.
• Do not allow the reagents to freeze.
• Take care to prevent dust, dirt, bacteria, or other
materials from entering the reagent after it is
opened. Otherwise, there is a possibility that
proper analysis cannot be performed.
Shelf life after first opening
CELLPACK 60 days
STROMATOLYSER-WH 90 days
Revised January 2017

12-30 Sysmex XP-300


Cleaning and Maintenance

(2) Remove the cap from the new reagent container.


Container (3) Remove the cap from the empty reagent container and pull the
spout kits
container spout kit straight out to remove it.
(4) Insert the container spout kit immediately straight into the new
reagent container, then tighten the cap.

Reagent container

Caution!
• Take care not to touch the pipe that enters the
reagent with your hands, or to allow dust or other
substances to adhere to them. If such substances
adhere to the pipe, first wash the substance off with
reagent before attaching the container spout kit.
Otherwise, there is a possibility that proper analysis
cannot be performed.
• Take sufficient care to prevent the reagent from
spilling. If the reagent spills, immediately wipe it off
with a damp cloth or similar material. The reagent
may cause discoloration of surfaces.

(5) Press the [Menu] button on the Main screen.


To execute from the error help screen, press the [Execute]
button. (proceed to (8).)

(6) Press the [Chg.Reag] button.


The reagent information screen will appear.
Revised January 2017

Sysmex XP-300 12-31


Cleaning and Maintenance

(7) Press the [CELLPACK] button to replace CELLPACK.


Press the [S.LYSER] button to replace STROMATOLYSER-
WH.
The reagent bar code entering screen will appear.
* Pressing the [Top] button on the reagent information screen
displays the replace reagent quit conformation dialog. Press
the [OK] button to return to the Main screen without
replacing the reagent or the [Cancel] button to close the
dialog to continue the reagent replacement operation.
(8) Input the bar code of the new reagent.
Use the numerical keys dialog or handheld bar code reader to
enter the reagent bar code.
 Input from the numerical keys dialog
Press the [CODE] display column on the reagent bar code
entering screen.
A numeric keypad is displayed. Input the alphanumeric
characters described on the bar code label affixed on the new
reagent, then press [Ent.].
 Input from the handheld bar code reader
Have the bar code reader read the bar code label of the
reagent with the reagent bar code entering screen displayed.

Information
Make sure to read [Reagent code2]. Reading
[Reagent code] will result in an error.

Note:
If an input error or reading error occurs, the reagent bar
code reentry confirmation dialog appears. The value that
was entered last time is displayed in gray. Pressing the
[Reentry] button turns the CODE display column blank
and allows reentry of the reagent bar code.

When the bar code is read successfully, the reagent information


is displayed on the bar code entering screen and the input
confirmation dialog is displayed.
A 5-digit number starting with an alphabetical character is
displayed for the Lot No.
(9) Press the [OK] button.
The replace reagent confirmation dialog is displayed.
* Pressing the [Top] button on the reagent bar code entering
screen displays the replace reagent quit conformation dialog.
Press the [OK] button to return to the Main screen without
Revised January 2017

replacing the reagent or the [Cancel] button to close the


dialog to continue the reagent replacement operation.

12-32 Sysmex XP-300


Cleaning and Maintenance

(10) Press the [Execute] button.


The reagent replacing dialog screen will appear, and reagent
aspiration will be performed.
 In case the [Cancel] button is pressed, the reagent replacing
operation is canceled, and the instrument returns to the Main
screen.
When the process is finished, the Main screen will appear.

Reagent replacement log

Up to 100 data can be confirmed in the reagent replacement log.

Information
If the data records exceed 100, the oldest data is
automatically deleted.

(1) Press the [Reag. Log] on the reagent information screen.


The reagent replacement history screen will appear.
Revised January 2017

Sysmex XP-300 12-33


Cleaning and Maintenance

Reagent replacement history screen

Replacement logs for individual reagents are displayed on the reagent replacement history screen.
When the reagent replacement history screen is displayed, the cursor appears on the latest data.
The reagent replacement history screen is consisted of 4 screens, and the following information is displayed
on the individual screens:

First reagent replacement history screen Replaement date and time, lot No., expiration date
Second reagent replacement history screen Serial No., product code (product name), shelf life after first opening
Third reagent replacement history screen Manufacturer or distributor
Fourth reagent replacement history screen Address of the manufacturer or distributor

Reagent name

Replacement log No. Information on the


reagents replaced

Example: First reagent replacement history screen (CELLPACK)

Description of the reagent replacement history screen

Reagent name: Indicates the name of the reagent whose replacement log is
displayed on the screen. [CELLPACK] is displayed for
CELLPACK and [S.LYSER] for STROMATOLYSER-
WH.
Replacement log No.: Numbered to run from the oldest to the newest. The number
of up to “100” is displayed.
Information on the reagent replaced: Displays the information on the reagents that have been
replaced for individual log numbers.
[More]: Changes the screen to STROMATOLYSER-WH
replacement logs when displaying the CELLPACK
replacement log screen, and to CELLPACK replacement
logs when displaying STROMATOLYSER-WH
replacement log screen.
[IP]: Prints 10 replacement logs that are displayed on the screen.
Revised January 2017

This button dims while printing.


[]: Moves to the previous log data.
However, when the oldest data is displayed, this button
operation becomes invalid.

12-34 Sysmex XP-300


Cleaning and Maintenance

[]: Moves to the next log data.


However, when the latest data is displayed, this button
operation becomes invalid.
[]: Changes the screens in the following order; “First reagent
replacement history screen”  “Second reagent replacement
history screen”  ...  “Fourth reagent replacement history
screen”  “First reagent replacement history screen”.

12.17 Replace system fuses


The main unit employs overcurrent protective fuses. When a fuse is
blown, replace it by the following procedure:
(1) Disconnect the power cord on the right side of the main unit.

Warning!
Before replacing the fuse, always turn off the power
and disconnect the power cord.
This is to prevent possible electric shocks.

(2) Pressing the notch upward with a regular screwdriver, remove


the fuse cap holder.
Fuse
(3) Replace the fuse and mount the fuse cap holder.

Caution!
For continued protection against risk of fire, use the
fuse of the specified type and rating.
Fuse cap holder
Notch This is to prevent possible smoke.

Specification Part No. Description Fuse


Type
120 VAC 266-5011-3 Fuse 250V 4A Time Lag
ST4-4A-N1
230/240 VAC AX880901 Fuse 250V 3.15A Time Lag
50T032H
Revised January 2017

Sysmex XP-300 12-35


Cleaning and Maintenance

12.18 Replace internal printer paper (Printing Paper No. 3)


(1) Open the front cover of the main unit.

Information
When the tip of printer paper extends from the upper
part of the internal printer, cut off the paper and then
open the front cover.

(2) Push down the lock lever.


Lock lever Lock is released and the printer cover is pulled open toward the
front.
Printer cover (3) Remove the bare paper core and mount the new printer paper.

Note:
When any printer paper remains, remove it together with
New printer paper the paper core.
(Printing Paper
No. 3)

(4) Pass the printer paper through along the paper guides.

Paper
guide
Revised July 2017

12-36 Sysmex XP-300


Cleaning and Maintenance

(5) Push the printer cover back in position until it locks.


Press the button (paper feed button) to confirm that the
printer paper is fed correctly.

Information
• Be sure to set the printer paper straight in the right
direction. If the printer paper is crooked, the paper
may jam.
• Make sure the printer cover is securely closed.
If the cover is not securely closed, a printing error or
Printer head
incorrect output may result.

Caution, Hot!
The printer head becomes hot. Use caution.

Caution!
Static electricity may damage the printer head. Do not
touch with hands.

(6) Cut off any printer paper extending from the upper part of the
printer.

(7) Close the front cover of the main unit.


Revised July 2017

Sysmex XP-300 12-37


Cleaning and Maintenance

12.19 List of consumables

Note:
It is recommended to always keep a sufficient amount of
the following supplies and consumables available. This will
assure that your instrument is available for use.

Reagents list

Product name Volume General name


PK-30L 20 L Diluent (CELLPACK)
CPK-310A 10 L Diluent (CELLPACK)
SWH-200A 500 mL × 3 WBC/HGB lyse (STROMATOLYSER-WH)
CL-50 50 mL Detergent (CELLCLEAN)

Note:
A 20 L or 10 L Cubitainer spout kit is required when you use CELLPACK.
For details, contact your Sysmex service representative.

943-1781-1 Cubitainer Spout Kit No. 1 (for 20 L)


943-1782-4 Cubitainer Spout Kit No. 1 (for 10 L)

Consumable list

Part No. Product name Chapter & Section for reference


933-3601-9 Transducer Brush No.1 “12.12 Clean aperture of TD chamber
(drain TD chamber)”
AV258119 Printing Paper NO.3/5P “12.18 Replace internal printer paper
(Printing Paper No. 3)”
266-5011-3 Fuse 250V 4A ST4-4A-N1 “12.17 Replace system fuses”
AX880901 Fuse 250V 3.15A 50T032H
Revised January 2017

12-38 Sysmex XP-300


Troubleshooting

13. Troubleshooting
If the instrument shows any signs that indicate a malfunction during
operation, be sure to first check “13.1 When you suspect an error” on
the following pages. If the corresponding item is not found, or if the
procedure listed under “Action” does not eliminate the signs of
trouble, contact your Sysmex service representative.
 Other errors are indicated by a beep and a message is then
displayed on the LCD screen.
 If an error affects only a specific analysis result, it will be
marked by a flag.

Warning!
Disconnect the power cord before opening the
instrument.
Otherwise there is a risk of personal injury by
electrical shock and possible damage to the
instrument.

Information
• If you are unable to rectify the error, contact your
Sysmex service representative for further assistance.
Before doing so, make a note of the exact ERROR
CODE in the Help screen to enable your service
representative to provide assistance quickly.
• In case of a power failure during operation, turn the
main power switch OFF.
Revised January 2017

Sysmex XP-300 13-1


Troubleshooting

13.1 When you suspect an error

Trouble Action
The logo appears on the LCD The program card may have come out of the slot.
screen, however the Main Turn the main power switch OFF, and check that the program card is
screen does not appear. securely inserted in the card slot at the back of the instrument. Then turn
the main power switch ON again.
If the error persists, contact your Sysmex service representative.
The instrument is switched  Check if power cord is plugged in properly.
ON but will not start.  Check if the fuse(s) are blown.
 Use another appliance to check if the outlet is live.
After turning the main power A memory error may have occurred. Turn the main power switch OFF,
switch ON, the LCD screen wait 1 to 2 minutes, then turn the main power switch ON again.
remains blank. If the error persists, contact your Sysmex service representative.
Mechanical operation is heard, Check that the LCD screen contrast is set correctly.
but no display appears on
LCD screen.
Fluid leaks from the Turn the main power switch OFF and wipe off the leaked fluid.
instrument. If fluid leaks persist after the main power switch is turned ON, contact
your Sysmex service representative.

Risk of Infection
Wear protective garments and gloves when working.
After completion of work, wash hands with
disinfectant.
If your hands are contaminated by blood, etc.,
infection of bacteria can occur.

Revised January 2017

13-2 Sysmex XP-300


Troubleshooting

13.2 Error messages

General

When an error occurs, a beep alarm sounds, the button flashes,


and an error dialog appears on the LCD screen.
 Press the [OK] button to stop the alarm beep and close the error
dialog screen.
 Press the button to display the steps for rectifying the error
on the LCD screen.
 If multiple errors occur simultaneously, they are displayed
ranked by importance.
 Press the [Detail] button.
The help screen of the error at the top of the list will be
displayed.
 Follow the instructions.
 Press the [Detail] button to go to the next screen.
 Press the [Back] button to close the screen.
 If the error persists, contact your Sysmex service representative.
Revised January 2017

Sysmex XP-300 13-3


Troubleshooting

Alphabetical error message index


–0.0333MPa Vacuum Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
0.05MPa Pressure Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Aperture Clog (RBC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Aperture Clog (WBC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Blank Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
CELLPACK expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10
Clean the SRV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
Clean Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
Clean Waste Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
GP Buffer Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
GP paper empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
GP printout error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
HC ACK Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
HC Buffer Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-19
HC NAK Retry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
HC Off-line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
HGB Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
IP Cover Open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-18
LAN Buffer Full. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-19
LAN no Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-19
No Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-18
PLT Noise Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
PLT Smp’g Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
Pressure/Vac Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
Print Buffer Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-18
QC Data Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
QC Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
QC(L-J) Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
QC(X-bar) Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
RAM Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
RBC Analysis Err. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
RBC Noise Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
RBC Smp’g Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
Replace CELLPACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
Replace STROMATOLYSER . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
Rinse MC error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Rinse motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
ROM Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
Room Temp(H) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
Room Temp(L). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
S.LYSER expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10
Settings Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
SNCS Comm. Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
SNCS Connection Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
SNCS Setting Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
SNCS Status Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
Revised January 2017

Stored Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15


Waste not drained. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
WBC Analysis Err . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
WBC Noise Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
WBC Smp’g Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13

13-4 Sysmex XP-300


Troubleshooting

Error massage index by function

1. Pressure/Vacuum Errors
0.05MPa Pressure Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
–0.0333MPa Vacuum Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Pressure/Vac Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8

2. Chamber Errors
Waste not drained. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
Replace CELLPACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
Replace STROMATOLYSER . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
CELLPACK expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10
S.LYSER expired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10

3. Motor Errors
Rinse motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Rinse MC error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11

4. TD Errors
Aperture Clog (WBC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Aperture Clog (RBC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11

5. Temperature Errors
Room Temp(H) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
Room Temp(L) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12

6. Analysis Errors
Blank Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
PLT Smp’g Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
RBC Smp’g Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
WBC Smp’g Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
PLT Noise Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
RBC Noise Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
WBC Noise Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
HGB Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
WBC Analysis Err . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
RBC Analysis Err. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
Revised January 2017

Sysmex XP-300 13-5


Troubleshooting

7. Memory Errors
RAM Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
ROM Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
Stored Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
Settings Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
QC Data Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15

8. Others
QC(L-J) Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
QC(X-bar) Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
QC Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16

9. Maintenance Errors
Clean the SRV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
Clean Waste Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
Clean Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17

10. Internal Printer Errors


Print Buffer Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-18
No Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-18
IP Cover Open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-18

11. External Output Errors (when connected with optional


equipment)
HC Buffer Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-19
LAN no Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-19
LAN Buffer Full. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-19
HC Off-line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
HC ACK Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
HC NAK Retry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
GP printout error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
GP paper empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-20
GP Buffer Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21

12. SNCS Errors


SNCS Comm. Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
SNCS Connection Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
SNCS Setting Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
Revised January 2017

SNCS Status Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21

13-6 Sysmex XP-300


Troubleshooting

13.3 Error messages, possible causes and actions to revolve the error

Note:
An error subcode may be displayed after the error code.
The subcode is for Sysmex service representative use only.

1. Pressure/Vacuum Errors

Error Message 0.05MPa Pressure Error (113005)


(Error Code)
Cause Pressure was not within the monitored range (0.039 - 0.059 MPa) due to the
following reason(s):
 0.05 MPa pressure adjustment error
 Pneumatic unit pressure error
 Air leakage from pressure line
Action Adjust pressure to 0.05 MPa.
Current pressure will be displayed real-time on the LCD screen. Adjust pressure
by referring to “Adjusting pressure to 0.05 MPa” in “12.15 Adjust pressure and
vacuum”.
Troubleshooting After adjustment and checking, press the [Back] button to
on the screen clear the error and perform the recovery process.
Note  The analysis result with an error is masked on the screen.
 The status is not ready for analysis, but the processing, etc. of stored data can
be performed.

