Phoenix NCC 1211

Phoenix NCC-1211
HEMATOLOGY ANALYZER
OPERATION MANUAL
NeoMedica DOO
NeoMedica DOO
Street: Cara Konstantina 82-86, 18000 Niš, Serbia
Tel: (+381) 18 573 820; (+381) 18 573 822; (+381) 18 533 935
Fax: (+381) 18 573 616
Contents
Contents
FULLY AUTO HEMATOLOGY ANALYZER ...................................................................... I
OPERATION MANUAL ......................................................................................................... I
NEOMEDICA DOO ................................................................................................................ I
CONTENTS .................................................................................................................................. I
COPYRIGHT AND STATEMENT ......................................................................................... i
HOW TO USE THE MANUAL ............................................................................................... 1
SAFETY NOTICE .................................................................................................................... 3
OPERATION NOTICE ........................................................................................................... 5
CHAPTER 1 INSTRUMENT INTRODUCTION ............................................................... 6
1.1 NAME ........................................................................................................................ 6
1.2 STRUCTURE ............................................................................................................ 6
1.3 PURPOSE .................................................................................................................. 6
1.4 SPECIFICATION ..................................................................................................... 7
1.5 STRUCTURE .......................................................................................................... 11
1.6 OPERATION .......................................................................................................... 13
1.7 DETECTION PRINCIPLES ................................................................................. 19
CHAPTER 2 INSTALLATION ............................................................................................. 23
2.1 PACKING................................................................................................................ 23
2.2 UNPACKING .......................................................................................................... 23
2.3 INSTALLATION REQUIREMENTS .................................................................. 23
2.4 REAGENT TUBING CONNECTION .................................................................. 24
2.5 RECORDER PAPER INSTALLATION .............................................................. 26
2.6 KEYBOARD AND MOUSE INSTALLATION ................................................... 26
2.7 PRINTER INSTALLATION (OPTIONAL) ........................................................ 27
2.8 POWER CABLE CONNECTION ........................................................................ 27
CHAPTER3 SAMPLE ANALYSIS ...................................................................................... 28
3.1 PREPARATION BEFORE STARTUP ................................................................ 28
3.2 STARTUP ................................................................................................................ 28
3.3 BACKGROUND TEST .......................................................................................... 29
3.4 QUALITY CONTROL ........................................................................................... 30
3.5 PREPARATION FOR SAMPLE COLLECTION .............................................. 30
3.6 SAMPLE COUNT AND ANALYSIS .................................................................... 33
3.7 ANALYTICAL RESULTS MODIFICATION .................................................... 36
CHAPTER 4 QUALITY CONTROL ................................................................................... 38
4.1 L-J QUALITY CONTROL EDIT ......................................................................... 38
4.2 L-J ANALYSIS ....................................................................................................... 40
4.3 L-J CHART VIEW ................................................................................................. 41
V15.04.19
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Contents
4.4 L-J QUALITY CONTROL LIST VIEW .............................................................. 42
CHAPTER 5 CALIBRATION .............................................................................................. 44
5.1 MANUAL CALIBRATION ................................................................................... 44
5.2 AUTO CALIBRATION ......................................................................................... 47
9.6 MAINTENANCE BEFORE TRANSPORT OR FOR THE INSTRUMENT

THAT WILL NOT BE USED FOR A LONG TIME ............................................................ 91
II
V15.04.19
Contents
ANNEX 2: TOXIC MATTER OR ELEMENTS NAME AND CONTENT ........................ 97
ANNEX 3: SUPPORTED EXTERNAL PRINTER ............................................................. 98
V15.04.19 III
Copyright and statement
COPYRIGHT AND STATEMENT
COPYRIGHT
Copyright ©NeoMedica DOO , all rights reserved.
Thank you for choosing our instrument. The Phoenix NCC-1211 Hematology Analyzer Operation
Manual would bring you the best experience and conveniences.
NeoMedica DOO owns all the copyright of Phoenix NCC-1211 Hematology A nalyzer
Operation Manual. Without expressly authorized by NeoMedica DOO, anybody or company can
not duplicate, copy, translate, or disclose this manual in any form.
This manual includes the newest information up to printing. NeoMedica DOO reserves the right
of changing the content of this manual without prior notice.
Part of the graphics in this manual is only sketch maps, using solely for the purpose of reference.
If the graphic is not consistent with the physical object, subject to the physical object.
