Edition: 16

Chapter 1 Specifications
1.1 Name ......................................................................................................................................... 1
1.1.1 Generic name................................................................................................................... 1
1.1.2 Brand name...................................................................................................................... 1
1.1.3 Model ............................................................................................................................... 1
1.2 Terminology ............................................................................................................................... 2
1.3 Components and system expandability ..................................................................................... 3
1.3.1 Models.............................................................................................................................. 3
1.3.2 Reagents.......................................................................................................................... 4
1.3.3 Control blood, calibrator, and linearity check reagent ...................................................... 4
1.3.4 Interfaces with other devices............................................................................................ 5
1.3.5 Pneumatic unit ................................................................................................................. 5
1.3.6 System expandability (peripheral devices)....................................................................... 5
1.3.7 System expandability (software) ...................................................................................... 5
1.4 Performance .............................................................................................................................. 6
1.4.1 Intended use .................................................................................................................... 6
1.4.1.1 Intended use........................................................................................................... 6
1.4.2 Analysis principles............................................................................................................ 6
1.4.2.1 Blood quantification method ................................................................................... 6
1.4.2.2 WBC analysis ......................................................................................................... 6
1.4.2.3 DIFF analysis.......................................................................................................... 6
1.4.2.4 RET / PLT-O analysis............................................................................................. 6
1.4.2.5 RBC / PLT-I analysis .............................................................................................. 6
1.4.2.6 HGB analysis.......................................................................................................... 6
1.4.3 Analysis parameters and displayed items ........................................................................ 7
1.4.3.1 Analysis mode ........................................................................................................ 7
1.4.3.2 Analysis discrete mode and analysis channel ........................................................ 8
1.4.3.3 Analysis parameters and display items .................................................................. 8
1.4.3.4 Size of RBC aperture/nozzle and FCM flow cell/nozzle ........................................ 8
1.4.4 Analysis ranges and display ranges................................................................................. 9
1.4.5 Reproducibility.................................................................................................................. 9
1.4.6 Accuracy .......................................................................................................................... 9
1.4.6.1 Blood cell count parameters ................................................................................... 9
1.4.6.2 Hemoglobin (HGB) ................................................................................................. 9
1.4.6.3 Hemacrit (HCT) ...................................................................................................... 9
1.4.6.4 Differential blood count parameters...................................................................... 10
1.4.6.5 Reticulocyte parameters (RET#, RET%, LFR, MFR, HFR, IRF, RET-He) ........... 10
1.4.7 Linearity.......................................................................................................................... 10
1.4.8 Carryover ....................................................................................................................... 10
1.4.9 Stability........................................................................................................................... 10
1.4.9.1 Temperature stability ............................................................................................ 10
1.4.9.2 Temporal stability (changes during day)............................................................... 10
1.4.9.3 Temporal stability (daily changes) ........................................................................ 11
1.4.9.4 Voltage stability (voltage changes)....................................................................... 11
1.4.9.5 Temperature cycle testing .................................................................................... 11
1.4.9.6 Temporal stability (temporal stability of blood sample after collection) ................ 11
1.4.10 Sample throughput ......................................................................................................... 11
1.4.11 Reagent volumes ........................................................................................................... 12
1.5 Traceability............................................................................................................................... 12
1.6 Noise........................................................................................................................................ 12
1.7 Exterior view, dimensions, and weight..................................................................................... 12
1.8 Usage conditions ..................................................................................................................... 12
1.8.1 Environment ................................................................................................................... 12
1.8.2 Power supply.................................................................................................................. 12
1.8.3 Laser class ..................................................................................................................... 13
1.8.4 Protection type ............................................................................................................... 13

XN-L S/M November 2016

 Edition: 16

1.8.5 Usable reagents ............................................................................................................. 13