Error Message –0.0333MPa Vacuum Error (114010)


(Error Code)
Cause Vacuum was not within the monitored range ((–0.0307) - (–0.0360) MPa) due to
the following reason(s):
 –0.0333 MPa vacuum adjustment error
 Fluid back-flows into the trap chamber
 Pneumatic unit vacuum error
 Air leakage from vacuum line
Action  Adjust vacuum to –0.0333 MPa.
Current vacuum will be displayed real-time on the LCD screen. Adjust
vacuum by referring to “Adjusting vacuum to –0.0333 MPa” in
“12.15 Adjust pressure and vacuum”.
 Discard fluid in Trap Chamber.
Discard fluid if collected. Refer to “12.4 Check trap chamber level and
discard”.
Revised January 2017

Troubleshooting After adjustment and checking, press the [Back] button to


on the screen clear the error and perform the recovery process.
Note  The analysis result with an error is masked on the screen.
 The status is not ready for analysis, but the processing, etc. of stored data can
be performed.

Sysmex XP-300 13-7


Troubleshooting

Error Message Pressure/Vac Error (119010)


(Error Code)
Cause Pressure fell below 0.02 MPa due to the following reason(s):
 0.05 MPa pressure adjustment error
 Pneumatic unit pressure error
 Air leakage from pressure line
Action Adjust pressure to 0.05 MPa.
Turn the main power switch OFF, then ON again. After that, adjust pressure by
referring to “Adjusting pressure to 0.05 MPa” in “12.15 Adjust pressure and
vacuum”.
Note  The power needs to be turned OFF then ON again.
 The status is not ready for analysis, but the processing, etc. of stored data can
be performed.

2. Chamber Errors

Error Message Waste not drained (141000)


(Error Code)
Cause  Breakage or clogging of waste chamber or waste line tube
 Pneumatic unit pressure error
 Air leakage from pressure line
 Float switch malfunction
 Faulty operation of solenoid valve or master valve
Action Check waste line tube.
Check the waste drain line for breakage, clogging, etc. If any abnormality is
present, clean or replace the tube. Specially check for contaminant or clogging
near the drain outlet nipple.
Troubleshooting After adjustment and checking, press the [Execute] button to
on the screen clear the error, and the waste chamber drain sequence is
executed.
Note  Not ready until the error is resolved.
 The status is not ready for analysis, but the processing, etc. of stored data can
be performed.
Revised January 2017

13-8 Sysmex XP-300


Troubleshooting

Error Message Replace CELLPACK (131000)


(Error Code)
Cause  Lack of diluent (CELLPACK)
 Diluent aspiration line error
 Air leakage from vacuum line
 Float switch malfunction
 Faulty operation of solenoid valve or master valve
 Use in excess of the specified number of analyses for a container
Action  Replenish diluent (CELLPACK).
If there is no diluent or the volume is insufficient, replace with a new diluent
container.
 Check tube.
Check the diluent line tubing for breakage and the nipple for looseness. If any
abnormality is noted, reconnect or replace.
Troubleshooting Replace with a new reagent and press the [Execute] button.
on the screen The error is cleared and the reagent replacement sequence is
executed.
Refer to “12.16 Replace reagent”.
However, an error occurs again if the reagent replacement
sequence is not completed correctly.
Note  Not ready until the error is resolved.
 The status is not ready for analysis, but the processing, etc. of stored data can
be performed.

Error Message Replace STROMATOLYSER (133220)


(Error Code)
Cause  Lack of lyse (STROMATOLYSER-WH)
 Float switch malfunction
 Use in excess of the specified number of analyses for a bottle.
Action  Replenish lyse (STROMATOLYSER-WH).
If there is no lyse or the volume is insufficient, replace with a new lyse
container.
 Check the lyse tubing for breakage. If any abnormality is noted, reconnect or
replace.
Troubleshooting Replace with a new reagent and press the [Execute] button.
on the screen The error is cleared and the reagent replacement sequence is
executed.
Refer to “12.16 Replace reagent”.
However, an error occurs again if the reagent replacement
sequence is not completed correctly.
Note  Not ready until the error is resolved.
 The status is not ready for analysis, but the processing, etc. of stored data can
Revised January 2017

be performed.

Sysmex XP-300 13-9


Troubleshooting

Error Message CELLPACK expired (472020)


(Error Code)
Cause Expiration date of the CELLPACK has expired.
Action  Replace the CELLPACK.
Replace with a CELLPACK of which expiration date has not expired.
Troubleshooting Replace with a new reagent and press the [Execute] button.
on the screen The error is cleared and the reagent replacement sequence is
executed.
Refer to “12.16 Replace reagent”.
However, an error occurs again if the reagent replacement
sequence is not completed correctly.

Error Message S.LYSER expired (472034)


(Error Code)
Cause Expiration date of the STROMATOLYSER has expired.
Action  Replace the STROMATOLYSER.
Replace with a STROMATOLYSER of which expiration date has not
expired.
Troubleshooting Replace with a new reagent and press the [Execute] button.
on the screen The error is cleared and the reagent replacement sequence is
executed.
Refer to “12.16 Replace reagent”.
However, an error occurs again if the reagent replacement
sequence is not completed correctly.

Revised January 2017

13-10 Sysmex XP-300


Troubleshooting

3. Motor Errors

Error Message Rinse motor error (243000)


(Error Code)
Cause  Rinse cup drive motor malfunction
 The power was turned ON with the rinse cup remaining lowered.
Action Turn OFF the power, manually raise the rinse cup with both hands to the original
top position, then turn ON the power.
Note  The power needs to be turned OFF then ON again.
 The status is not ready for analysis, but the processing, etc. of stored data can
be performed.

Error Message Rinse MC error (452030)


(Error Code)
Cause  Rinse cup drive motor malfunction
 Error of the rinse cup drive motor controller (control board)
 Faulty operation of CPU due to sudden noise interference, etc.
Action  Turn OFF the power and check to see that tubing, etc. are not in contact with
the top or bottom of rinse cup.
 Turn OFF the power and clean the rinse cup.
Refer to “12.10 Clean rinse cup”.
Note  The power needs to be turned OFF then ON again.
 The status is not ready for analysis, but the processing, etc. of stored data can
be performed.

4. TD Errors

Error Message Aperture Clog (WBC) (311140)


(Error Code) Aperture Clog (RBC) (311240)
Cause TD aperture clogging
Action  Remove aperture clogging.
Follow the instructions in the “Troubleshooting on the screen” below.
 TD rinse sequence
The sequence automatically cleans the TD after CELLCLEAN is set to the
sample probe.
Refer to “12.6 Clean TD”.
 Clean the TD with brush.
Clean the aperture using brush.
Refer to “12.12 Clean aperture of TD chamber (drain TD chamber)”.
Troubleshooting Press the [Execute] button to clear the error, and the clog
on the screen removal is executed.
Revised January 2017

Note  The analysis result with an error is masked on the screen.


 Although the system is ready for analysis, the error may occur in the next
analysis.

Sysmex XP-300 13-11


Troubleshooting

5. Temperature Errors

Error Message Room Temp(H) (122510)


(Error Code) Room Temp(L) (122515)
Cause Temperature in the TD is high (or low.)
(Monitor range: 10.0 - 40.0ºC)
Action  Check the ambient temperature.
Check to see that the ambient temperature is between 15ºC - 30ºC.
 If the temperature in the TD is too high or low, perform shutdown of the
instrument. Leave the instrument at an appropriate room temperature for
some time, then turn the main power switch ON again.
Note  The analysis result with an error is masked on the screen.
 Although the system is ready for analysis, the error may occur in the next
analysis.

6. Analysis Errors
Error Message Blank Error (411010)
(Error Code)
Cause Background counts did not fall below the acceptable level during the background
check due to the following reason(s):
 Dirty aperture
 Dirty HGB flow cell
 Bubbles mixing
 Faulty reagent
Action  Auto Rinse
Follow the instructions in the “Troubleshooting on the screen” below.
 Clean TD.
Refer to “12.6 Clean TD” or “12.12 Clean aperture of TD chamber (drain TD
chamber)”.
 Clean SRV.
Refer to “12.8 Clean SRV”.
 Replenish reagent.
Faulty lyse will affect background for WBC or HGB. In case diluent is faulty,
it will affect all parameters, notably PLT background count.
Troubleshooting Press the [Execute] button to clear the error, and the auto
on the screen rinse program is executed.
Note Ready for analysis (although the next sample could be affected)
Revised January 2017

13-12 Sysmex XP-300


Troubleshooting

Error Message PLT Smp’g Error (413030)


(Error Code) RBC Smp’g Error (413020)
WBC Smp’g Error (413010)
Cause Dispersion of counts per unit time was not within the acceptable range during
analysis due to the following reason(s):
 Dirty aperture
 Effect of external noise interference
 Uneven concentration of sample
Action  Clean TD.
(1) Remove aperture clogging.
Follow the instructions in the “Troubleshooting on the screen” below.
(2) TD rinse sequence
The sequence automatically cleans the TD after CELLCLEAN is set to
the sample probe. Refer to “12.6 Clean TD”.
(3) Clean the TD with brush.
Clean the aperture using brush.
Refer to “12.12 Clean aperture of TD chamber (drain TD chamber)”.
 Remove the source of external noise.
Move the noise source away from the unit.
Troubleshooting Press the [Execute] button to clear the error, and the clog
on the screen removal is executed.
Note  The analysis result with an error is masked on the screen.
 Although the system is ready for analysis, the error may occur in the next
analysis.

Error Message PLT Noise Error (412030)


(Error Code) RBC Noise Error (412020)
WBC Noise Error (412010)
Cause Effects of external electric noise interference. Control board malfunction.
Action Separate the source of electric noise from the instrument.
Note  The analysis result with an error is masked on the screen.
 Although the system is ready for analysis, the error may occur in the next
analysis.
Revised January 2017

Sysmex XP-300 13-13


Troubleshooting

Error Message HGB Error (415000)


(Error Code)
Cause HGB background count or HGB sample value was not within the acceptable range
due to the following reason(s):
 Dirty HGB flow cell
 Bubbles mixed in HGB sample line
 Dirty WBC TD chamber
Action  Clean TD
Follow the instructions in the “Troubleshooting on the screen” below.
Refer to “12.6 Clean TD”.
Troubleshooting Press the [Execute] button to clear the error, and the TD
on the screen cleaning is executed.
Note  The analysis result with an error is masked on the screen.
 Although the system is ready for analysis, the error may occur in the next
analysis.

Error Message WBC Analysis Err (416100)


(Error Code)
Cause The histogram could not be accurately and continuously discriminated due to the
following reason(s):
 Dirty aperture
 Faulty lyse (STROMATOLYSER-WH)
Action  Clean TD.
Refer to “12.6 Clean TD” or “12.12 Clean aperture of TD chamber (drain TD
chamber)”.
 Replenish lyse (STROMATOLYSER-WH).
Note  The analysis result with an error is masked on the screen.
 Although the system is ready for analysis, the error may occur in the next
analysis.

Error Message RBC Analysis Err (417080)


(Error Code)
Cause A monitor indicated that diluent characteristics were not within an acceptable
range due to faulty diluent (CELLPACK).
Action Replenish diluent (CELLPACK).
Note  The analysis result with an error is masked on the screen.
 Although the system is ready for analysis, the error may occur in the next
analysis.
Revised January 2017

13-14 Sysmex XP-300


Troubleshooting

7. Memory Errors

Error Message RAM Error (431010)


(Error Code) ROM Error (431020)
Cause Momentary power failure, sudden noise interference, etc. causes CPU
malfunction.
Action Turn OFF then ON the power again.
Note Applications cannot be started.
Notifies the operator of the error by an alarm sound because it cannot be displayed
on the screen.

Error Message Stored Error (432010)


(Error Code) Settings Error (431030)
QC Data Error (463000)
Cause Momentary power failure or sudden noise interference causes stored data/QC data/
set value errors.
Action Troubleshooting  Follow the instructions on the screen to “repair” the
on the screen data storage area. Then restart the instrument.
If “repair” is not successful, then “initialize” the data
storage area.
 When the instrument is initialized, all stored data is
deleted. If settings have been initialized, reenter the
settings.
 If either “repair” or “initialize” is successful, the
program will be started.
Note Analysis is not ready. Not ready until the error is resolved.
Revised January 2017

Sysmex XP-300 13-15


Troubleshooting

8. Others

Error Message QC(L-J) Error (461160)


(Error Code) QC(X-bar) Error (461150)
Cause QC analysis results were beyond the control limit, or [+++.+], [] or [---.-]
was displayed due to the following reason(s):
 Control blood aspiration error
 Control blood insufficient mixing
 Faulty control blood
 TARGET value or LIMIT value was input wrong.
 Instrument failure
Action  Reanalyze control blood.
 Confirm TARGET value and LIMIT value.
Note Ready for analysis.

Error Message QC Error (466010)


(Error Code)
Cause  Input error of target or calibration values
 Instrument failure caused data to shift.
Action  Execute calibration again.
Press the [Back] button and execute calibration again from the beginning.
 Maintenance of instrument
Check QC data, and if data is found to have shifted, a hardware problem is
conceivable.
Referring to “12. Cleaning and Maintenance”, clean the TD, SRV, etc.
Note Analysis is not ready. Not ready until calibration value is fixed.

Revised January 2017

13-16 Sysmex XP-300


Troubleshooting

9. Maintenance Errors

Error Message Clean the SRV (471010)


(Error Code)
Cause 3 months have passed since the last maintenance or the number of samples
analyzed exceeds 4,500.
Action Troubleshooting Press the [OK] button.
on the screen Following the instructions on the screen, turn OFF the power
and clean the SRV. (Refer to “12.8 Clean SRV”).
If you perform cleaning later, press the [Cancel] button. This
activates the usual startup sequence and makes the system
Ready.
* The same message will appear the next time you start the
unit; it will be displayed at each startup until the cleaning is
performed.
Note If SRV cleaning is performed without pressing the [OK] button, reset the SRV
cycle counter by referring to “12.14 Reset SRV cycle counter”.

Error Message Clean Waste Chamber (471030)


(Error Code)
Cause 1 month has passed since the last maintenance or the number of samples analyzed
exceeds 1,500.
Action Set CELLCLEAN to the sample probe and clean the waste chamber. (Refer to
“12.7 Clean waste chamber”.)
If you perform cleaning later, press the [Cancel] button. This activates the usual
startup sequence and makes the system Ready.
* The same message will appear the next time you start the unit; it will be
displayed at each startup until the cleaning is performed.
Note When the waste chamber rinse sequence has been completed, the cycle counter is
automatically reset.

Error Message Clean Transducer (471100)


(Error Code)
Cause 1 month has passed since the last maintenance or the number of samples analyzed
exceeds 1,500.
Action Use CELLCLEAN to clean the WBC transducer and RBC transducer. (Refer to
“12.6 Clean TD”.)
If you perform cleaning later, press the [Cancel] button. This activates the usual
startup sequence and makes the system Ready.
* The same message will appear the next time you start the unit; it will be
displayed at each startup until the cleaning is performed.
Note
Revised January 2017

When the TD rinse sequence has been completed, the cycle counter is
automatically reset.

Sysmex XP-300 13-17


Troubleshooting

10. Internal Printer Errors

Error Message Print Buffer Full (448010)


(Error Code)
Cause Momentary power failure or sudden noise interference causes printer memory
errors.
Action Troubleshooting Press the [Back] button to clear the error. However, the data
on the screen under printing will be printed.
Note Analysis is ready when the error is cleared.

Error Message No Printer Paper (448020)


(Error Code)
Cause No printer paper in the internal printer
Action Troubleshooting  After refilling paper in the internal printer, press the
on the screen [Retry] button to clear the error, and the data under
printing will be printed from the beginning by one
sample.
Refer to “12.18 Replace internal printer paper (Printing
Paper No. 3)”.
 Press the [Cancel] button to cancel the data under
printing, also discard the waiting data, and the error is
cleared.
Note Analysis is ready when the error is cleared.