STATEMENT
Phoenix NCC-1211 Hematology Analyzer Operation Manual involves the agreement
for right and obligation coming into being and termination in product quality warranty
and service between NeoMedica DOO and user.
User must read this manual carefully and strictly operate the instrument according to
this manual. The obligation of NeoMedica DOO does not include any
malfunction or error resulting from improper operating the instrument.
Upon request, NeoMedica DOO may provide, with compensation,
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necessary circuit diagrams and other information to help qualified technician to
maintain and repair some parts, which NeoMedica DOO may define as user serviceable.
QUALITY WARRANTY:
NeoMedica DOO guarantees new equipment other than accessories to be free from defects
in workmanship and material for a period of one year from date of shipment under normal use
and service.
The obligation of NeoMedica DOO under this warranty is only cost-free maintenance,
namely including the man-hour and material charges, but not the losses and
additional charge resulting from stopping using the instrument. Illustrate as follows:
Freight charges (including customs charges and insurance).
Related losses caused by the instrument can not be used normally.
The obligation of NeoMedica DOO does not include the following situations
caused by direct, indirect or consequential damages and delay:
Improper use.
Maintain the instrument out of accordance with maintenance regulations.
Use the reagent or accessories not provided or authorized by NeoMedica DOO
Replace accessories unauthorized by NeoMedica DOO or personnel
unauthorized by NeoMedica DOO repairs or modifies the instrument.
AFTER SERVICE
We have competent and experienced customer service department. If you have any problem or
advice, please contact us.
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CUSTOMER SERVICE INFORMATION:
NeoMedica D.O.O.
Address: street Cara Konstantina 82-86, 18000 Niš, Serbia
Tel.: +381 (18) 573-820, +381 (18) 573-822, +381 (18) 533-935
Fax: +381 (18) 573-616
Email: servis@neomedica.rs
Web: www.neomedica.rs
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How to use the manual
HOW TO USE THE MANUAL
You are welcome to read this manual. This manual includes the in-depth information about
installation, daily operation, calibration, quality control and maintenance. To achieve the optimal
performance, be sure to operate and maintain the instrument according to this manual. If you has
chosen the optional accessories such as printer, bar code scanner, read the related manuals of
those.
The data in this manual has been calibrated and is efficient. If the instrument is used for a special
purpose, or the operational procedures/methods exceed the regulation of this manual, please
contact with NeoMedica DOO to inquire its validity and applicability. Otherwise NeoMedica DOO
will not be able to ensure the accuracy and validity of the measuring results,
and will not perform any obligation for the direct or indirect results resulting from this action.
AVOIDANCE FROM POTENTIAL HAZARD:
User should read the “Safety Notice” and “Operation Notice” carefully.
There are several safety warning signs in this manual to help operators avoid hurting themselves
or making the instrument damaged, resulting in incorrect measuring results:
Warning: The instrument must be operated as the operating procedures, or else, there
will be great hazards to both operator and environment.
Caution: Emphasize the operating methods that must be obeyed. Avoid potential
hazards or making the instrument damaged, resulting in incorrect measuring results.
1
How to use the manual
Notice: To emphasize important information.
All personnel that may operate, maintain, remove, service the instrument should read this manual
carefully.
Hereinafter called Phoenix NCC-1211 hematology analyzer as instrument.
Hereinafter called NeoMedica DOO as NeoMedica.
2
Safety notice
SAFETY NOTICE
To operate the instrument safely and effectively, be sure to read the following notices first.
Operating the instrument, without following the appointed methods by the manufacturer, may
break down the defensive function of the system, and cause bodily injury or damage the
instrument.
Avoid electric shock
(1) When the power-on, the unauthorized maintenance personnel should not open the
instrument.
(2) If liquid enters into the instrument or the instrument leakage, please shut off the
power immediately, and contact with NeoMedica Customer Service Department or
local distributor in due course. Improper use of the liquid may cause electric shock
and result in damaging the instrument.
Defence for biohazrd and chemical hazards
Improper use of the sample may result in being infected.
Avoid touching sample, reagent and waste with hands directly. When operate the instrument,
be sure to wear gloves to avoid being infected.
If skin contacts the sample, manage it according to operator working standard or inquiring a
doctor to take remedial measures immediately.
Use the reagent carefully to avoid hand and clothes touch directly.
Once hand or clothes touch, flush the touched area with soap and plenty of water immediately.
If the reagent enters into the eyes incautiously, flush with plenty of water at once, and inquire
a doctor for further treatment.