1.8.6 Calorific value................................................................................................................. 13
1.9 Operation and usage methods................................................................................................. 13
1.9.1 Test container ................................................................................................................ 13
1.9.1.1 Regular sample tubes........................................................................................... 13
1.9.1.2 Micro tubes ........................................................................................................... 13
1.9.1.3 Raised Bottom Tube (RBT) .................................................................................. 13
1.9.2 Types of analysis ........................................................................................................... 14
1.9.2.1 Manual analysis.................................................................................................... 14
1.9.2.2 Sampler analysis .................................................................................................. 14
1.9.3 Maintenance sequence .................................................................................................. 14
1.10 Reliability.................................................................................................................................. 15
1.10.1 Expected Design life ...................................................................................................... 15
1.11 Maintainability (serviceability) .................................................................................................. 15
1.11.1 Parts replaced regularly and regular maintenance......................................................... 15
1.12 Storage and transportation conditions ..................................................................................... 15
1.12.1 Storage conditions ......................................................................................................... 15

XN-L S/M November 2016

Chapter 1 Specifications

1.1 Name

1.1.1 Generic name

Blood cell counter

1.1.2 Brand name

Automated Hematology Analyzer XN-L series

1.1.3 Model

Tender model
Regular model
Model for bid market
Sampler analysis type
Samples are placed in the sampler adapter XN-550 XN-530
and analyzed automatically
Closed analysis type
A single sample is placed and automatically XN-450 XN-430
analyzed
Open analysis type
A single sample is placed and analyzed XN-350 XN-330
manually

XN-L S/M 1-1 November 2016

1.2 Terminology
IPU: Computer for device control and data management. Incorporated in the
analyzer unit in the XN-L series.

SNCS: Sysmex Network Communication Systems

Body fluid: General celomic fluid in laboratory testing. Body fluid includes cerebrospinal
fluid, serous fluid (peritoneal and pleural), synovial fluid, and peritoneal dialysis
fluid.

Total nuclear cell count: Count of nuclear cells in body fluid sample. In addition to white blood cells,
body fluid contains a variety of other nuclear cells including mesothelial cells,
plasma cells, histiocytes, and tumor cells.

Whole blood mode: Used for analysis of whole blood

Low WBC mode: Used for analysis of low WBC using whole blood.

Dilution mode: Used for analysis of a minute amount of blood collected from the earlobe or
fingertip.

Body fluid mode: Used for analysis of body fluid (cerebrospinal fluid, serous fluid (peritoneal and
pleural), synovial fluid, and peritoneal dialysis fluid)

Micro analysis: A type of manual anavlysis whereby analysis is performed without a cap on the
sample tube to reduce dead volume. The conditions for micro analysis are as
follows:
• [Cap Open] is set to ON in the Manual Analysis screen
• Analysis is performed in [Dilution] mode
• A micro collection tube is used

Body fluid analysis: A type of manual analysis used to analyze body fluid.

RBT analysis: A type of manual analysis that uses a raised bottom tube (RBT) to reduce
dead volume.

XN-L S/M 1-2 November 2016

1.3 Components and system expandability

1.3.1 Models
Three hardware model types are available: XN-550 / XN-530 (sampler analysis type), XN-450 / XN-430
(closed analysis type), and XN-350 / XN-330 (open analysis type). These models are also divided into
regular models (XN-550, 450, 350) and tender models (XN-530, 430, 330).
On the XN-550, 450, and 350 models, the parameters RET, body fluid, and low WBC, and an increased
number of samples processed per hour, are available as options by means of a software license. The
number of samples processed per hour is about 70.
On the XN-530, 430, and 330 tender types, functions such as the number of storable samples, patient
registration, and analysis registration are limited.

Model list

XN-550/XN-530 XN-450/XN-430 XN-350/XN-330

Sampler analysis type Closed analysis type Open analysis type

Analysis CBC+DIFF ✓ ✓ ✓
channel RET Option Option Option
Analysis Whole blood ✓ ✓ ✓
mode Dilution ✓ ✓ ✓
Low WBC Option Option Option
Body fluid Option Option Option
Infection / anemia
management Option Option Option
flagging
Sampler Sampler (10 samples x2) -
Touch panel monitor External Incorporated Incorporated
Closed / open
Supported sample tubes (When manual analysis is Closed / open Open
performed)
Aspiration volume Approx. 25 µL
Number of samples
Approx. 60 samples (approx. 70 samples available as an option)
processed per hour

✓:Equipped, -: Not equipped; options are available based on a software license key.