Error Message IP Cover Open (421502)


(Error Code)
Cause The printer cover is open.
Action Troubleshooting  Close the printer cover and press the [Retry] button.
on the screen The error is cleared and the data under printing will be
printed.
 Press the [Cancel] button to cancel the data under
printing, also discard the waiting data, and the error is
cleared.
Note Analysis is ready when the error is cleared.
Revised January 2017

13-18 Sysmex XP-300


Troubleshooting

11. External Output Errors (when connected with optional equipment)

Error Message HC Buffer Full (441010)


(Error Code)
Cause  Computer connecting cable failure
 Computer is not turned ON or not ready for communication.
 Host computer serial interface error
Action  Inspect the host computer.
 Inspect the connection cable.
Troubleshooting Press the [Back] button to clear the error.
on the screen However, the data under printing will be printed. Other data
will be deleted.
Note Analysis is ready when the error is cleared.

Error Message LAN no Response (486000)


(Error Code)
Cause  Computer connecting cable failure
 Computer is not turned ON or not ready for communication.
 LAN connector for host computer failure
Action  Inspect the host computer.
 Inspect the connection cable.
Troubleshooting  Press the [Retry] button to clear the error, and the
on the screen transmission to LAN is restarted.
 Press the [Cancel] button to clear the error. All data for
LAN output is deleted.
Note Analysis is ready when the error is cleared.

Error Message LAN Buffer Full (486030)


(Error Code)
Cause The amount of data for output or printout is too large to be processed.
Action Troubleshooting Press the [Back] button to clear the error.
on the screen However, the data under printing will be printed. Other data
will be deleted.
Note Analysis is ready when the error is cleared.
Revised January 2017

Sysmex XP-300 13-19


Troubleshooting

Error Message HC Off-line (441020)


(Error Code) HC ACK Timeout (441030)
HC NAK Retry (442020)
Cause  Computer connecting cable failure
 Computer is not turned ON or not ready for communication.
 Host computer serial interface error
Action  Inspect the host computer.
 Inspect the connection cable.
Troubleshooting  Press the [Retry] button to clear the error, and the
on the screen transmission to the host computer is restarted.
 Press the [Cancel] button to clear the error, and all the
output queued strings to host computer are deleted.
Note Analysis is ready when the error is cleared.

Error Message GP printout error (443010)


(Error Code)
Cause The external printer has an error.
Action  Check if the external printer power is turned ON.
 Check if the external printer cable is properly connected.
Troubleshooting  After checking the external printer, press the [Retry]
on the screen button to clear the error, and the data under printing will
be printed from the beginning by one sample.
 After checking the external printer, press the [Cancel]
button to cancel the data under printing, also discard the
waiting data, and the error is cleared.
Note Analysis is ready when the error is cleared.

Error Message GP paper empty (443020)


(Error Code)
Cause No printer paper in the external printer
Action Troubleshooting  After refilling paper in the external printer, press the
on the screen [Retry] button to clear the error, and the data under
printing will be printed from the beginning by one
sample.
 Press the [Cancel] button to cancel the data under
printing, also discard the waiting data, and the error is
cleared.
Note Analysis is ready when the error is cleared.
Revised January 2017

13-20 Sysmex XP-300


Troubleshooting

Error Message GP Buffer Full (443040)


(Error Code)
Cause Momentary power failure or sudden noise interference causes printer memory
errors.
Action Troubleshooting Press the [Back] button to clear the error. However, the data
on the screen under printing will be printed.
Note Analysis is ready when the error is cleared.

12. SNCS Errors

Error Message SNCS Comm. Error (487010)


(Error Code) SNCS Connection Error (487012)
SNCS Setting Error (487013)
Cause An error related to transmissions to the SNCS server has occurred.
Action  Check if the communications equipment power is turned ON
 Check if the connection cable of the communications equipment is connected
properly.
 Contact your local Sysmex service representative.
Troubleshooting  Press the [Retry] button to clear the error and the
on the screen transmission to the SNCS server will resume.
 Press the [Cancel] button to clear the error and discard
the data that is output to the SNCS server.
Note Analysis is ready when the error is cleared.

Error Message SNCS Status Error (487011)


(Error Code)
Cause An error related to transmissions to the SNCS server has occurred.
Action  Turn OFF then ON the power again.
 Contact your local Sysmex service representative.
Note Although the system is ready for analysis, no transmissions to the SNCS server is
available.
Revised January 2017

Sysmex XP-300 13-21


Troubleshooting

13.4 Print error log


An overview of the latest 10 error messages can be printed out on the
internal printer.

Note:
Have the error messages printed out before contacting your
Sysmex service representative.

(1) Press the [Menu] button on the Main screen.


The Menu screen will appear.

(2) Press the [Maint.] button.


The maintenance menu screen will appear.

(3) Select the [Print Error Log] button.


The internal printer will print out the error history.

Note:
An error subcode may be printed after the error code.
The subcode is for Sysmex service representative use only.
Revised January 2017

13-22 Sysmex XP-300


Technical Information

14. Technical Information

14.1 Specifications

Operating Ambient temperature: 15°C to 30°C (same for the supplied reagent temperature)
Environment Relative humidity: 30% to 85%
Atmospheric pressure: 70 - 106 kPa
Operating altitude: Maximum 3,000 m
Contamination Level 2
Impulse Resistance II
(Excess voltage)
category
Usage location Indoor usage only
Storage Ambient temperature: -10°C to +60°C
(transportation) Relative humidity: 30% to 95% (non condensation/keep dry)
condition
Atmospheric pressure: 70 - 106 kPa
Analysis parameters WBC (Number of leukocytes), RBC (Number of erythrocytes),
HGB (Hemoglobin), HCT (Hematocrit value), MCV (Mean RBC volume),
MCH (Mean RBC hemoglobin), MCHC (Mean RBC hemoglobin concentration),
PLT (Platelet), RDW-SD (RBC distribution width - SD),
RDW-CV (RBC distribution width - CV), PDW (Platelet distribution width),
MPV (Mean platelet volume), P-LCR (Large platelet ratio), PCT (Plateletcrit),
LYM% (W-SCR), MXD% (W-MCR), NEUT% (W-LCR), LYM# (W-SCC),
MXD# (W-MCC), NEUT# (W-LCC)
Display range WBC 0.0 - 299.9 × 103/µL
RBC 0.00 - 19.99 × 106/µL
HGB 0 - 25.0 g/dL
PLT 0 - 1999 × 103/µL
Analysis range WBC 1.0 - 99.9 × 103/µL
RBC 0.3 - 7.0 × 106/µL
HGB 0.1 - 25.0 g/dL
HCT 10.0 - 60.0 %
PLT 10.0 - 999 × 103/µL
Background limits WBC 0.3 × 103/µL or less
RBC 0.02 × 106/µL or less
HGB 0.1 g/dL or less
PLT 10 × 103/µL or less
Revised January 2017

Reagent Diluent: CELLPACK


WBC/HGB lyse reagent: STROMATOLYSER-WH
Detergent CELLCLEAN

Sysmex XP-300 14-1


Technical Information

Control material EIGHTCHECK-3WP


Consumption of Diluent WBC/HGB lyse reagent Detergent
reagent (per sample) (CELLPACK) (STROMATOLYSER-WH) (CELLCLEAN)
During (Whole blood mode) Approx. 34 mL Approx. 1 mL –
analysis
(Pre-diluted mode) Approx. 34 mL Approx. 1 mL –
During start (when the background Approx. 86 mL Approx. 3 mL –
up check is performed once)
(when the background Approx. 154 mL Approx. 5 mL –
check is performed
three times)
During (when the background Approx. 85 mL Approx. 2 mL –
Auto Rinse check is performed once)
(when the background Approx. 153 mL Approx. 4 mL –
check is performed
three times)
During Shutdown Approx. 86 mL – Approx. 0.3 mL
Throughput Approx. 60 samples/hour
Data storage Up to 40,000 with histogram
Quality control 60 plots × 6 files
Required sample WB mode Approx. 50 µL
volume PD mode Approx. 20 µL
Blood volume Whole blood mode: Approx. 50 µL
aspirated Pre-diluted mode: Approx. 200 µL (Diluted blood sample)
Blood volume required for the pre-dilution is 20 µL or over.
Analysis principle WBC: DC detection method
RBC/PLT: DC detection method
HGB: Non-cyanide hemoglobin analysis method
Revised January 2017

14-2 Sysmex XP-300


Technical Information

Precision Values are indicated as variation coefficient (with 95% reliability limit) when
(repeatability): peripheral blood or control blood is analyzed more than 10 times continuously.
Whole blood mode WBC 3.5% or less (4.0 × 103/µL or more)
RBC 2.0% or less (4.00 × 106/µL or more)
HGB 1.5% or less
HCT 2.0% or less
MCV 2.0% or less
MCH 2.0% or less
MCHC 2.0% or less
PLT 6.0% or less (100 × 103/µL or more)
LYM% 15.0% or less
MXD% 30.0% or less (12 W-MCR% or more)
NEUT% 15.0% or less
LYM# 15.0% or less
MXD# 30.0% or less (1.0 × 103/µL or more)
NEUT# 15.0% or less
RDW-CV 4.0% or less
RDW-SD 4.0% or less
PDW 12.0% or less
MPV 5.0% or less
P-LCR 20.0% or less
PCT 9.0% or less
Revised January 2017

Sysmex XP-300 14-3


Technical Information

Precision Values are indicated as variation coefficient (with 95% reliability limit) when
(repeatability): peripheral blood or control blood is analyzed more than 10 times continuously.
Pre-diluted mode WBC 6.0% or less (4.0 × 103/µL or more)
RBC 3.0% or less (4.00 × 106/µL or more)
HGB 2.5% or less
HCT 3.0% or less
MCV 3.0% or less
MCH 3.0% or less
MCHC 3.0% or less
PLT 9.0% or less (100 × 103/µL or more)
LYM% 25.0% or less
MXD% 45.0% or less (12 W-MCR% or more)
NEUT% 25.0% or less
LYM# 25.0% or less
MXD# 45.0% or less (1.0 × 103/µL or more)
NEUT# 25.0% or less
RDW-CV 6.0% or less
RDW-SD 6.0% or less
PDW 18.0% or less
MPV 7.5% or less
P-LCR 30.0% or less
PCT 13.5% or less
Accuracy: Mean values when calibrator is analyzed more than 10 times continuously are
Whole blood mode within the following ranges against the displayed values.
WBC ±3% or ±0.2 × 103/µL
RBC ±2% or ±0.03 × 106/µL
PLT ±5% or ±10 × 103/µL
Accuracy: Mean values when calibrator is analyzed more than 10 times continuously are
Pre-diluted mode within the following ranges against the displayed values.
WBC ±5% or ±0.3 × 103/µL
RBC ±3% or ±0.05 × 106/µL
PLT ±8% or ±15 × 103/µL
Revised January 2017

14-4 Sysmex XP-300


Technical Information

Linearity: The residual or residual rate against the values analyzed in whole blood mode is
Whole blood mode shown.
WBC ±0.3 × 103/µL (1.0 - 9.9 × 103/µL)
±3% (10.0 - 99.9 × 103/µL)
RBC ±0.03 × 106/µL (0.3 - 0.99 × 106/µL)
±3% (1.00 - 7.00 × 106/µL)
HGB ±0.2 g/dL (0.1 - 9.9 g/dL)
±2% (10.0 - 25.0 g/dL)
HCT ±1.0HTC% (10.0 - 33.3%)
±3% (33.4 - 60.0%)
PLT ±10 × 103/µL (10 - 199 × 103/µL)
±5% (200 - 999 × 103/µL)
(However, RBC < 7.00 × 106/µL)
Carryover WBC: 3% or less
RBC: 1.5% or less
HGB: 1.5% or less
HCT: 1.5% or less
PLT: 5% or less
Power supply AC120V/230V/240V±10% (50/60Hz)*
* Refer to the instrument’s name plate for the rated voltage.
Power consumption Approx. 200 VA or less
Noise level 55 dB or less
Excludes sounds during rinse cup discharge, printer printing noise and alarm
sounds.
Heat compensation Approx. 785 BTU/h (198 kcal/h)
required
Dimensions Main Unit: 420 (W) × 355 (D) × 480 (H) mm
Weight Main Unit: Approx. 30.0 kg
Protection type Class of electric shock protection measures: Class I Equipment
Class of electric shock protection levels: Class B Equipment
EMC This equipment is in conformity to the following IEC (EN) standard.
(Electro-magnetic IEC 61326-1: 97+A1: 98 (EN 61326: 97+A1) Electrical equipment for
compatibility) measurement, control and laboratory use -EMC requirements-
- EMI (Class A)
- EMS (Minimum Immunity test requirements)
EMC Conformity IEC61326-2-6:2005
Assessment EMI:ClassA
Standards
Revised January 2017

Safety IEC61010-1: 2001, IEC61010-2-081: 2001+A1, IEC61010-2-101: 2002

Sysmex XP-300 14-5


Technical Information

Rated input/output 1) Maximum rated input/output


condition Socket for LAN : -0.5V - 7V
Socket for bar code reader : ±25V
Serial : ±25V
Socket for graphic printer : -0.5V - 7V
Socket for LAN (SNCS service) : -0.3V - 6V
2) Rated insulation: Devices with certified safety must be connected.

Revised January 2017

14-6 Sysmex XP-300


Technical Information

14.2 System limits

Possible sample interferences

WBC

If any of the following is present, the system may erroneously report a low white blood cell count.
 Leukocyte aggregation

If any of the following is present, the system may erroneously report a high white blood cell count.
 Possibility of PLT clumps
 Lyse resistant erythrocytes
 Erythrocyte aggregation (cold agglutinin)
 Cryoprotein
 Cryoglobulin
 Fibrin
 Giant platelets (platelets > 1,000,000/µL)

RBC
Where the following are present, the system may erroneously report a low red blood cell count.
 Erythrocyte aggregation (cold agglutinin)
 Microerythrocytes
 Possibility of fragmented RBCs

If any of the following is present, the system may erroneously report a high red blood cell count.
 Leukocytosis (> 100,000/µL)
 Giant platelets (platelets > 1,000,000/µL)

HGB

If any of the following is present, the system may erroneously report a high haemoglobin concentra-
tion.
 Leukocytosis (> 100,000/µL)
 Lipemia
 Abnormal protein
Revised January 2017

Sysmex XP-300 14-7


Technical Information

HCT

If any of the following is present, the system may erroneously report a low hematocrit value.
 Erythrocyte aggregation (cold agglutinin)
 Microerythrocytes
 Possibility of fragmented RBCs

If any of the following is present, the system may erroneously report a high hematocrit value.
 Leukocytosis (> 100,000/µL)
 Severe diabetes
 Uremia
 Spherocytosis

PLT

If any of the following is present, the system may erroneously report a low platelet count.
 Possibility of PLT clumps
 Pseudothrombocytopenia
 Giant platelets

If any of the following is present, the system may erroneously report a high platelet count.
 Microerythrocytes
 Possibility of fragmented RBCs
 Fragmented leukocytes
 Cryoprotein
 Cryoglobulin

Revised January 2017

14-8 Sysmex XP-300


Technical Information

14.3 Print formats


Shown are examples of printed results on the internal printer. For the setting procedures, see
“11.2 Possible settings”.