Waste disposal
Reagent, quality control serum and some materials in the sample are controlled by pollution
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Safety notice
regulations and standard for discharge of pollutants. Please abide by the local discharge
regulation and inquire related reagent manufacturers.
Prevention of fire and explosion
Be sure not to use flammable dangerous materials around the instrument.
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Operation notice
OPERATION NOTICE
To operate the instrument safely and reliably, be sure to obey the following notices.
Purpose
Pay attention to the application range of the instrument statement. Make sure your use does
not exceed the application range.
Limitation of operating environment
The instrument should be installed according to the required installation environment
of the manual. Installation and use out of the appointed range may cause unreliable
results, and make the instrument damaged.
Contact with NeoMedica Customer Service Department or local distributor if you need
to change the state of the instrument.
Limit of operator
Only trained and authorized personnel by the manufacturer can operate the instrument.
Maintenance and service
Be sure to service and maintain the instrument according to this manual strictly.
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Chapter 1 Instrument Introduction
CHAPTER 1 INSTRUMENT INTRODUCTION
1.1 NAME
The full name of the instrument is NCC-1211 fully auto hematology analyzer.
1.2 STRUCTURE
Host and accessory.
1.2.1 Host
Control the process of sample collection, dilution and analysis, including the following units:
1. Power supply unit.
2. Central control circuit unit.
3. Dilute unit.
4. Volume measuring unit
5. Display unit.
6. Thermal recorder.
1.2.2 Accessory
Including the following accessories:
1. USB mouse.
2. USB keyboard.
3. Printer (optional).
1.3 PURPOSE
It is used for detecting the parameters of RBC, WBC, HGB and differential counter.
The analyzer is used for the determination of the following 20 parameters and 3 histograms blood
specimens in Table 1-1.
FULL NAME ABBREVIATION UNIT
WHITE BLOOD CELL WBC 109/L
Lymphocyte LYM% %
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Mid-sized Cell Percentage MID% %
Mid-sized Cell GRAN% %
RED BLOOD CELL RBC 1012/L
Hemoglobin Concentration HGB g/L
Mean Corpuscular Volume MCV fL
Platelet PLT 109/L
Table 1-1
1.4 SPECIFICATION
Standard Classification of the Instrument
According to anti-electrical shock hazard: Grade II, Pollution 2
According to the defence for deleterious liquid: General Device (Closing device of
non-defensive liquid).
According to the recommended disinfection/sterilization method of the manufactory:
Disinfectant device recommended by manufactory.
According to safety degree in condition that using gas mixture of flammable anesthetic
gas and air or gas mixture of oxygen and nitrous oxide: Do not use the equipment in
condition that using gas mixture of flammable anesthetic gas and air or gas mixture of
oxygen and nitrous oxide.
According to working status: Continuous Running Equipment.
Design lifecycle: 8 years
Principles of Measurement
Blood cells are counted and sized by Electrical Impedance Method. Hemoglobin is
determined by Colorimetry Method.
Parameters of Measurement Basic Parameters:
Calculated from Histograms:
Calculated Parameters:
Sampling Features:
Sample Volume:
Venous Blood Mode: 9.6μL Venous Blood
Capillary Blood Mode: 9.6μL Capillary Blood
Prediluted Mode: 20μL Capillary Blood
Reagent Volumes Required for Single Sample:
Diluent: 20mL
Cleaner: 4.8mL
Lyse: 0.4mL
Venous and Capillary Blood Mode: WBC/HGB 1:300
RBC/PLT 1:44600
Prediluted Mode: WBC/HGB 1:355
RBC/PLT 1:44500
Cell Counting Aperture Size:
WBC: 100μm
RBC: 80μm
Display
Liquid Crystal Display (LCD),resolution:800×600
Language
English
Indicator
20 Parameters and 3 Histograms Display
Alarm Indicator
Working Status (including Power) Indicator Light
Alarm
Interface
One power input socket
One VGA display port
One RS-232 serial ports
Four USB interfaces
One Ethernet port
Recorder
Rapid Thermal Recorder
Recording width: 48mm
Paper width: 57.5mm
Precision Specifications of the Instrument
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Parameter Repeatability (CV %)
WBC ≤2.5%
RBC ≤2.0%
HGB ≤2.0%
MCV ≤1.0%
PLT ≤6.0%
Linear Range
Parameter Range
WBC 0.0-99.9x109/L
RBC 0.00-9.99x1012/L
HGB 0-300g/L
MCV 40 - 150fL
PLT 10-999x109/L
Screen Display and the Ranges for Report Output Parameters
Parameter Parameter range Parameter Parameter range
WBC 0.0 - 99.9x109/L GRAN# 0 - 99.9x109/L