Specification comparison table

Regular models Tender models

XN-550/450/350 XN-530/430/330
Stored samples Maximum
100,000 10,000
number storable
Patient registration Maximum
10,000 5,000
registration number
Analysis registration Maximum
2,000 1,000
registration number
Maximum number of QC files 99 20
Maximum number of QC plots 300 300
Logs Maximum number storable 5,000 500

XN-L S/M 1-3 November 2016

1.3.2 Reagents
Reagents are shown below. As a basic rule, reagents are the same as in the XN series. However,
considering that the number of samples processed per day will be less than the XN series, lower volume
packages will be developed for Lysercell WDF and Fluorocell WDF. Usage temperature is 15 to 35°C, the
same as the instrument.

Reagents

Japan Other countries/regions

Volume Package Volume Package
20L x1 Bag-in-box 20L x1 Bag-in-box
CELLPACK DCL
10L x1 Bag-in-box 10L x1 Bag-in-box
Diluent
1.5L x2 Carton - -
CELLPACK DFL
10L x1 Bottle 10L x1 Bottle
1.5L x2 Carton - -
SULFOLYSER
Hemolytic 500mL x3 Bottle 500mL x3 Bottle
agent 4L x2 Carton 5L x1 Bag-in-box
Lysercell WDF
2L x1 Bottle 2L x1 Bottle
42mL x2 Cartridge 42mL x2 Cartridge
Fluorocell WDF
Dye 22mL x2 Cartridge 22mL x2 Cartridge
Fluorocell RET 12mL x2 Cartridge 12mL x2 Cartridge
Detergent CELLCLEAN AUTO 4 mL Vial 4 mL Vial

Note: Diluent prepared from CELLPACK DST using the reagent unit can also be used.

1.3.3 Control blood, calibrator, and linearity check reagent

Control blood : XN CHECK
Control blood body fluid : XN CHECK BF
Calibrator : XN CAL (including sensitivity calibration)
Linearity check reagent : RANGE CHECK X III

XN-L S/M 1-4 November 2016

1.3.4 Interfaces with other devices

External interfaces
LAN ports x2
USB ports x4
External monitor port (VGA) x1
RS-232C port x1
Waste tank full sensor port x1
Pneumatic unit control port x1

1.3.5 Pneumatic unit

A pump capable of producing positive and negative pressure is built into the unit.
An external pneumatic unit (PU-17) can be connected as an option.

1.3.6 System expandability (peripheral devices)

Optional products are as follows.
GP/LP printer
Waste tank full sensor
Hand-held barcode reader
Pneumatic unit (PU-17)

1.3.7 System expandability (software)

McAfee Embedded Security can be installed.

XN-L S/M 1-5 November 2016

1.4 Performance

1.4.1 Intended use

1.4.1.1 Intended use
This instrument analyzes CBC and DIFF in human blood to which an anticoagulant has been added.
Anticoagulants are EDTA-2K, EDTA-3K, and EDTA-2Na Anticoagulant quantities are as stipulated
in CLSI.
As options, RET-related parameters, low WBC, and body fluid can be analyzed.

1.4.2 Analysis principles

1.4.2.1 Blood quantification method
Pipetting technique using a syringe

1.4.2.2 WBC analysis

The sample for WBC analysis is injected into the center of the sheath flow in the flow cell using a
syringe injector.
The forward scattered light and lateral scattered light from a fixed volume of sample is measured
by means of the flow cytometry method using a semiconductor laser, and the count is determined
by automatic fractionation.

1.4.2.3 DIFF analysis

The sample for DIFF analysis is injected into the center of the sheath flow in the flow cell using a
syringe injector.
The lateral scattered light and lateral fluorescent light from a fixed volume of sample is measured
by means of the flow cytometry method using a semiconductor laser, and the count is determined
by automatic fractionation.

1.4.2.4 RET / PLT-O analysis

The sample for RET analysis is injected into the center of the sheath flow in the flow cell using a
syringe injector.
The forward scattered light and lateral fluorescent light from a fixed volume of sample is measured
by means of the flow cytometry method using a semiconductor laser, and the count is determined
by automatic fractionation.