Output on internal printer (IP)

Type 1 Type 2 Type 3


Revised January 2017

Sysmex XP-300 14-9


Technical Information

Examples of printed results on the graphic printer (GP)

Revised January 2017

14-10 Sysmex XP-300


Technical Information

Examples of printed results on the list printer (LP)

Note:
A numeric value abnormal flag is printed to the right of
each value on the list printer (LP).
Revised January 2017

Sysmex XP-300 14-11


Technical Information

14.4 Connecting the bar code reader


With this instrument, the optional bar code reader scans the bar code
on the sample tube and automatically inputs the sample ID number.
The bar code reader also reads the bar code on the reagent when it is
replaced.

No. Explanation
1 Bar code reader unit

2 Desk-top holder for the bar code reader

Connection procedure
(1) Turn the main power switch OFF.
(2) Insert the other end of the connection cable into the bar code
reader connector port at the back of the instrument.
Bar code
reader
connector
port

(3) Turn the main power switch ON.


Press the trigger switch and check that the red LED is ON.
Revised January 2017

Trigger switch

14-12 Sysmex XP-300


Technical Information

Bar code reader settings

Make settings according to the menu sheet which is provided with


the bar code reader.
Communications parameters were set at the time the unit was
shipped from the factory. They do not need to be set.
Make settings to match the bar code label which you use.
Set the ID character and check digit to “Not transmit”.

Hardware specifications

(1) Symbologies which can be read: UPC-A/E, CODE39,


CODE128, ITF, NW-7
(CODABAR)
(2) Decoder: Built-in
(3) Interface: RS-232C
(4) Connector: DIN 8P
(5) Power input: 5 V DC ±5%
(6) Connector pin arrangement
No. Signal name Signal direction
1 TxD (Transmit Data) Reader  Analyzer
2 RxD (Receive Data) Reader  Analyzer
3 RTS (Request To Send) Reader  Analyzer
4 CTS (Clear To Send) Reader  Analyzer
5 NC (Not Connected)
6 DTR (Data Terminal Reader  Analyzer
Ready)
7 SG (0 V) Reader – Analyzer
8 +5 V (+5 V) Reader  Analyzer
Revised January 2017

Sysmex XP-300 14-13


Technical Information

Software specifications

(1) Data communication protocol

S E
T T
X X

Order of transmission

(2) Data transmission parameters


Parameter Setting value
Baud rate 9600 bps
Data length 8 bits
Stop bit 1 bit
Parity None
RTS/CTS Valid
Transfer sequence No protocol
Check digit Not transmit
ID character Not transmit
Preamble STX (02H)
Postamble ETX (03H)

Revised January 2017

14-14 Sysmex XP-300


Technical Information

ID Bar code specifications

When using bar code labels, labels with specifications that match the bar code reader for the XP-300
must be used.
This section explains the bar code label specifications.

Note:
Following is an explanation of the typical bar code label specifications.
The actual specifications may differ depending on the symbology, print quality, and number
of digits.
Specifications for JAN codes will also be somewhat different.
For details, contact your Sysmex service representative.

Symbologies used
The symbologies and check digits which can be used are listed below.

Warning!
If the sample bar code is used, use a check digit whenever possible.
If a check digit is not used, the chances of the bar code being misread increase.

Symbology Check digit Number of digits


ITF None Max. 14 digits (sample ID)
Modulus 10 Max. 14 digits (sample ID)
+ 1 digit (check digit) = Max. 15 digits
NW-7 None Max. 15 digits (sample ID)
Modulus 11 Max. 15 digits (sample ID)
Weighted modulus 11 + 1 digit (check digit) = Max. 16 digits
Modulus 16
CODE39 None Max. 15 digits (sample ID)
Modulus 43 Max. 15 digits (sample ID)
+ 1 digit (check digit) = Max. 16 digits
CODE128 Modulus 103 Max. 15 digits (sample ID)
+ 1 digit (check digit) = Max. 16 digits
JAN-8 Modulus 10 7 digits (sample ID)
+ 1 digit (check digit) = 8 digits
JAN-13 Modulus 10 12 digits (sample ID)
+ 1 digit (check digit) = 13 digits

Bar code element dimensions


Narrow: Min. 0.20 mm
Narrow: Wide 2.2 - 3.0
Narrow space: Narrow bar 0.85 - 1.17
Revised January 2017

Sysmex XP-300 14-15


Technical Information

PCS (Print Contrast Signal) value


Reflectivity of the space - Reflectivity of the black inked bar
PCS =
Reflectivity of the space
Standard: PCS value  0.45
The analysis method conforms to JIS (Japanese Industrial Standards) X0501, Section 5.3:
Optical Characteristics of Bar code Symbols.

Surface reflection
A laminated label cannot be read.

Irregularity and roughness of printing


Enlarging a single bar from a bar code with a microscope shows something like the figure
below.

MAX

MIN

Bar element

When the variation coefficient (S) in the width of a bar is defined:


MAX - MIN
S= × 100%
MAX
Then the variation coefficient (S) must be 20% or less.

Bar code label dimensions

Bar height

Space Effective bar code width Space

Space: Min. 2.5 mm or 10 × largest module value


Effective bar code width: Max. 48 mm (Optimum: 40 mm or less)
Bar height: Min. 20 mm
Revised January 2017

14-16 Sysmex XP-300


Technical Information

Check digit
A check digit can be added to further increase the reliability of the ID number which is read.
Following is an example of the methods used to calculate the check digit of modulus 11 and
weighted modulus 11 for a sample ID number of “258416”.

(1) Modulus 11
1) A weight is assigned to each digit.
2 5 8 4 1 6
× × × × × ×
Weight 7 6 5 4 3 2
14 30 40 16 3 12
2) The results of multiplication are all added together. The result is S.
S = 14 + 30 + 40 + 16 + 3 + 12 = 115
3) A remainder is found by dividing S by 11. The complement of this remainder is then found. The
11-complement becomes the check digit value to be added.
115 / 11 = 10 (remainder = 5)
11 - 5 = 6 The check digit is 6.
All alphabet and symbol characters other than numbers 0 to 9 are considered for calculation to
be 0. If the remainder is 0 when S is divided by 11, or if the result of check-digit calculation is
10, then the check digit is 0.

(2) Weighted modulus 11


With weighted modulus 11, there are 2 sets of weights for each digit. The check is performed
first using the first set of weights. If the result is 10, then the check is performed again using the
second set of digits. The result is assured to be 0 to 9. Except for the difference in weights, the
calculation method is exactly the same as for modulus 11.
1) Weights are assigned to each digit.
Weight: W12 W11 W10 W9 W8 W7 W6 W5 W4 W3 W2 W1
First set: 6 3 5 9 10 7 8 4 5 3 6 2
Second set: 5 8 6 2 10 4 3 7 6 8 5 9

2 5 8 4 1 6
× × × × × ×
Weight 8 4 5 3 6 2
16 20 40 12 6 12

2) The results of multiplication are all added together. The result is S.


S = 16 + 20 + 40 + 12 + 6 + 12 = 106
Revised January 2017

Sysmex XP-300 14-17


Technical Information

3) A remainder is found by dividing S by 11. The complement of this remainder is then found. The
11-complement becomes the check digit value to be added.
106 / 11 = 9 (remainder = 7)
11 - 7 = 4 The check digit is 4.
All alphabet and symbol characters other than numbers 0 to 9 are considered for calculation to
be 0. If the remainder is 0 when S is divided by 11, or if the result of check-digit calculation is 0,
then the check digit is 0.

Note:
The weight of digits 13 to 15 is 0.

Revised January 2017

14-18 Sysmex XP-300


Technical Information

14.5 System of units

Type1 (Japan) Type2 (For General Export) Type3 (Canada SI)

Item Decimal Unit Decimal Unit Decimal Unit


point point point

WBC #### × 102/L ###.# × 103/L ###.# × 109/L

RBC #### × 104/L ##.## × 106/L ##.## × 1012/L

HGB ###.# g/dL ###.# g/dL #### g/L

HCT ###.# % ###.# % #.### L/L

MCV ###.# fL ###.# fL ###.# fL

MCH ###.# pg ###.# pg ###.# pg

MCHC ###.# g/dL ###.# g/dL #### g/L

PLT ###.# × 104/L #### × 103/L #### × 109/L

LYM% ###.# % ###.# % #.###

MXD% ###.# % ###.# % #.###

NEUT% ###.# % ###.# % #.###

LYM# #### × 102/L ###.# × 103/L ###.# × 109/L

MXD# #### × 102/L ###.# × 103/L ###.# × 109/L

NEUT# #### × 102/L ###.# × 103/L ###.# × 109/L

RDW-SD ###.# fL ###.# fL ###.# fL

RDW-CV ###.# % ###.# % #.###

MPV ###.# fL ###.# fL ###.# fL

PDW ###.# fL ###.# fL ###.# fL

P-LCR ###.# % ###.# % #.###

PCT ##.## % ##.## % #.####

ResearchW ####.## × 102/L ###.### × 103/L ###.### × 109/L


ResearchS
ResearchM
ResearchL
Revised January 2017

Sysmex XP-300 14-19


Technical Information

Type4 (Dutch SI) Type5 (Standard SI) Type6 (Hong Kong SI)

Item Decimal Unit Decimal Unit Decimal Unit


point point point

WBC ###.# × 109/L ###.# × 109/L ###.# × 109/L

RBC ##.## × 1012/L ##.## × 1012/L ##.## × 1012/L

HGB ###.# mmol/L #### g/L ###.# g/dL

HCT #.### L/L #.### #.###

MCV ###.# fL ###.# fL ###.# fL

MCH #### amol ###.# pg ###.# pg

MCHC ###.# mmol/L #### g/L ###.# g/dL

PLT #### × 109/L #### × 109/L #### × 109/L

LYM% #.### #.### ###.# %

MXD% #.### #.### ###.# %

NEUT% #.### #.### ###.# %

LYM# ###.# × 109/L ###.# × 109/L ###.# × 109/L

MXD# ###.# × 109/L ###.# × 109/L ###.# × 109/L

NEUT# ###.# × 109/L ###.# × 109/L ###.# × 109/L

RDW-SD ###.# fL ###.# fL ###.# fL

RDW-CV #.### #.### ###.# %

MPV ###.# fL ###.# fL ###.# fL

PDW ###.# fL ###.# fL ###.# fL

P-LCR #.### #.### ###.# %

PCT #.#### #.#### ##.## %

ResearchW ###.### × 109/L ###.### × 109/L ###.### × 109/L


ResearchS
ResearchM
ResearchL
Revised January 2017

14-20 Sysmex XP-300


Technical Information

14.6 Functional description


This chapter describes blood cell count detection principle and analysis method used in this
instrument, and flow of individual analysis. Also the hardware elements are explained.

 Detection principle: Principle each of DC detection method and non-cyanide


hemoglobin analysis method is described.

 Flow of analysis: Flow of each analysis parameter on the main unit and analysis
method for particle distribution are described.

Detection principle
This instrument performs blood cell count by DC detection method.

DC detection method
Blood sample is aspirated, measured to a predetermined volume, diluted at the specified ratio, then
fed into each transducer.
The TD chamber has a minute hole called the aperture. On both sides of the aperture, there are the
electrodes between which flows direct current. Blood cells suspended in the diluted sample pass
through the aperture, causing direct current resistance to change between the electrodes. As direct
current resistance changes, the blood cell size is detected as electric pulses.
Blood cell count is calculated by counting the pulses, and a histogram of blood cell sizes is plotted by
determining the pulse sizes. Also, analyzing a histogram makes it possible to obtain various analysis
data.

DC

DC Supply

TD Chamber

Resistance
External Electrode +

Blood Cell Suspension

Aperture Internal Electrode -


Revised January 2017

Sysmex XP-300 14-21


Technical Information

Non-cyanide hemoglobin analysis method

To analyze hemoglobin by automated methods, the Cyanmethemoglobin method or Oxyhemoglobin


method have so far been the main stream.
Cyanmethemoglobin method was recommended as the international standard method in 1966 by
ICSH (International Committee for Standardization in Hematology). This method, however, is so low
in hemoglobin conversion rate that it cannot be said an appropriate method in the automated process
in which multi-sample processing is the pre-condition. In addition, this method uses the reagent of
cyanide compound which is a poisonous substance and requires waste processing; thus, it can hardly
be called an environmentally favorable method.
At present, this method cannot be said suitable for a fully-automated instrument which is required to
handle a large amount of waste.
The Oxyhemoglobin method, on the other hand, is faster in hemoglobin conversion rate; in fact,
blood hemoglobin is converted instantaneously into oxyhemoglobin. Also, it does not contain
poisonous substance as cyanmethemoglobin method, making the method suitable for automation.
This method, however, is unable to convert methemoglobin into oxyhemoglobin. Consequently,
when a great amount of methemoglobin is contained as in control blood, lower-than-real values
result, although usual human blood poses no problems.
Non-cyanide hemoglobin analysis method utilizes the advantages of both of the above methods. Non-
cyanide hemoglobin analysis method rapidly converts blood hemoglobin as the Oxyhemoglobin
method and contains no poisonous substance, making it suitable for automated method.
Being capable of analyzing methemoglobin, this method can accurately analyze control blood, etc.
which contain methemoglobin.

Revised January 2017

14-22 Sysmex XP-300


Technical Information

Measuring unit hydraulic system block diagram

<Whole Blood Mode>

1.960 mL

Diluent 1.996 mL RBC TD Chamber

Mixing Chamber 40 µL (1:25,000)

4.0 µL (1:500)
1.994 mL
1.0 mL WBC TD Chamber
WBC/HGB Lyse

SRV 6 µL (1:500)

HGB Flow Cell

(1:500)

Whole Blood Sample (50 µL)

<Pre-diluted Mode>

1.99792 mL

Diluent RBC TD Chamber

2.08 µL (1:25,000)

1.922 mL
1.0 mL WBC TD Chamber
WBC/HGB Lyse

78 µL (1:1,000)
SRV

HGB Flow Cell

(1:1,000)

1:26 Diluted Sample (200 µL)


Revised January 2017

Sysmex XP-300 14-23


Technical Information

CBC analysis

WBC/HGB analysis flow

In WBC and HGB analysis, the volume of WBC and hemoglobin in the blood are measured. The flow
of WBC/HGB analysis is described below:

Diluent: 2.0 mL WBC/HGB Lyse:


Whole Blood Mode 1.0 mL
Pre-diluted Mode 1.0 mL

SRV

Whole Blood Mode 1 mL


Pre-diluted Mode 1 mL

HGB Flow Cell


Whole Blood Mode: Diluent 1.994 mL
Whole Blood 6 µL
Pre-diluted Mode: Diluent 1.922 mL
1:26 Diluted Sample 78 µL

WBC Transducer
Tube or Micro tube
Whole Blood Mode: 50 µL
Pre-diluted Mode: 1:26 Diluted Sample 200 µL

• Whole Blood Mode


(1) Blood is aspirated from the sample probe into the SRV.
(2) 6 µL of blood measured by the SRV is transferred to the WBC TD chamber along with 1.994
mL of diluent. At the same time, 1.0 mL of WBC/HGB lyse is added to prepare 1:500 dilution
sample.
When the solution is made to react in this status for approximately 10 seconds, RBC is
hemolyzed and platelets shrink, with WBC membrane held as they are. At the same time,
hemoglobin is converted into red colored methemoglobin.
(3) Of the diluted/hemolyzed sample in the WBC TD chamber, approximately 1 mL is transferred
to the HGB flow cell.
(4) 500 µL of sample in the WBC transducer is aspirated through the aperture. The pulses of the
blood cells when passing through the aperture are counted by the DC detection method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting diode (LED)
is applied to the sample in the HGB flow cell. Concentration of this sample is measured as
absorbance. This absorbance is compared with that of the diluent alone that was measured
before addition of the sample, thereby calculating HGB (hemoglobin value).
Revised January 2017