RBC 0.00 - 9.99x1012/L HCT 0.0 - 100.0%
HGB 00.0 - 300g/L MCH 0.0 - 999.9pg
PLT 0 - 3000x109/L MCHC 0.0 - 999.9g/L
MCV 0 - 250fL RDW-SD 0.0 - 99.9 fL
LYM% 0 - 100% RDW-CV 0.0 - 99.9%
MID% 0 - 100% PDW 0.0 - 30.0%
GRAN% 0 - 100% MPV 0.0 - 30.0fL
LYM# 0 - 99.9x109/L PCT 0.0 - 9.99%
MID# 0 - 99.9x109/L P-LCR 0.0-99.9%
Operating Ambient Temperature: 15℃~35℃
Humidity: 10~90%
Atmospheric Pressure: 86.0kPa ~106.0kPa
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Ambient Storage
Temperature: -10℃~40℃
Humidity: ≤80%
Atmospheric Pressure: 50.0kPa ~106.0kPa
Electric Specifications
Power Supply: AC 100～240V, 50±1Hz,
The maximum input consumption is 150VA
Fuse: AC T3.15AL 250V
Dimensions and Weight
Dimensions: 325mm×380mm×430mm
Weight: 23kg
1.5 STRUCTURE
1.5.1 Front Panel
① --- Thermal Recorder
② --- Display Screen
③ --- Sample Needle
④ ---[START] Key
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1.5.2 Rear panel
Figure 1-2
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①---Grounding rid ②---RS-232 serial port
③--- Ethernet Interface ④---USB port( Keyboard, mouse, Printer)
⑤---VGA port ⑥---Air Filter
⑦--- WASTE Sensor Connector ⑧--- WASTE Connector
⑨--- CLEANER Connector ⑩--- DILUENT Connector
⑾--- LYSE Connector ⑿---Fuse Holder
⒀--- Socket for Power input ⒁--- Power Switch
1.6 OPERATION
Designed according to human engineering and transferring information to users by software , display
and mouse, keyboard, both are convenient for your operating.
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1.6.1 Display Screen
The display screen is classified five sections:
FUNCTION TAB
MAIN DISPLAY WINDOW
AULILIARY INFO TIPS AREA SYSTEM TIME AREA
AREA SPEAKER
Figure 1-3
SYSTEM TIME and SPEAKER SECTION
Display the current date and time of the system, SPEAKER STATUS
TIPS SECTION :
Display prompt information of the system.
FUNCTION TAB:
Display various function tab
MAIN DISPLAY WINDOW:
Display various analyzing results
AUXILIARY OPERATION SECTION
Display the information of user and sample
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1.6.2 UI Structure
User can access all function of analyzer by move mouse cursor or finger tip above button,
then click or finger push.
Click <Back> button to quit
For Main UI
： Enter Function tab
： Input sample and patient information for next sample
： Enter histogram adjust window for current sample, user can manual
adjust Histogram
： Under Venous and Capillary mode, this button can prime diluents
into tube.
Under pre-diluent mode, adding diluents
Print out test result to printer
Select sample test mode from Venous, Capilliary, Pre-diluent
User can review analysis record in detail, edit, delete, inquiry, print,etc
L-J QC control: Enter L-J QC function tab
Calibrate the analyzer
Service, enter service function tab
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Setting, enter setting function tab
Review selected record in detail
Delete selected record
Find, inquiry record with input condition
Select record in range with input start and end
Print out selected record
CV%：Enter CV% calculation
： Edit QC parameter
： Select QC file to analysis and running
： View L-J QC in chart
： View L-J QC in list
Manual calibration
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Auto calibration
View analyzer information
Upgrade analyzer
Review operation history in log
Access engineering function as below
CLOG ：Clean general clog
Clog Enhanced clean clog
Clean Normal clean analyzer
Clean Enhanced clean analyzer
Prime Click to prime diluent
Prime Click to prime lyse
Prime Click to prime cleaner
Maintenance Running maintenance process for analyzer
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Drain the liquid out of chamber
Reset all step-motor to original position
Running park process, suit for long-time no use or transportation
Self-Detection for PCBA, valve, interface
（Only available under factory mode）。
View help file
Set user
Set below for analyzer
set reference range
Reference unit
Set lab and hospital information
Setting information for doctor and sender
Entering print setting
Entering communication setting
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System Language selection
Choose skin setting
Set date/time
Set interval for auto-clean and auto-maintenance
Switch working mode
Restore factory default
Shutdown： Entering shutdown procedure
1.7 DETECTION PRINCIPLES
1.7.1 Detection Principles of WBC, RBC and PLT
The count principle of the instrument is based on the measurement of changes in electrical
resistance produced by a particle passing through an aperture sensor.