1.4.2.5 RBC / PLT-I analysis

The sample for RBC / PLT-I analysis is injected into the center of the sheath flow using a syringe injector.
A fixed volume passes through a fine hole component and the count is determined by the automatic
discriminator method using sheath flow DC detection.

1.4.2.6 HGB analysis

The light absorption value of light passing through the diluent is measured each time analysis is
performed, and that value is subtracted from the light absorption value of light passing through the
sample for HGB analysis to obtain the HGB value (colorimetric method). The analysis method is
the SLS-Hb method.

XN-L S/M 1-6 November 2016

1.4.3 Analysis parameters and displayed items
1.4.3.1 Analysis mode
Aspiration volumes and required blood volumes by analysis mode
XN-550, XN-530, XN-450, XN-430 ✓: Equipped, -: Not equipped

Required
Equip Aspiration
blood
ped volume
volume
Sampler analysis ✓ Approx. 25 µL Approx. 1 mL
Sampler analysis
✓ Approx. 25 µL Approx. 250 µL
(Raised bottom tube)
Whole blood mode Manual analysis ✓ Approx. 25 µL Approx. 1 mL
Low WBC mode
(Count time twice as long on WDFch Manual analysis
✓ Approx. 25 µL Approx. 250 µL
only) (Raised bottom tube)
Micro analysis ✓ Approx. 25 µL Approx. 0.3 mL
Micro analysis
✓ Approx. 25 µL Approx. 100 µL
(Micro tube)
Sampler analysis - - -
Manual analysis - - -
Approx. 0.3 mL
Dilution mode (x7 dilution) Micro analysis ✓ Approx. 70 µL
(After dilution)
Micro analysis Approx. 140 µL
✓ Approx. 70 µL
(Micro tube) (After dilution)
Sampler analysis - - -
Manual analysis ✓ Approx. 70 µL Approx. 1 mL
Body fluid mode Micro analysis ✓ Approx. 70 µL Approx. 0.3 mL
Micro analysis
✓ Approx. 70 µL Approx. 140 µL
(Micro tube)

XN-350, XN-330 ✓: Equipped, -: Not equipped

Required
Equip Aspiration
blood
ped volume
volume
Manual analysis ✓ Approx. 25 µL -
Whole blood mode
Low WBC mode Manual analysis
✓ Approx. 25 µL -
(Raised bottom tube)
Dilution mode (x7 dilution) Manual analysis ✓ Approx. 70 µL -
Body fluid mode Manual analysis ✓ Approx. 70 µL -

XN-L S/M 1-7 November 2016

1.4.3.2 Analysis discrete mode and analysis channel
(1) Whole blood mode
XN-550 / XN-530 / XN-450 / XN-430 / XN-350 /XN-330 ✓: Equipped, -: Not equipped

Channels
RBC / PLT HGB WDF RET
1
CBC ✓ ✓ ✓* -
CBC + DIFF ✓ ✓ ✓ -
1
CBC + RET ✓ ✓ ✓ ✓
CBC + DIFF + RET ✓ ✓ ✓ ✓
*1 No fluorescent light signal

(2) Low WBC mode (count time in WDF channel only of whole blood mode is doubled.)
XN-550 / XN-530 / XN-450 / XN-430 / XN-350 / XN-330 ✓: Equipped, -: Not equipped

Channels
RBC / PLT HGB WDF RET
CBC + DIFF ✓ ✓ ✓ -
CBC + DIFF + RET ✓ ✓ ✓ ✓

(3) Dilution mode

XN-550 / XN-530 / XN-450 / XN-430 / XN-350 /XN-330 ✓: Equipped, -: Not equipped

Channels
RBC / PLT HGB WDF RET
CBC ✓ ✓ ✓*1 -
CBC + DIFF ✓ ✓ ✓ -
CBC + DIFF + RET ✓ ✓ ✓ ✓
*1 No fluorescent light signal