14-24 Sysmex XP-300


Technical Information

• Pre-diluted Mode
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This sample is
aspirated from the sample probe into the SRV.
(2) 78 µL of diluted blood measured by the SRV is transferred to the WBC TD chamber along with
1.922 mL of diluent. At this time, 1.0 mL of WBC/HGB lyse is added to prepare 1:1,000
dilution sample.
When the solution is made to react in this status for approximately 10 seconds, RBC is
hemolyzed and platelets shrink, with WBC membrane held as they are. At the same time,
hemoglobin is converted into red colored methemoglobin.
(3) Of the diluted/hemolyzed sample in the WBC TD chamber, approximately 1 mL is transferred
to the HGB flow cell.
(4) 500 µL of sample in the WBC TD chamber is aspirated through the aperture. The pulses of the
blood cells when passing through the aperture are counted by the DC detection method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting diode (LED)
is applied to the sample in the HGB flow cell. Concentration of this sample is measured as
absorbance. This absorbance is compared with that of the diluent alone that was measured
before addition of the sample, thereby calculating HGB (hemoglobin value).
Revised January 2017

Sysmex XP-300 14-25


Technical Information

RBC/PLT analysis flow

In RBC/PLT analysis, RBC and platelet count in the blood are measured. The flow of RBC/PLT
analysis is described below:

• Whole Blood Mode

Diluent: 2.0 mL Diluent 1.996 mL


Whole Blood 4 µL

SRV Diluent 1.960 mL


1:500 Diluted Sample 40 µL

RBC/PLT Transducer

(1:500 Diluted Sample: 40 µL)


Tube
(Whole Blood: 50 µL) Mixing Chamber

(1) Blood is aspirated from the sample probe into the SRV.
(2) 4.0 µL of blood measured by the SRV is diluted into 1:500 with 1.996 mL of diluent and brought
to the mixing chamber as diluted sample. (1st step dilution)
(3) Out of the 1:500 dilution sample, 40 µL is measured by the SRV, diluted into 1:25,000 with
1.960 mL of diluent, then transferred to the RBC/PLT TD chamber. (2nd step dilution)
(4) 250 µL of the sample in the RBC/PLT TD chamber is aspirated through the aperture. At this
time, RBC and PLT are counted by the DC detection method.
At the same time, HCT (hematocrit value) is calculated by RBC pulse height detection method.
Revised January 2017

14-26 Sysmex XP-300


Technical Information

• Pre-diluted Mode

Diluent: 2.0 mL Diluent 1.99792 mL


1:26 Diluted Sample 2.08 µL

SRV

Microtube RBC/PLT Transducer


(1:26 Diluted Sample: 200 µL)

(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This sample is
aspirated from the sample probe into the SRV.
(2) 2.08 µL of diluted blood measured by the SRV is transferred in 1.99792 mL of diluent to the
RBC/PLT TD chamber, and is made into 1:25,000 dilution sample.
(3) Of the sample in the RBC/PLT TD chamber, 250 µL is aspirated through the aperture. At this
time, RBC and PLT are calculated by the DC detection method.
At the same time, HCT (hematocrit value) is calculated by RBC pulse height detection method.
Revised January 2017

Sysmex XP-300 14-27


Technical Information

Calculation of RBC constant

RBC constant (mean RBC volume, mean RBC hemoglobin, mean RBC hemoglobin concentration) is
calculated from RBC, HGB, and HCT.

1. Mean RBC Volume (MCV)


Calculation is made from RBC and HCT by the formula below:

HCT (%)
MCV (fL) = 6 ×10
RBC (×10 /µL)

2. Mean RBC Hemoglobin (MCH)


Calculation is made from RBC and HGB by the formula below:

HGB (g/dL)
MCH (pg) = 6 ×10
RBC (×10 /µL)

3. Mean RBC Hemoglobin Concentration (MCHC)


Calculation is made from HCT and HGB by the formula below:

HGB (g/dL)
MCHC (g/dL) = ×100
HCT (%)

Revised January 2017

14-28 Sysmex XP-300


Technical Information

Blood cell discrimination circuit

WBC, RBC, and PLT are discriminated and calculated by the following blood cell discriminator.

WBC discriminator

As to WBC LOWER discriminator and UPPER discriminator, the optimum position in 30 - 60 fL and
300 fL, respectively, are automatically determined by the microcomputer. WBC is calculated from
the particle counts between this LOWER discriminator and UPPER discriminator.

RBC discriminator

As to RBC LOWER discriminator and UPPER discriminator, the optimum position in 25 - 75 fL and
200 - 250 fL, respectively, are automatically determined by the microcomputer. RBC is calculated
from the particle counts between this LOWER discriminator and UPPER discriminator.

PLT discriminator

As to PLT LOWER discriminator and UPPER discriminator, the optimum position in 2 - 6 fL and 12
- 30 fL, respectively, are automatically determined by the microcomputer. PLT count is calculated
from the particle counts between this LOWER discriminator and UPPER discriminator.
Revised January 2017

Sysmex XP-300 14-29


Technical Information

Analysis of histogram

Analysis of histogram allows use of the flagging system that suggests sample error or instrument
error.

Histograms of WBC, RBC, and PLT can be calculated respectively within the ranges given below.

WBC: Approx. 30 - 300 fL (particle after lyse dripping)


RBC: Approx. 25 - 250 fL
PLT: Approx. 2 - 30 fL

Analysis of WBC histogram

1. WBC Histogram

The WBC histogram is discriminated into small, middle, and large WBC by 3-part differential
method using 4 discriminators. The LOWER discriminator (LD) is automatically determined at an
optimum position between 30 and 60 fL. The UPPER discriminator (UD) is fixed at 300 fL, which is
used as the monitor for histogram error. The WBC histogram troughs in the (LD)-to-(UD) range are
determined; the 1st one is defined TROUGH Discriminator 1 (T1) and the 2nd one TROUGH
Discriminator 2 (T2).

• WBC Histogram

LD T1 T2 UD
WBC

100 200 300 [fL]


Lymphocytes Mixed cells Neutrophils

1) LYM# [W-SCC (WBC-Small Cell Count)]


Lymphocytes between discriminator (LD) and (T1), which is considered highly correlated with
lymphocyte count.

2) MXD# [W-MCC (WBC-Middle Cell Count)]


Mixed cells between discriminator (T1) and (T2), which is considered highly correlated with the
sum of monocytes, basophils, and eosinophils.

3) NEUT# [W-LCC (WBC-Large Cell Count)]


Neutrophils more than discriminator (T2), which is considered highly correlated with
neutrophils.

4) LYM% [W-SCR (WBC-Small Cell Ratio)]


Ratio of lymphocytes to whole WBC
Revised January 2017

5) MXD% [W-MCR (WBC-Middle Cell Ratio)]


Ratio of mixed cells to whole WBC

14-30 Sysmex XP-300


Technical Information

6) NEUT% [W-LCR (WBC-Large Cell Ratio)]


Ratio of neutrophils to whole WBC

2. WBC research parameters

Caution!
WBC research parameters are for research purposes only.
Do not use analysis results for WBC research parameters in patient diagnosis.

Each parameter shows the following particle counts contained in 1 µL of whole blood.
 ResearchW: Particle counts between LD and UD of the WBC histogram
 ResearchS: Particle counts between LD and T1 of the WBC histogram
 ResearchM: Particle counts between T1 and T2 of the WBC histogram
 ResearchL: Particle counts between T2 and UD of the WBC histogram

• Analysis result display screen


Analysis results are displayed on the fourth analysis result screen and fourth stored data detail screen.

• Print format
ResearchS, ResearchM, ResearchL: Can be printed in Type1 or Type2.
ResearchW: Can be printed in Type1, Type2 or Type3.

• Interface protocol
ResearchS, ResearchM, ResearchL: Can be output to the host computer in XP format.
ResearchW: Can be output to the host computer in XP format or pocH format.
For details, contact your local Sysmex service representative.
Revised January 2017

Sysmex XP-300 14-31


Technical Information

3. WBC Histogram Error Flag

When the WBC histogram is normal with 3 peaks, there are a lower trough (T1) and a higher trough
(T2) between LOWER discriminator (LD) and UPPER discriminator (UD).

• Output Example of Normal WBC Three-Peak Histogram

LD T1 T2 UD
WBC 6.7 [×103/µL]
WBC
LYM% 28.3 [%]
MXD% 17.4 [%]
NEUT% 54.3 [%]
LYM# 1.9 [×103/µL]
100 200 300 [fL] MXD# 1.2 [×103/µL]
NEUT# 3.6 [×103/µL]

When TROUGH Discriminator (T1) or (T2) cannot be set or when frequency for a set discriminator
position is higher than the range, it is flagged as WBC histogram error. Those histogram error flags
are listed below in the order of higher priority. If more than one flag is applied, the flag of the highest
priority is taken.

WL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is
inclusion of numerous platelet agglutinations, large platelets, and etc.

T1: Lower TROUGH Discriminator, that distinguishes lymphocytes and mixed cells, cannot be not
determined.

T2: Higher TROUGH Discriminator, that distinguishes mixed cells and neutrophils, cannot be not
determined.

F1: Small cell histogram error. Relative frequency for T1 exceeds the range.

F2: Middle cell histogram error. Relative frequency for T1 or T2 exceeds the range.

F3: Large cell histogram error. Relative frequency for T2 exceeds the range.

WU: Relative frequency for UPPER discriminator (UD) exceeds the range. Applicable case is that in
which considerable leukocyte aggregation or numerous abnormal blood cells are present.

AG: The particle count equal to or less than the LD exceeds a prescribed range. Probable cause is
platelet agglutination, which does not alter WBC count but may result in decreased platelet
count. Therefore, this flag is added to the PLT parameter.
Revised January 2017

14-32 Sysmex XP-300


Technical Information

• WBC and calculation parameters versus analysis value error flags

WBC Histogram Error Flag Output


[1] [2]
Case
LD T1 T2 UD WBC LYM% MXD% NEUT% LYM# MXD# NEUT# HOST
No.
1 High WL WL WL WL WL WL WL 1
2A  ×  T1 T1 T1 T1 T1 T1 5
2B  × High WU T1 T1 T1 T1 T1 T1 5
3A  High ×  F1 T2 T2 F1 T2 T2 6
3B  High × High WU F1 T2 T2 F1 T2 T2 6
3C   ×  T2 T2 T2 T2 6
3D   × High WU T2 T2 T2 T2 6
4A  High   F1 F2 F1 F2 7
4B  High  High WU F1 F2 F1 F2 7
4C  High High  F1 F2 F3 F1 F2 F3 7
4D  High High High WU F1 F2 F3 F1 F2 F3 7
5A   High  F2 F3 F2 F3 8
5B   High High WU F2 F3 F2 F3 8
6    High WU 2
7 (The particle count equal to or PLT parameter is flagged with AG. A
less than LD is higher than the
range)
[1]: Output flag to LCD screen, printer.
[2]: Output flag to host computer.
: Analysis result of each discriminator is normal.
High: Frequency for each discriminator is higher than the range.
×: A trough is not clear and cannot be detected.
: Any of “,” “×,” and “High” is applicable.

1) 1A Histogram having high LD frequency with troughs T1 and T2


WL flag is added to all WBC parameters (WBC, LYM%, MXD%, NEUT%, LYM#, MXD#,
NEUT#).

• WBC Histogram Error-WL (1A)

LD T1 T2 UD
WBC WL 8.5 [×103/µL]
WBC
LYM% WL 39.3 [%]
MXD% WL 17.6 [%]
NEUT% WL 43.1 [%]
LYM# WL 3.4 [×103/µL]
100 200 300 [fL] MXD# WL 1.5 [×103/µL]
Revised January 2017

NEUT# WL 3.6 [×103/µL]

Sysmex XP-300 14-33


Technical Information

2) 1B Histogram with high LD and trough T1 but without T2


WL flag is added to all analysis results for WBC, LYM% and LYM#. WL flag is added to mixed
cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) and their data are not
output.
([---.-])

• WBC Histogram Error-WL (1B)

LD T1 UD
WBC WL 2.8 [×103/µL]
WBC
LYM% WL 45.9 [%]
MXD% WL ---.- [%]
NEUT% WL ---.- [%]
LYM# WL 1.3 [×103/µL]
100 200 300 [fL] MXD# WL ---.- [×103/µL]
NEUT# WL ---.- [×103/µL]

3) 1C Histogram with high LD but without T1


WL flag is added to WBC and other parameters are not output. Note [+] on WBC numeric data
in the example below. This WBC value exceeds the upper Patient Mark Limits mentioned
earlier.

• WBC Histogram Error-WL (1C)

LD UD
WBC WL +16.4 [×103/µL]
WBC
LYM% WL ---.- [%]
MXD% WL ---.- [%]
NEUT% WL ---.- [%]
LYM# WL ---.- [×103/µL]
100 200 300 [fL] MXD# WL ---.- [×103/µL]
NEUT# WL ---.- [×103/µL]
Revised January 2017

14-34 Sysmex XP-300


Technical Information

4) 2A Histogram without T1
Although the histogram error flag is not added to WBC, all other parameters are flagged with T1
and their data are not output. Note that WBC in the graph exceeds the upper Patient Mark
Limits.

• WBC Histogram Error-T1 (2A)

LD UD
WBC +15.4 [×103/µL]
WBC
LYM% T1 ---.- [%]
MXD% T1 ---.- [%]
NEUT% T1 ---.- [%]
LYM# T1 ---.- [×103/µL]
100 200 300 [fL] MXD# T1 ---.- [×103/µL]
NEUT# T1 ---.- [×103/µL]

5) 2B Histogram having high UD but without T1


WBC is flagged with WU. All other parameters are flagged with T1 and their data are not
output.

6) 3A Histogram with high T1 but without T2


WBC is not flagged. F1 flag is added to lymphocyte parameters (LYM%, LYM#). Mixed cell
and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) are flagged with T2 and their
data are not output.

• WBC Histogram Error-T2 (3A)

LD T1 UD
WBC 5.2 [×103/µL]
WBC
LYM% F1 29.7 [%]
MXD% T2 ---.- [%]
NEUT% T2 ---.- [%]
LYM# F1 1.5 [×103/µL]
100 200 300 [fL] MXD# T2 ---.- [×103/µL]
NEUT# T2 ---.- [×103/µL]

7) 3B Histogram with high T1 but without T2, and high in UD frequency


WBC is flagged with WU and lymphocyte parameters (LYM%, LYM#) are flagged with F1.
Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) are flagged with T2
and their data are not output.
Revised January 2017

Sysmex XP-300 14-35


Technical Information

8) 3C Histogram with T1 but without T2


WBC and lymphocyte parameters (LYM%, LYM#) are not flagged as the histogram error.
Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) are flagged with T2
and data are not output.
WBC shown below exceeds the upper Patient Mark Limits.

• WBC Histogram Error-T2 (3C)

LD T1 UD
WBC +15.2 [×103/µL]
WBC
LYM% 12.9 [%]
MXD% T2 ---.- [%]
NEUT% T2 ---.- [%]
LYM# 1.6 [×103/µL]
100 200 300 [fL] MXD# T2 ---.- [×103/µL]
NEUT# T2 ---.- [×103/µL]

9) 3D Histogram with high T1 but no T2, and with high UD


WBC is flagged with WU. Lymphocyte parameters (LYM%, LYM#) are not flagged. Mixed
cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) are flagged with T2 and
their data are not output.

10) 4A Histogram with high T1


WBC and neutrophil parameters (NEUT%, NEUT#) are not flagged. Lymphocyte parameters
(LYM%, LYM#) are flagged with F1 and mixed cell parameters (MXD%, MXD#) are flagged
with F2.

• WBC Histogram Error - F1 (4A)

LD T1 T2 UD
WBC 6.7 [×103/µL]
WBC
LYM% F1 28.3 [%]
MXD% F2 17.4 [%]
NEUT% 54.3 [%]
LYM# F1 1.9 [×103/µL]
100 200 300 [fL] MXD# F2 1.2 [×103/µL]
NEUT# 3.6 [×103/µL]

11) 4B Histogram with high T1 and UD


WBC is flagged with WU, lymphocyte parameters (LYM%, LYM#) are flagged with F1, and
mixed cell parameters (MXD%, MXD#) with F2. Neutrophil parameters (NEUT%, NEUT#) are
not flagged.
Revised January 2017

14-36 Sysmex XP-300


Technical Information

12) 4C Histogram with high T1 and high T2


WBC is not flagged. Lymphocyte parameters (LYM%, LYM#) are flagged with F1, mixed cell
parameters (MXD%, MXD#) with F2, and neutrophil parameters (NEUT%, NEUT#) with F3.

• WBC Histogram Error - F1 (4C)

LD T1 T2 UD
WBC 10.7 [×103/µL]
WBC
LYM% F1 20.8 [%]
MXD% F2 11.2 [%]
NEUT% F3 68.0 [%]
LYM# F1 2.2 [×103/µL]
100 200 300 [fL] MXD# F2 1.2 [×103/µL]
NEUT# F3 7.3 [×103/µL]

13) 4D Histogram high in all T1, T2, and UD


WBC data are output with WU flag, lymphocyte parameters (LYM%, LYM#) with F1 flag,
mixed cell parameters (MXD%, MXD#) with F2 flag, and neutrophil parameters (NEUT%,
NEUT#) with F3 flag.

14) 5A Histogram with high T2


Histogram error flag is not added to WBC and lymphocyte parameters (LYM%, LYM#). Mixed
cell parameters (MXD%, MXD#) are flagged with F2, and neutrophil parameters (NEUT%,
NEUT#) with F3 flag. WBC and MXD% exceed the upper Patient Mark Limits.

• WBC Histogram Error - F2 (5A)

LD T1 T2 UD
WBC + 18.5 [×103/µL]
WBC
LYM% 9.5 [%]
MXD% F2 + 23.7 [%]
NEUT% F3 66.8 [%]
LYM# 1.1 [×103/µL]
100 200 300 [fL] MXD# F2 2.7 [×103/µL]
NEUT# F3 7.7 [×103/µL]

15) 5B Histogram with high T2 and high UD


WBC is flagged with WU and lymphocyte parameters (LYM%, LYM#) are not flagged. Mixed
cell parameters (MXD%, MXD#) are flagged with F2, and neutrophil parameters (NEUT%,
NEUT#) with F3.
Revised January 2017

Sysmex XP-300 14-37


Technical Information

16) 6 Histogram with high UD


WBC is flagged with WU and other parameters are not flagged. WBC in this instance exceeds
the upper Patient Mark Limits.

• WBC Histogram Error - WU (6)

LD T1 T2 UD
WBC WU + 15.4 [×103/µL]
WBC
LYM% 24.5 [%]
MXD% 7.5 [%]
NEUT% 68 [%]
LYM# 3.3 [×103/µL]
100 200 300 [fL] MXD# 1.0 [×103/µL]
NEUT# 8.1 [×103/µL]

17) 7 The particle count equal to or less than LD is higher than the range.
PLT is flagged with AG and other parameters are not flagged.

Revised January 2017

14-38 Sysmex XP-300


Technical Information

Analysis of RBC/PLT histogram

1. RBC Histogram

As mentioned earlier, RBC are determined as particle counts between 2 discriminators (LD) and
(UD) which are automatically counted in the ranges of 25 - 75 fL and 200 - 250 fL, respectively. As
to histogram, check is made for relative frequency errors on respective discriminator levels, for more
than one peak, and for distribution width error.

In addition, this instrument is capable of expressing RBC distribution width (RDW) by 2 methods
below:

RDW-CV (RBC Distribution Width - Coefficient of Variation) is calculated by the formula below,
after determining points L1 and L2 for 68.26% of the entire particle area. The unit applied is %.

• Calculation of RDW-CV

L2–L1
RDW-CV(%) = ×100
L2+L1

68.26% of Entire Distribution Area

L1 L2

RDW-SD (RBC Distribution Width - SD) is set on 20% frequency level with the peak taken as 100%.
The unit applied is fL (femto-liter = 10-15L).

• Definition of RDW-SD

100%

20%

RDW-SD
Revised January 2017

Sysmex XP-300 14-39


Technical Information

2. PLT Histogram

Platelet histogram is analyzed using 3 discriminators: 2 discriminators (LD) and (UD) - determined
automatically between 2 - 6 fL and between 12 - 30 fL, respectively -and the fixed discriminator at 12
fL. Regarding PLT histogram, check is made to see that there are no relative frequency errors at
discriminators (LD) and (UD), distribution width error, and there is a single peak.

1) PDW (PLT Distribution Width)


PDW is the distribution width on 20% frequency level with the peak taken as 100%. The unit
applied is fL (femto-liter = 10-15L).

• Definitions of PDW and P-LCR

100% P-LCR

20%

(LD) (12fL) (UD)


PDW

2) MPV (Mean Platelet Volume)


MPV is calculated by the following formula:

PCT(%)
MPV(fL) = ×10,000
PLT(×103/µL)

Where PCT (%) represents the value weighted with PLT frequency and is called plateletcrit or
platelet volume ratio. The analysis method used is the same as mentioned in HCT analysis principle
“RBC/PLT analysis flow” in “CBC analysis”.

3) P-LCR (Large Platelet Ratio)


This is the ratio of large platelets exceeding 12 fL discriminator and is calculated as the ratio of
the particle count between the 12-fL fixed discriminator and Upper discriminator (UD) to the
particle count between Lower discriminator (LD) and Upper discriminator (UD).
Revised January 2017

14-40 Sysmex XP-300


Technical Information

3. RBC Histogram Error Flag

When RBC histogram is not normal, a histogram error flag is added to the corresponding parameter
of the analysis value. Those histogram error flags are listed in the order of higher priority.
When 2 or more flags are applicable to a parameter, the highest-priority flag is used.

RL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is the
effect of noise, RBC morphological change, platelet coagulation, or the like.

RU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable cause is the
effect of noise.

MP: 2 or more peaks in histogram.

DW: Particle distribution width error for 20% frequency with the peak taken as 100%. When the
20% frequency does not cross the histogram 2 times, this flag is attached.

• Matching of 8 kinds of RBC histogram error flags

RBC Histogram Error Flag Output


[1] [2]
Case RDW RDW
LD UD DW MP RBC HCT MCV MCH MCHC PLT HOST
No. -SD -CV
1A High   RL RL RL RL RL RL RL RL 1
1B High ×  RL RL RL RL RL RL DW RL 1
1C High × RL RL RL RL RL RL MP MP 1
2A  High   RU RU RU RU RU RU RU RU 2
2B  High ×  RU RU RU RU RU RU DW RU 2
2C  High × RU RU RU RU RU RU MP MP 2
3   ×  DW 3
4   × MP MP 4
[1]: Output flag to LCD screen, printer.
[2]: Output flag to host computer.
: • When analysis results of LD and UD are normal.
• In the case of DW, when RDW-SD could be analyzed.
• In the case of MP, when RBC histogram has a single peak.
High: Frequencies of LD and UD are higher than the range.
×: • In the case of DW, when RDW-SD could not be analyzed.
• In the case of MP, when RBC histogram has 2 or more peaks.
: Any of “ ,” “×,” and “High” is applicable.
Revised January 2017

Sysmex XP-300 14-41


Technical Information

1) 1A Histogram with high frequency for LD


RBC, HCT, MCV, MCH, MCHC, PLT, and particle distribution width data parameters are
flagged with RL. MCV and RDW-SD exceed the upper Patient Mark Limits, and MCHC falls
below the lower Patient Mark Limits.

• RBC Histogram Error - RL (1A)

RBC
RBC RL 3.57 [×106/µL]
HGB 11.5 [g/dL]
HCT RL 41.8 [%]
MCV RL +117.1 [fL]
MCH RL 32.2 [pg]
100 200 250 [fL]
MCHC RL -27.5 [g/dL]
RDW-SD RL +91.7 [fL]
PLT RL 185 [×103/µL]

2) 1B High frequency for LD with 20% particle distribution width error


RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RL. Of the particle
distribution width data, RDW-CV is flagged with RL and its data are output. RDW-SD
parameter is flagged with DW and its data are not output.

3) 1C High LD with 2 or more peaks


RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RL. RDW-CV is
flagged with MP and its data are output, while RDW-SD is flagged with MP but its data are not
output.

4) 2A Frequency high for UD


RBC, HCT, MCV, MCH, MCHC, PLT, and particle distribution width data parameters are
flagged with RU. In this instance, flags to indicate that their data are out of Patient Mark Limits
are added to MCV, MCHC, and RDW-SD.

• RBC Histogram Error - RU (2A)

RBC RBC RU 3.57 [×106/µL]


HGB 11.5 [g/dL]
HCT RU 41.8 [%]
MCV RU +117.1 [fL]
MCH RU 32.2 [pg]
100 200 250 [fL]
MCHC RU -27.5 [g/dL]
RDW-SD RU +91.7 [fL]
Revised January 2017

PLT RU 185 [×103/µL]

14-42 Sysmex XP-300


Technical Information

5) 2B High UD with 20%-frequency distribution width error


RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged. Out of the particle
distribution width data, RDW-CV is flagged with RU and its data are output.
RDW-SD is flagged with DW and its data are not output. In this instance, MCV and MCHC are
out of Patient Mark Limits.

• RBC Histogram Error - RU, DW (2B)

RBC
RBC RU 3.57 [×106/µL]
HGB 11.5 [g/dL]
HCT RU 52.9 [%]
MCV RU +148.2 [fL]
100 200 250 [fL] MCH RU 32.2 [pg]
MCHC RU -21.7 [g/dL]
RDW-SD DW ---.- [fL]
PLT RU 185 [×103/µL]

6) 2C High UD with 2 or more peaks


RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RU. As to particle
distribution width data, RDW-CV is flagged with MP and its data are output, while RDW-SD is
also flagged with MP but its data are not output.

7) 3 20%-frequency particle distribution width error


RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As to the particle
distribution width data, RDW-CV data are output without flagging, while RDW-SD data are
flagged with DW and their data are not output.

8) 4 2 or more peaks
RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As to the particle
distribution width data, RDW-CV data are output with MP flag. RDW-SD is flagged with MP
and its data are not output. In this instance, RDW-CV is out of Patient Mark Limits.

• RBC Histogram Error - MP (4)

RBC
RBC 4.80 [×106/µL]
HGB 14.2 [g/dL]
HCT 41.5 [%]
MCV 86.5 [fL]
MCH 29.6 [pg]
100 200 250 [fL]
MCHC -34.2 [g/dL]
Revised January 2017

RDW-CV MP +33.3 [fL]


PLT 216 [×103/µL]

Sysmex XP-300 14-43


Technical Information

4. Platelet Histogram Error Flag

When the platelet histogram is not normal, a histogram error flag is added to the corresponding
parameter of the analysis value. Those histogram error flags - used with the particle distribution
analysis unit mounted, are listed in the order of higher priority.
When 2 or more flags are applicable to a parameter, the highest priority flag is used.

PL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is the
effect of noise and etc.

PU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable cause is the
effect of platelet agglutination, noise interference, and etc.

MP: 2 or more peaks in histogram

DW: Particle distribution width error for 20% frequency with the peak taken as 100%. When the
20% frequency does not cross the histogram 2 times, this flag is attached.

• Matching of 8 kinds of platelet histogram error flags

Platelet Histogram Error Flag Output


[1] [2]
Case
LD UD DW MP PLT PDW MPV P-LCR PCT HOST
No.
1A High   PL PL PL PL PL 1
1B High ×  PL DW PL PL PL 1
1C High × PL MP PL PL PL 1
2A  High   PU PU PU PU PU 2
2B  High ×  PU DW PU PU PU 2
2C  High × PU MP PU PU PU 2
3   ×  DW DW DW DW 3
4   × MP MP MP MP 4
[1]: Output flag to LCD screen, printer.
[2]: Output flag to host computer.
: • When analysis results of LD and UD are normal.
• In the case of DW, when PDW could be analyzed.
• In the case of MP, when PLT histogram has a single peak.
High: Frequencies of LD and UD are higher than the range.
×: • In the case of DW, when PDW could not be analyzed.
• In the case of MP, when PLT histogram has 2 or more peaks.
: Any of “ ,” “×,” and “High” is applicable.
Revised January 2017

14-44 Sysmex XP-300


Technical Information

1) 1A High frequency for LD


PLT, PDW, MPV, and P-LCR parameters are flagged with PL.

• Platelet Histogram Error - PL (1A)

PLT
PLT PL 211 [×103/µL]
PDW PL 12.5 [fL]
MPV PL 9.3 [fL]
P-LCR PL -22.6 [%]

10 20 30 [fL]

2) 1B High LD with 20%-frequency distribution width error


PLT parameter is flagged with PL. Particle distribution width (PDW) is flagged with DW and its
data are not output.
MPV and P-LCR are flagged with PL and their data are not output.

3) 1C High LD with 2 or more peaks


PLT parameter is flagged with PL. Particle distribution width (PDW) is flagged with MP and its
data are not output.
MPV and P-LCR are flagged with PL and their data are not output.

4) 2A High UD
PLT, PDW, MPV, and P-LCR parameters are flagged with PU.

5) 2B High UD with 20%-frequency particle distribution width error


PLT parameter is flagged with PU. Particle distribution width (PDW) is flagged with DW and
its data are not output.
MPV and P-LCR are flagged with PU and their data are not output.

• Platelet Histogram Error - PU (2B)

PLT
PLT PU 171 [×103/µL]
PDW DW ---.- [fL]
MPV PU ---.- [fL]
P-LCR PU ---.- [%]

10 20 30 [fL]
Revised January 2017

Sysmex XP-300 14-45


Technical Information

6) 2C High UD with 2 or more peaks


PLT parameter is flagged with PU. Particle distribution width (PDW) is flagged with MP and its
data are not output.
MPV and P-LCR are flagged with PU and their data are not output.

7) 3 20%-frequency particle distribution width error


PLT is not flagged. PDW, MPV, and P-LCR are flagged with DW and their data are not output.

• Platelet Histogram Error - DW (3)

PLT
PLT 91 [×103/µL]
PDW DW ---.- [fL]
MPV DW ---.- [fL]
P-LCR DW ---.- [%]

10 20 30 [fL]

8) 4 2 or more peaks
PLT is not flagged. Other parameters are flagged with MP and their data are not output.

• Platelet Histogram Error - MP (4)

PLT
PLT 155 [×103/µL]
PDW MP ---.- [fL]
MPV MP ---.- [fL]
P-LCR MP ---.- [%]

10 20 30 [fL]

Revised January 2017

14-46 Sysmex XP-300


Technical Information

Electric system

The microprocessor in the main unit controls the hydraulic system’s solenoid valves and master
valves, thus regulating the flow of samples, reagents, and waste in the hydraulic system.
Electric signals received from various transducers go through the analogue circuit for electrical
waveform-processing, and to the microcomputer. The microcomputer converts the analogue signals
into digital signals for the calculation.

The WBC, RBC, and PLT cell signals are sent to the respective waveform-processing circuits in the
analogue circuit, where the noise in signals is eliminated to acquire the required cell signals only. The
microcomputer converts the A/D-converted cell signals into particle distribution data, and outputs
them to the printer or to the host computer.