(4) Body fluid mode

XN-550 / XN-530 / XN-450 / XN-430 / XN-350 /XN-330 ✓: Equipped, -: Not equipped

Channels
RBC / PLT HGB WDF RET
✓ - ✓ -

1.4.3.3 Analysis parameters and display items

Refer to Appendix 1

1.4.3.4 Size of RBC aperture/nozzle and FCM flow cell/nozzle

RBC Detector Block RBC Detector Block FCM Detector Block FCM detector Block
aperture nozzle flow cell nozzle

75μm [AB](diameter) 0.2mm (diameter) 0.25mm (squared) 0.2mm (diameter)

2016051 [AB]2016021

XN-L S/M 1-8 November 2016

1.4.4 Analysis ranges and display ranges
Refer to Appendix 1

1.4.5 Reproducibility
Reproducibility is as specified in Appendix 1 when fresh blood (IG uses a sample with immature granulocytes
(same day blood); RET-He uses a sample with an RET# of at least 2.0x104/µL (same day blood)) or control
blood is analyzed at least 10 times in succession with a reliability having a coefficient of variation of 95%.
However, for the following parameters and analysis modes, analysis is performed using the method indicated.

Parameter Method
For fresh blood, analysis is performed at least 5 times in succession using an
IG%, IG#
abnormal sample with the indicated cells (due to the fact that there are limitations on
HFLC%, HFLC#
the sample volume of abnormal samples).

1.4.6 Accuracy
1.4.6.1 Blood cell count parameters
Whole blood / dilution mode (WBC, RBC)
When at least 100 samples of same-day fresh blood are analyzed after instrument calibration,
the average values are within the ranges in Appendix 1 when compared to analysis using an XN
series standard instrument equivalent.

Body fluid mode (WBC-BF, RBC-BF)

When at least 50 samples of body fluid are analyzed after instrument calibration, the results are
within the ranges in Appendix 1 when compared to the correlation factor and slope of the
regression line of analysis using an XN series standard instrument equivalent or visual analysis.

1.4.6.2 Hemoglobin (HGB)

Whole blood / dilution mode
When at least 100 samples of same-day fresh blood are analyzed after instrument calibration,
the average values are within the ranges in Appendix 1 when compared to analysis using an XN
series standard instrument equivalent or the International Standard Method*.
*HGB standard analysis method using the cyanmethemoglobin method in accordance with the
ICSH (International Committee of Standardization in Haematology) advisory.

1.4.6.3 Hemacrit (HCT)

Whole blood / dilution mode
When at least 100 samples of same-day fresh blood are analyzed after instrument calibration,
the average values are within the ranges in Appendix 1 when compared to analysis using an XN
series standard instrument equivalent or the International Standard Method*.
*HGB standard analysis method using the micro-hemotocrit method in accordance with the
ICSH (International Committee of Standardization in Haematology) advisory.

XN-L S/M 1-9 November 2016

1.4.6.4 Differential blood count parameters
Whole blood / dilution mode (NEUT%, LYMPH%, MONO%, EO%, BASO%, IG%)
When at least 100 samples (for IG, at least 20 samples) of same-day fresh blood (IG uses
samples with immature granulocytes) are analyzed, the correlation factors are within the ranges
in Appendix 1. The reference data are obtained by the FCM standard analysis method using an
XN series standard instrument equivalent, or based on General Procedure MU298001
(standard analysis method for 5 types of WBC and imature granulocytes)
In addition, when compared to analysis using an XN series standard instrument equivalent, the
average values are within the ranges in Appendix 1.
Body fluid mode (MN#, PMN#, MN%, PMN%)
When at least 50 samples of body fluid are analyzed, the results are within the ranges in
Appendix 1 when compared to the correlation factor and slope of the regression line of analysis
using an XN series standard instrument equivalent or visual analysis.

1.4.6.5 Reticulocyte parameters (RET#, RET%, LFR, MFR, HFR, IRF, RET-He)
When at least 100 samples of same-day fresh blood are analyzed after instrument calibration, the
correlation factors are within the ranges in Appendix 1. The reference data are obtained using an XN
series standard instrument equivalent or the visual method (CLSI H44-A2). In addition, when compared
to analysis using an XN series standard instrument equivalent, the average values are within the ranges
in Appendix 1.