To calculate HGB, absorbance of only the diluent (background) is deducted from samples’
absorbance. The beam that has passed through the fluid is detected by the photo diode. And the
signals is photoelectrically converted, A/D converted, and then sent to the HGB counting circuit for
the calculation of the absorbance.
Revised January 2017

Sysmex XP-300 14-47


Technical Information

14.7 Warranty
All Sysmex instruments are warranted against defective material or
workmanship for a period of 1 year, commencing on the installation
date at the customer's premises.
This warranty does not cover any defect, malfunction or damage due
to:
 Accident, neglect or wilful mistreatment of the product;
 Failure to use, operate, service or maintain the product in
accordance with the applicable Sysmex Instructions for Use;
 Failure to use the appropriate reagents and consumables
specified for the product.

Revised January 2017

14-48 Sysmex XP-300


Revised January 2017

Daily Year: Month:

Sysmex XP-300
Day
Maintenance item 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean TD chambers and
14.8 Appendix

hydraulic system (Shutdown)


Check trap chamber level and
discard
Signature
XP-300 maintenance checklist

Weekly As-needed maintenance


Month Month/Day & Month/Day & Month/Day & Month/Day & Month/Day & Month/Day &
Maintenance item
Maintenance item
Signature Signature Signature Signature Signature Signature
Clean SRV tray Perform Auto Rinse
Signature Clean rinse cup
Dispose of waste fluid
Every month
Clean aperture of TD chamber
Month Month/Day & Month/Day & Month/Day & Month/Day & Calibrate LCD
 Maintenance checklist

Maintenance item
Signature Signature Signature Signature
Adjust pressure and vacuum
Clean TD
 Reagent replenishing record

Clean waste chamber Replace supplies


Signature Month/Day & Month/Day & Month/Day & Month/Day &
Maintenance item
Signature Signature Signature Signature
Every 3 months
Replace Fuse
Maintenance item Month/Day & Signature Month/Day & Signature Replace internal
Clean SRV printer paper

14-49
Technical Information
14-50
CELLPACK
Lot ID Month/Day Expiration date Signature Lot ID Month/Day Expiration date Signature
Technical Information

Reagent replenishing record

STROMATOLYSER-WH
Lot ID Month/Day Expiration date Signature Lot ID Month/Day Expiration date Signature

Sysmex XP-300
Revised January 2017
Technical Information

14.9 GNU GENERAL PUBLIC LICENSE


Software used with this product
A portion of the software used with this product is subject to the GNU General Public License.
Person wishing to obtain the source code or detailed information concerning the software used with this product
that is subject to the GNU General Public License should contact your local Sysmex representative.
For the software used with this product that is not subject to the GNU General Public License, the source code
may not be obtained, reverse engineered, decompiled, or disassembled.

GNU GENERAL PUBLIC LICENSE


Version 2, June 1991
Copyright (C) 1989, 1991 Free Software Foundation, Inc.
59 Temple Place, Suite 330, Boston, MA 02111-1307 USA
Everyone is permitted to copy and distribute verbatim copies of this license document, but changing it is
not allowed.
Preamble

The licenses for most software are designed to take away your freedom to share and change it. By
contrast, the GNU General Public License is intended to guarantee your freedom to share and change
free software--to make sure the software is free for all its users. This General Public License applies to
most of the Free Software Foundation's software and to any other program whose authors commit to
using it. (Some other Free Software Foundation software is covered by the GNU Library General
Public License instead.) You can apply it to your programs, too.
When we speak of free software, we are referring to freedom, not price. Our General Public Licenses
are designed to make sure that you have the freedom to distribute copies of free software (and charge for
this service if you wish), that you receive source code or can get it if you want it, that you can change
the software or use pieces of it in new free programs; and that you know you can do these things.
To protect your rights, we need to make restrictions that forbid anyone to deny you these rights or to
ask you to surrender the rights.
These restrictions translate to certain responsibilities for you if you distribute copies of the software, or
if you modify it.
For example, if you distribute copies of such a program, whether gratis or for a fee, you must give the
recipients all the rights that you have. You must make sure that they, too, receive or can get the source
code. And you must show them these terms so they know their rights.
We protect your rights with two steps: (1) copyright the software, and (2) offer you this license which
gives you legal permission to copy, distribute and/or modify the software.
Also, for each author's protection and ours, we want to make certain that everyone understands that
there is no warranty for this free software. If the software is modified by someone else and passed on,
we want its recipients to know that what they have is not the original, so that any problems introduced
by others will not reflect on the original authors' reputations.
Finally, any free program is threatened constantly by software patents. We wish to avoid the danger
that redistributors of a free program will individually obtain patent licenses, in effect making the
program proprietary. To prevent this, we have made it clear that any patent must be licensed for
everyone's free use or not licensed at all.
The precise terms and conditions for copying, distribution and modification follow.
Revised January 2017

Sysmex XP-300 14-51


Technical Information

GNU GENERAL PUBLIC LICENSE


TERMS AND CONDITIONS FOR COPYING, DISTRIBUTION AND MODIFICATION

0. This License applies to any program or other work which contains a notice placed by the copyright
holder saying it may be distributed under the terms of this General Public License. The "Program",
below, refers to any such program or work, and a "work based on the Program" means either the
Program or any derivative work under copyright law: that is to say, a work containing the Program or
a portion of it, either verbatim or with modifications and/or translated into another language.
(Hereinafter, translation is included without limitation in the term "modification".) Each licensee is
addressed as "you".
Activities other than copying, distribution and modification are not covered by this License; they are
outside its scope. The act of running the Program is not restricted, and the output from the Program is
covered only if its contents constitute a work based on the Program (independent of having been made
by running the Program).
Whether that is true depends on what the Program does.
1. You may copy and distribute verbatim copies of the Program's source code as you receive it, in any
medium, provided that you conspicuously and appropriately publish on each copy an appropriate
copyright notice and disclaimer of warranty; keep intact all the notices that refer to this License and
to the absence of any warranty; and give any other recipients of the Program a copy of this License
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You may charge a fee for the physical act of transferring a copy, and you may at your option offer
warranty protection in exchange for a fee.
2. You may modify your copy or copies of the Program or any portion of it, thus forming a work based
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above, provided that you also meet all of these conditions:
a) You must cause the modified files to carry prominent notices stating that you changed the files
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b) You must cause any work that you distribute or publish, that in whole or in part contains or is
derived from the Program or any part thereof, to be licensed as a whole at no charge to all third
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c) If the modified program normally reads commands interactively when run, you must cause it,
when started running for such interactive use in the most ordinary way, to print or display an
announcement including an appropriate copyright notice and a notice that there is no warranty
(or else, saying that you provide a warranty) and that users may redistribute the program under
these conditions, and telling the user how to view a copy of this License. (Exception: if the
Program itself is interactive but does not normally print such an announcement, your work
based on the Program is not required to print an announcement.)
These requirements apply to the modified work as a whole. If identifiable sections of that work are not
derived from the Program, and can be reasonably considered independent and separate works in
themselves, then this License, and its terms, do not apply to those sections when you distribute them as
separate works. But when you distribute the same sections as part of a whole which is a work based on
the Program, the distribution of the whole must be on the terms of this License, whose permissions for
other licensees extend to the entire whole, and thus to each and every part regardless of who wrote it.
Thus, it is not the intent of this section to claim rights or contest your rights to work written entirely by
you; rather, the intent is to exercise the right to control the distribution of derivative or collective works
based on the Program.
In addition, mere aggregation of another work not based on the Program with the Program (or with a
work based on the Program) on a volume of a storage or distribution medium does not bring the other
work under the scope of this License.
Revised January 2017

14-52 Sysmex XP-300


Technical Information

3. You may copy and distribute the Program (or a work based on it, under Section 2) in object code or
executable form under the terms of Sections 1 and 2 above provided that you also do one of the
following:
a) Accompany it with the complete corresponding machine-readable source code, which must be
distributed under the terms of Sections 1 and 2 above on a medium customarily used for
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b) Accompany it with a written offer, valid for at least three years, to give any third party, for a
charge no more than your cost of physically performing source distribution, a complete
machine-readable copy of the corresponding source code, to be distributed under the terms of
Sections 1 and 2 above on a medium customarily used for software interchange; or,
c) Accompany it with the information you received as to the offer to distribute corresponding
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received the program in object code or executable form with such an offer, in accord with
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If distribution of executable or object code is made by offering access to copy from a designated place,
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4. You may not copy, modify, sublicense, or distribute the Program except as expressly provided under
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and will automatically terminate your rights under this License.
However, parties who have received copies, or rights, from you under this License will not have their
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5. You are not required to accept this License, since you have not signed it. However, nothing else
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6. Each time you redistribute the Program (or any work based on the Program), the recipient
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7. If, as a consequence of a court judgment or allegation of patent infringement or for any other reason
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could satisfy both it and this License would be to refrain entirely from distribution of the Program.
If any portion of this section is held invalid or unenforceable under any particular circumstance, the
balance of the section is intended to apply and the section as a whole is intended to apply in other
circumstances.
Revised January 2017

Sysmex XP-300 14-53


Technical Information

It is not the purpose of this section to induce you to infringe any patents or other property right claims or
to contest validity of any such claims; this section has the sole purpose of protecting the integrity of the
free software distribution system, which is implemented by public license practices. Many people have
made generous contributions to the wide range of software distributed through that system in reliance
on consistent application of that system; it is up to the author/donor to decide if he or she is willing to
distribute software through any other system and a licensee cannot impose that choice.
This section is intended to make thoroughly clear what is believed to be a consequence of the rest of this
License.
8. If the distribution and/or use of the Program is restricted in certain countries either by patents or by
copyrighted interfaces, the original copyright holder who places the Program under this License may
add an explicit geographical distribution limitation excluding those countries, so that distribution is
permitted only in or among countries not thus excluded. In such case, this License incorporates the
limitation as if written in the body of this License.
9. The Free Software Foundation may publish revised and/or new versions of the General Public
License from time to time. Such new versions will be similar in spirit to the present version, but may
differ in detail to address new problems or concerns.
Each version is given a distinguishing version number. If the Program specifies a version number of
this License which applies to it and "any later version", you have the option of following the terms and
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the Program does not specify a version number of this License, you may choose any version ever
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10. If you wish to incorporate parts of the Program into other free programs whose distribution
conditions are different, write to the author to ask for permission. For software which is copyrighted
by the Free Software Foundation, write to the Free Software Foundation; we sometimes make
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derivatives of our free software and of promoting the sharing and reuse of software generally.

NO WARRANTY

11. BECAUSE THE PROGRAM IS LICENSED FREE OF CHARGE, THERE IS NO WARRANTY


FOR THE PROGRAM, TO THE EXTENT PERMITTED BY APPLICABLE LAW. EXCEPT
WHENOTHERWISE STATED IN WRITING THE COPYRIGHT HOLDERS AND/OR OTHER
PARTIES PROVIDE THE PROGRAM "AS IS" WITHOUT WARRANTY OF ANY KIND,
EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THE PROGRAM IS
WITH YOU. SHOULD THE PROGRAM PROVE DEFECTIVE, YOU ASSUME THE COST OF
ALL NECESSARY SERVICING, REPAIR OR CORRECTION.
12. IN NO EVENT UNLESS REQUIRED BY APPLICABLE LAW OR AGREED TO IN WRITING
WILL ANY COPYRIGHT HOLDER, OR ANY OTHER PARTY WHO MAY MODIFY AND/OR
REDISTRIBUTE THE PROGRAM AS PERMITTED ABOVE, BE LIABLE TO YOU FOR
DAMAGES, INCLUDING ANY GENERAL, SPECIAL, INCIDENTAL OR CONSEQUENTIAL
DAMAGES ARISING OUT OF THE USE OR INABILITY TO USE THE PROGRAM
(INCLUDING BUT NOT LIMITED TO LOSS OF DATA OR DATA BEING RENDERED
INACCURATE OR LOSSES SUSTAINED BY YOU OR THIRD PARTIES OR A FAILURE OF
THE PROGRAM TO OPERATE WITH ANY OTHER PROGRAMS), EVEN IF SUCH HOLDER
OR OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Revised January 2017

14-54 Sysmex XP-300


Technical Information

END OF TERMS AND CONDITIONS


How to Apply These Terms to Your New Programs
If you develop a new program, and you want it to be of the greatest possible use to the public, the best
way to achieve this is to make it free software which everyone can redistribute and change under these
terms.
To do so, attach the following notices to the program. It is safest to attach them to the start of each
source file to most effectively convey the exclusion of warranty; and each file should have at least the
"copyright" line and a pointer to where the full notice is found.
<one line to give the program's name and a brief idea of what it does.>
Copyright (C) 19yy <name of author>
This program is free software; you can redistribute it and/or modify it under the terms of the GNU
General Public License as published by the Free Software Foundation; either version 2 of the
License, or (at your option) any later version.
This program is distributed in the hope that it will be useful, but WITHOUT ANY WARRANTY;
without even the implied warranty of MERCHANTABILITY or FITNESS FOR A
PARTICULAR PURPOSE. See the GNU General Public License for more details.
You should have received a copy of the GNU General Public License along with this program; if
not, write to the Free Software Foundation, Inc., 59 Temple Place, Suite 330, Boston, MA 02111-
1307 USA
Also add information on how to contact you by electronic and paper mail.
If the program is interactive, make it output a short notice like this when it starts in an interactive mode:
Gnomovision version 69, Copyright (C) 19yy name of author
Gnomovision comes with ABSOLUTELY NO WARRANTY; for details type `show w'.
This is free software, and you are welcome to redistribute it under certain conditions; type `show
c' for details.
The hypothetical commands ‘show w’ and ‘show c’ should show the appropriate parts of the General
Public License. Of course, the commands you use may be called something other than ‘show w’ and
‘show c’; they could even be mouse-clicks or menu items--whatever suits your program.
You should also get your employer (if you work as a programmer) or your school, if any, to sign a
"copyright disclaimer" for the program, if necessary. Here is a sample; alter the names:
Yoyodyne, Inc., hereby disclaims all copyright interest in the program ‘Gnomovision’ (which
makes passes at compilers) written by James Hacker.
<signature of Ty Coon>, 1 April 1989
Ty Coon, President of Vice
This General Public License does not permit incorporating your program into proprietary programs. If
your program is a subroutine library, you may consider it more useful to permit linking proprietary
applications with the library. If this is what you want to do, use the GNU Library General Public
License instead of this License.
Revised January 2017