1.4.7 Linearity
At the concentration specified in Appendix 1, residuals and residual rates must be within the range
indicated in Appendix 1.

1.4.8 Carryover
As indicated in Appendix 1

1.4.9 Stability
Stability values obtained using the standard analysis method are specified below. Changes in the sample
itself are not included.

1.4.9.1 Temperature stability

When fresh blood and control blood are tested using the standard analysis method, changes are
within the range indicated in Appendix 1. The range of temperature variation is 15 to 35°C for both
reagents and the instrument.

1.4.9.2 Temporal stability (changes during day)

When control blood is tested using the standard analysis method, changes are within the range
indicated in Appendix 1.

XN-L S/M 1-10 November 2016

1.4.9.3 Temporal stability (daily changes)
When control blood is tested using the standard analysis method, changes are within the range
indicated in Appendix 1.

1.4.9.4 Voltage stability (voltage changes)

When control blood is tested using the standard analysis method, changes are within the range
indicated in Appendix 1.

1.4.9.5 Temperature cycle testing

Control blood is analyzed 10 times in succession before and after testing, and average values are
calculated. The differences (absolute value) between the pre-test values and the post-test values
must be within the ranges indicated in Appendix 1.

1.4.9.6 Temporal stability (temporal stability of blood sample after collection)

Changes of fresh blood of a healthy human* must be within the ranges indicated in Appendix 1.
*Applicable samples for IG are same-day blood in which cells of each type appear.

1.4.10 Sample throughput

Sample throughput can be upgraded by means of a software license key.
Standard throughput is about 60 samples per hour. A throughput of 70 samples per hour is possible as an
option (license key).
When barcodes are read on a sampler analysis type, additional time is required for barcode reading.

Open/closed
Whole blood mode (sampler analysis, manual analysis, micro (open) analysis)
XN-550 /530 / 450 / 430 / 350 / 330
CBC Approx. 60 samples/hour
CBC + DIFF (Option: Approx. 70 samples/hour)
CBC + RET
Approx. 35 samples/hour
CBC + DIFF + RET

Pre-Dilution mode
XN-550 /530 / 450 / 430 / 350 / 330
CBC
Approx. 55 samples/hour
CBC + DIFF
CBC + DIFF + RET Approx. 30 samples/hour

Low WBC mode

XN-550 /530 / 450 / 430 / 350 / 330
CBC + DIFF Approx. 55 samples/hour
CBC + DIFF + RET Approx. 30 samples/hour

Body fluid mode

XN-550 /530 / 450 / 430 / 350 / 330
Approx. 30 samples/hour

2015057

XN-L S/M 1-11 November 2016

1.4.11 Reagent volumes
Refer to Appendix 3

1.5 Traceability
Refer to Appendix 1

1.6 Noise
No more than 60 dB. However, the following sounds are excluded.
• Sample tube clamping and release sounds
• Alarm sounds

1.7 Exterior view, dimensions, and weight

Dimensions (width x depth x height mm)

Weight
(including covers)
Instrument:
Instrument: Approx. 450 x 660 x 450
XN-550/XN-530 Approx. 53 kg
LCD: Approx. 270 x 205 x 240
LCD: Approx. 3 kg
XN-450/XN-430 Approx. 450 x 460 x 440 Approx. 35 kg

XN-350/XN-330 Approx. 450 x 460 x 510 Approx. 35 kg

1.8 Usage conditions

1.8.1 Environment
Ambient temperature :15 to 35°C
Relative humidity :20 to 85%[AL]
Atmospheric pressure :70 to 106 kPa (70 kPa is equivalent to an elevation of 3,000 m)
Installation site : Avoid direct sunlight, dust, vibration, and acidic environments.

1.8.2 Power supply

• Voltage :AC 100 to 240 V
• Frequency :50 Hz / 60 Hz
• Power consumption
XN-550/530 XN-450/430 XN-350/330 TM104-SYX01*
100 to 240 V 100 to 240 V 100 to 240 V 100 to 240 V
50 Hz / 60 Hz 250 VA 235 VA 235 VA 36 VA
*TM104-SYX01 : LCD touch panel monitor for XN550/530 only
[AL]315E035

XN-L S/M 1-12 November 2016

1.8.3 Laser class
Class I (IEC60825-1)

1.8.4 Protection type

Class I equipment

1.8.5 Usable reagents

Refer to 1.3.2 Reagents.

1.8.6 Heat generation [AJ]

Calculated by maximum power consumption. Following values are theoretical maximum value. Actual values
will be smaller than those values.

XN-550: Approximately 853 BTU/h

XN-550 Monitor Display: Approximately 122 BTU/h
XN-450/350: Approximately 802 BTU/h

1.9 Operation and usage methods

1.9.1 Test container

1.9.1.1 Regular sample tubes
Height: 70 to 85 mm (including cap), Diameter: 11 to 15 mm (not including cap)
Regular sample tubes tested for operation

Name Remarks
VENOJECT II (Terumo) Reusable caps cannot be used
Hemoguard (BD)
VACUETTE (greiner)
Monovette (SARSTEDT)

1.9.1.2 Micro tubes

Micro tubes tested for operation

Name Remarks
CAPIJECT (Terumo)
Microtainer 365973 (BD)

[AJ] 2015056

XN-L S/M 1-13 November 2016

1.9.1.3 Raised Bottom Tube (RBT)
Raised bottom tubes tested for operation

Name Remarks
Manual analysis and sampler analysis are
Microtainer MAP 363706 (BD)
possible

1.9.2 Types of analysis

1.9.2.1 Manual analysis
Sample tubes are loaded individually by hand. The samples are also mixed by hand. Use this
method for STAT sample analysis, and for analyzing special samples.

(1) Micro analysis

(2) Body fluid analysis
(3) RBT Analysis
1.9.2.2 Sampler analysis
Sample tubes are loaded into a rack, and automatically transported and analyzed. Up to 20
samples can be loaded at once.
To use raised bottom tubes in sampler analysis, place the tubes in the special sampler adapter for
raised bottom tubes (RBT sampler adapter).

1.9.3 Maintenance sequence

• Automatic rinsing (background check)
Background analysis is performed, and if the results are not within the ranges in the table below,
background analysis is extended.
Background analysis is extended a maximum of 2 times (background check analysis is performed a
maximum of 3 times), and if the final results are not within the ranges, a background check error
occurs.

Background check level

Parameter Range
WBC-C 1.0x102 / µL or less 2016020

WBC-D 0.1x103 / µL or less

RBC-I 0.02x106 / µL or less
HGB 1 g/L or less
PLT-I 10x103 / µL or less
PLT-O 10x103 / µL or less
• Reagent replacement sequence
• Flowcell rinse sequence
• Flowcell foam removal sequence
• RBC detector clog removal sequence
• Sample aspiration syringe operation test
• Sheath syringe operation test
• Sampler test sequence
• Hand operation test

XN-L S/M 1-14 November 2016

etc.

XN-L S/M 1-15 November 2016

1.10 Reliability

1.10.1 Expected Design life

Life :5 years
Standard sample throughput :40 samples/day
Design life :40 samples/day x 300 days/year x 5 years = 60,000 samples

1.11 Maintainability (serviceability)

1.11.1 Parts replaced regularly and regular maintenance

Maintenance item
Person
Item Maintenance frequency Method
responsible
Once every 2 years or after every 30,000
Pump Replace User
analyses

Regular maintenance items

Maintenance Maintenance Person
Method
task frequency responsible
Startup Once a day Automatically executed when instrument is started User
Automatically executed when shutdown is selected
Shutdown Once a day from the menu. User is prompted to perform regular User
rinsing if the regular rinsing period is exceeded.
Performed automatically when regular rinsing is
Once a week
selected from the menu, CELLCLEAN AUTO is
or
Regular rinsing placed in the sample holder or in the aspiration User
Once every
pipette, and the manual analysis start switch is
1000 analyses
pressed.

1.12 Storage and transportation conditions

1.12.1 Storage conditions

Ambient temperature :-10 to 60°C
Relative humidity :10 to 95% (no condensation)
Atmospheric pressure :70 to 106 kPa

XN-L S/M 1-16 November 2016