Sysmex XP-300 14-55


Technical Information

Revised January 2017

14-56 Sysmex XP-300


Index

Index
Numerics C
–0.0333MPa Vacuum Error...................................... 13-7 Calculating the calibration value .............................. 10-9
0.05MPa Pressure Error............................................ 13-7 Calculation of RBC constant .................................. 14-28
Calibrate LCD screen ............................................. 12-23
A Calibration ................................................................ 10-1
Abbreviations ............................................................. 1-4 Calibration flow chart............................................... 10-2
Abbreviations and units used throughout this Carryover .................................................................. 14-5
manual................................................................... 1-4 CBC analysis .......................................................... 14-24
Accuracy: Pre-diluted mode ..................................... 14-4 CELLCLEAN............................................................. 4-3
Accuracy: Whole blood mode .................................. 14-4 CELLPACK................................................................ 4-1
Action message screen ............................................... 6-3 CELLPACK expired............................................... 13-10
Additional special equipment ..................................... 9-2 Check digit.............................................................. 14-17
Adjust pressure and vacuum................................... 12-26 Check instrument status............................................ 12-2
Adjusting pressure to 0.05 MPa ............................. 12-28 Check trap chamber level and discard...................... 12-5
Adjusting the contrast of the LCD screen ................ 5-17 Checking the program version.................................. 12-2
Adjusting vacuum to –0.0333 MPa ........................ 12-29 Checks prior to operation ........................................... 7-3
Alphabetical error message index ............................ 13-4 Clean aperture of TD chamber
Analysis in pre-diluted (PD) mode........................... 7-17 (drain TD chamber)........................................... 12-20
Analysis in whole blood (WB) mode ......................... 7-8 Clean rinse cup ....................................................... 12-17
Analysis modes........................................................... 7-1 Clean SRV .............................................................. 12-11
Analysis of histogram............................................. 14-30 Clean SRV tray......................................................... 12-6
Analysis of RBC/PLT histogram............................ 14-39 Clean TD................................................................... 12-7
Analysis of WBC histogram................................... 14-30 Clean TD chambers and diluted sample lines
Analysis parameters.......................................... 1-5, 14-1 (Shutdown).......................................................... 12-3
Analysis principle ..................................................... 14-2 Clean the SRV ........................................................ 13-17
Analysis range .......................................................... 14-1 Clean Transducer.................................................... 13-17
Analyzing samples.......................................... 7-15, 7-25 Clean Waste Chamber ............................................ 13-17
Aperture Clog (RBC) ............................................. 13-11 Clean waste chamber ................................................ 12-9
Aperture Clog (WBC) ............................................ 13-11 Cleaning and maintenance........................................ 12-1
Appendix ................................................................ 14-49 Composition ............................................................... 9-2
As-needed maintenance............................................ 12-1 Connect CELLPACK ................................................. 5-8
Automatic calibration ............................................... 10-4 Connect STROMATOLYSER-WH ........................... 5-9
Automatic settings of the TARGET value and Connect waste line...................................................... 5-9
LIMIT value........................................................ 9-15 Connecting the bar code reader .............................. 14-12
Automatic stop function ............................................. 6-6 Connection of a host computer, printer and
Avoiding infections .................................................... 2-3 handheld bar code reader .................................... 5-13
Connection of power cable ....................................... 5-14
Connection of reagents and waste bottle .................... 5-7
B Connection procedure............................................. 14-12
Background check ...................................................... 7-6 Consumable list ...................................................... 12-38
Background limits .................................................... 14-1 Consumption of reagent............................................ 14-2
Bar code element dimensions ................................. 14-15 Contact address........................................................... 1-2
Bar code label dimensions...................................... 14-16 Contamination Level ................................................ 14-1
Bar code reader settings.......................................... 14-13 Control material................................................ 9-1, 14-2
Basic instrument settings .......................................... 5-15 Control method selection............................................ 9-7
Basic operation area ................................................... 6-2 Control methods ......................................................... 9-5
Before installation ...................................................... 5-2
Blank Error ............................................................. 13-12
Blood cell discrimination circuit ............................ 14-29
Blood volume aspirated ............................................ 14-2
Revised January 2017

Sysmex XP-300 i
Index

D Examples of printed results on the list


Daily.......................................................................... 12-1 printer (LP)........................................................ 14-11
Data processing area ................................................... 6-2 Executing the stored data processing program ......... 8-11
Data storage .............................................................. 14-2 External output.......................................................... 9-27
Date and time settings............................................... 5-15
Date/Time ................................................................. 11-4 F
DC detection method .............................................. 14-21 File transmission ......................................................... 6-9
Decontamination ......................................................... 2-8 First analysis result screen .......................................... 8-2
Deleting data ............................................................. 9-28 First list screen .......................................................... 8-13
Deleting stored data .................................................. 8-20 Flowchart of analysis procedure ................................. 7-2
Description of the analysis result screens ................... 8-4 Fourth analysis result screen....................................... 8-3
Description of the detail screens ............................... 8-16 Fourth list screen....................................................... 8-14
Description of the reagent replacement history Front interior ............................................................... 3-5
screen................................................................. 12-34 Front view ................................................................... 3-1
Design and function .................................................... 3-1 Functional description............................................. 14-21
Detail screen ............................................................. 8-16
Detection principle.................................................. 14-21
G
Detergent................................................................... 14-1
General...................................................................... 13-3
Dialog screen .............................................................. 6-3
General information ............................................ 2-1, 4-1
Dimensions ............................................................... 14-5
GNU GENERAL PUBLIC LICENSE.................... 14-51
Display and output of analysis results ........................ 8-1
GP Buffer Full......................................................... 13-21
Display column ........................................................... 6-3
GP paper empty....................................................... 13-20
Display items in list screens...................................... 8-15
GP printout error ..................................................... 13-20
Display items in quality control chart screens .......... 9-26
Graphic printer .......................................................... 5-13
Display of analysis results ........................................ 7-27
Display range ............................................................ 14-1
Disposal ...................................................................... 9-4 H
Disposal of waste fluid, waste materials, and the Handheld bar code reader ......................................... 5-13
device .................................................................... 2-6 Handling of reagents ................................................... 2-4
Dispose waste fluid ................................................. 12-19 Hardware specifications.......................................... 14-13
Drain TD chamber .................................................. 12-20 HC ACK Timeout ................................................... 13-20
HC Buffer Full ........................................................ 13-19
HC NAK Retry ....................................................... 13-20
E
HC Off-line ............................................................. 13-20
Editing the sample ID ................................................. 8-9
Heat compensation required ..................................... 14-5
EIGHTCHECK-3WP.................................................. 4-4
HGB Error............................................................... 13-14
Electric system ........................................................ 14-47
Histogram error flags ................................................ 8-21
Electromagnetic compatibility (EMC)........................ 2-2
Host Output............................................................... 11-6
EMC (Electro-magnetic compatibility) .................... 14-5
EMC Conformity Assessment Standards ................. 14-5
Emergency call ......................................................... 6-10 I
Emergency stop procedure.......................................... 6-7 ID Bar code specifications ...................................... 14-15
End of operation (Shutdown).................................... 7-28 Impulse Resistance (Excess voltage) category ......... 14-1
Entering a sample ID ........................................ 7-9, 7-19 Initial operation........................................................... 5-1
Entering from handheld bar code reader Inspection of reagents ................................................. 7-3
.................................... 7-11, 7-13, 7-21, 7-23, 9-13 Installation................................................................... 2-2
Entering from numerical keys dialog Instrument setup........................................................ 11-1
.................................... 7-10, 7-12, 7-20, 7-22, 9-10 Intended purpose......................................................... 9-1
Entering target values ............................................... 10-6 Intended use ................................................................ 1-3
Error massage index by function .............................. 13-5 Internal printer paper (Printing Paper No. 3) .............. 7-3
Error messages .......................................................... 13-3 Introduction................................................................. 1-1
Error messages, possible causes and actions to Introduction (Initial Operation)................................... 5-1
revolve the error .................................................. 13-7 Introduction (Instrument Setup)................................ 11-1
Error report ................................................................. 6-8 Introduction (Sample Analysis) .................................. 7-1
Revised January 2017

Establishing reference values.................................... 10-3 IP Cover Open......................................................... 13-18


Every 3 months (or every 4,500 samples) ................ 12-1 Irregularity and roughness of printing .................... 14-16
Every month (or every 1,500 samples) ..................... 12-1
Examples of printed results on the graphic
printer (GP) ....................................................... 14-10

ii Sysmex XP-300
Index

L PLT Noise Error ..................................................... 13-13


LAN Buffer Full ..................................................... 13-19 PLT Smp’g Error .................................................... 13-13
LAN no Response................................................... 13-19 Pneumatic unit stop function ...................................... 6-6
Latest sample (analysis result screen) ........................ 8-1 Possible sample interferences................................... 14-7
Left side interior ......................................................... 3-6 Possible settings........................................................ 11-3
Left side panel ............................................................ 3-3 Power cable................................................................. 7-3
Levey-Jennings (L-J) control ..................................... 9-5 Power consumption .................................................. 14-5
Linearity: Whole blood mode................................... 14-5 Power supply ............................................................ 14-5
List of consumables ................................................ 12-38 Precision (repeatability): Pre-diluted mode.............. 14-4
List of provided parts for XP-300 .............................. 5-2 Precision (repeatability): Whole blood mode........... 14-3
L-J control ................................................................ 9-21 Preparation of installation location............................. 5-4
Location of control knobs....................................... 12-27 Prepare internal printer paper
(Printing Paper No. 3) ......................................... 5-11
Prepare reagent ........................................................... 5-7
M
Pressure/Vac Error.................................................... 13-8
Main screen/Menu screen........................................... 6-1
Print and output of analysis results........................... 7-27
Maintenance ............................................................... 2-5
Print Buffer Full...................................................... 13-18
Maintenance report ..................................................... 6-8
Print error log.......................................................... 13-22
Maintenance schedule .............................................. 12-1
Print formats ............................................................. 14-9
Manual calibration.................................................... 10-9
Print settings ........................................................... 11-11
Manual discrimination................................................ 8-6
Printer ....................................................................... 11-7
Manual procedures ..................................................... 9-3
Printing calibration history ..................................... 10-12
Manual stop function .................................................. 6-6
Printing control chart ................................................ 9-27
Manual transmission (File transmission).................... 6-9
Procedure .................................................................... 9-3
Measuring unit hydraulic system block diagram.... 14-23
Product ID................................................................. 11-6
Menu tree.................................................................... 6-5
Product name .............................................................. 9-1
Methodology............................................................... 9-3
Protection type.......................................................... 14-5
PS (Print screen) ......................................................... 6-9
N
Network .................................................................... 11-8
Q
No Printer Paper ..................................................... 13-18
QC Data Error......................................................... 13-15
Noise level ................................................................ 14-5
QC Error ................................................................. 13-16
Non-cyanide hemoglobin analysis method ............ 14-22
QC(L-J) Error ......................................................... 13-16
Numerical keys dialog ................................................ 6-4
QC(X-bar) Error ..................................................... 13-16
Quality control............................... 7-6, 9-1, 11-6, 14-2
O Quality control chart screen............................ 9-24, 9-25
Online QC................................................................... 6-8 Quality control process flow....................................... 9-6
Operating Environment ............................................ 14-1
Operation .................................................................... 6-1
R
Operator ID..................................................... 7-12, 7-22
RAM Error.............................................................. 13-15
Operators .................................................................. 2-13
Rated input/output condition .................................... 14-6
Ordering of supplies and replacement parts ............... 1-2
RBC Analysis Err ................................................... 13-14
Output of analysis result (latest sample) .................. 8-10
RBC discriminator.................................................. 14-29
Output of stored data ................................................ 8-19
RBC Histogram ...................................................... 14-39
Output on internal printer (IP) .................................. 14-9
RBC Histogram Error Flag..................................... 14-41
RBC Noise Error .................................................... 13-13
P RBC Smp’g Error ................................................... 13-13
Password setting ....................................................... 11-9 RBC/PLT analysis flow.......................................... 14-26
Password setting procedure ...................................... 11-9 Reagent ..................................................................... 14-1
Patient Limits............................................................ 11-5 Reagent replacement history screen ....................... 12-34
PCS (Print Contrast Signal) value .......................... 14-16 Reagent replacement log ........................................ 12-33
Perform Auto Rinse ................................................ 12-15 Reagent replenishing record ................................... 14-50
Performing a quality control..................................... 9-16
Revised January 2017

Reagent specifications ................................................ 4-6


Performing analysis .................................................. 10-7 Reagents...................................................................... 4-1
Peripheral devices (optional) .................................... 5-13 Reagents list............................................................ 12-38
Platelet Histogram Error Flag................................. 14-44 Rear side ..................................................................... 3-4
PLT discriminator................................................... 14-29 References .................................................................. 9-4
PLT Histogram ....................................................... 14-40

Sysmex XP-300 iii


Index

Registering the operator ID............................. 7-12, 7-22 Switching ON.............................................................. 7-5


Removal of packing tape ............................................ 5-5 Symbologies used ................................................... 14-15
Replace CELLPACK ................................................ 13-9 Symbols used in this manual....................................... 1-3
Replace internal printer paper Symbols used on the labels ......................................... 4-5
(Printing Paper No. 3) ....................................... 12-36 System....................................................................... 11-3
Replace reagent....................................................... 12-30 System area ................................................................. 6-1
Replace STROMATOLYSER .................................. 13-9 System limits............................................................. 14-7
Replace system fuses .............................................. 12-35 System of units........................................................ 14-19
Required sample volume .......................................... 14-2
Reset SRV cycle counter ........................................ 12-25 T
Right view................................................................... 3-2 Technical information............................................... 14-1
Rinse MC error ....................................................... 13-11 Third analysis result screen......................................... 8-3
Rinse motor error .................................................... 13-11 Third list screen......................................................... 8-14
ROM Error .............................................................. 13-15 Throughput................................................................ 14-2
Room Temp(H)....................................................... 13-12 Timer functions........................................................... 6-7
Room Temp(L) ....................................................... 13-12 Traceability of control materials................................. 9-4
Trademarks ................................................................. 1-4
S Training courses.......................................................... 1-2
S.LYSER expired.................................................... 13-10 Troubleshooting ........................................................ 13-1
Safety ........................................................................ 14-5
Safety information ...................................................... 2-1 U
Sample analysis........................................................... 7-1 Unit ............................................................................. 1-5
Sample preparation ........................................... 7-8, 7-17 Updating calibration values .......................... 10-8, 10-10
Samples used for calibration..................................... 10-3 Usage location........................................................... 14-1
Screen display ............................................................. 6-1
Screen saving method (Print screen) .......................... 6-9
Searching stored data ................................................ 8-17 W
Second analysis result screen...................................... 8-2 Warning and precautions ............................................ 9-2
Second list screen...................................................... 8-13 Warning labels on the instrument ............................... 2-9
Selecting automatic calibration mode and Warranty ................................................................. 14-48
parameters ........................................................... 10-4 Waste disposal ............................................................ 2-7
Selecting the operator ID ................................ 7-14, 7-24 Waste not drained ..................................................... 13-8
Selections .................................................................... 6-3 WBC Analysis Err .................................................. 13-14
Self-check ................................................................... 7-5 WBC discriminator ................................................. 14-29
Service and maintenance ............................................ 1-2 WBC Histogram...................................................... 14-30
Setting the analysis mode ................................. 7-9, 7-19 WBC Histogram Error Flag .................................... 14-32
Settings Error .......................................................... 13-15 WBC Noise Error.................................................... 13-13
Settings for control blood information (QC files) ...... 9-9 WBC research parameters....................................... 14-31
Shutdown .................................................................. 12-3 WBC Smp’g Error .................................................. 13-13
Signal tones................................................................. 6-6 WBC/HGB analysis flow........................................ 14-24
SNCS Comm. Error ................................................ 13-21 Weekly ...................................................................... 12-1
SNCS Connection Error.......................................... 13-21 Weight....................................................................... 14-5
SNCS functions........................................................... 6-7 When you suspect an error........................................ 13-2
SNCS service contract ................................................ 6-8
SNCS Setting Error................................................. 13-21 X
SNCS Status Error .................................................. 13-21 X control ........................................................... 9-5, 9-17
Software .................................................................. 14-51 XP-300 maintenance checklist................................ 14-49
Software specifications ........................................... 14-14
Specifications............................................................ 14-1
Specimen requirements............................................... 7-7
Starting up quality control chart screen .................... 9-24
Storage (transportation) condition ............................ 14-1
Storage and shelf life after first opening..................... 9-2
Revised January 2017

Stored data ................................................................ 8-11


Stored data screen ..................................................... 8-12
Stored Error............................................................. 13-15
STROMATOLYSER-WH.......................................... 4-2
Surface reflection .................................................... 14-16

iv Sysmex XP-300

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