a) The sample blood is diluted in a conductive liquid. As blood cells are non-conductive, the
diluent is a good conductor. There are big differences between them.
b) When the diluent passes through the aperture sensor, electrodes are submerged in the liquid
on each side of the aperture to create continuous current.
c) When cells pass through the aperture, the resistance between the electrodes increases as the
cell volume increasing, as shown in figure 1-4.According to the Ohm Formulary: U=RI
(U=Voltage I=Current R=Resistance).If I is a constant, U increases as the cell volume
increasing.
d) Passing through the magnification circuit, the voltage signal will be magnified and the
noise will be filtered, then you will gain the analytical results, as shown in figure 1-54
e) One count bath and the detection circuit count the WBC. Another count bath and the
detection circuit count the RBC and PLT. The microprocessor of the instrument calculates and
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analyzes the cells (WBC, RBC and PLT), and then gives out the histograms.
f) PLT count adopts advanced liquid, electronics and software system. It settles the repetitive
count of the cells on the side of the aperture count area.
Figure 1-4
1.7.2 Principles of HGB Measurement
Adding lyse in the blood, the red blood cells will rapidly be broken down and release
hemoglobin. Hemoglobin and lyse form a new mixture, which can absorb the wavelength of
540nm.Measure the absorbency. Through the comparison of the absorbency between the pure
diluent and the sample，the concentration of the sample hemoglobin is calculated.
1.7.3 Volume Distribution of Blood Cells
When different types of cells pass through the aperture sensor, there will be different electrical
pulse height. Because of the evident difference of the cells sizes, the instrument is able to
differentiate the white blood cell, red blood cell and platelet by its pre-set program.
The volume distributions are as follows:
WBC 120～1000fL
RBC 82～98fL
PLT 2～35fL
The leucocytes disposed by lyse can be divided into three types, according to their volumes:
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lymphocyte (LYM), mid-sized cell (MID), Granulocyte (GRAN).
LYM 35～90 fL
MID 90～160 fL
GRAN 160～450 fL
1.7.4 Results and Calculation of Parameter Measurement
The parameters of the sample blood test can be described in three ways:
a) Measured directly, such as WBC, RBC, PLT and HGB.
b) Derived from histograms, such as LYM%, MID%, GRAN%, MCV, RDW-SD,
RDW-CV, MPV, PDW and P-LCR.
c) Calculated, such as LYM#, MID#, GRAN#, HCT, MCH, MCHC and PCT.
The derivation of the formularies as follows:
z MCV derives from histograms and the instrument collecting and classifying the
erythrocytes according to its volume. It is determined by measuring the average volume
of individual erythrocytes, and the unit is fL.
z RDW represents the volume distribution of the erythrocyte populations, derived from
the RBC histogram. It can be expressed by the coefficient variation of the erythrocyte
volume as RDW-CV, and the unit is %.It can also be expressed in standard deviation of
the erythrocyte volume as RDW-SD, the unit is fL.
z MPV is the average volume of individual platelets, derived from the PLT histogram. It
represents the mean volume of the PLT populations and can be expressed in fL.
z PDW derives from the PLT histogram. It represents the geometry standard deviation (10
GSD) of the volume of the PLT populations.
z P-LCR derives from the PLT histogram. It represents the ratio of the larger PLT and the
unit is %.
z HCT(%)= RBC×MCV/10
z MCH(pg)= 10×HGB/RBC
z MCHC(g/L)= 100×HGB/HCT
z PCT(%)= PLT×MPV/10
z LYM%=100×AL/(AL+AM+AG)
z MID%=100×AM/(AL+AM+AG)
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z GRAN%=100×AG/(AL+AM+AG)
z LYM#=LYM%×WBC/100
z MID=MID%×WBC/100
z GRAN#=GRAN%×WBC/100
AL: Number of cells in LYM area;
AM: Number of cells between lymphocyte and granulocyte area;
AG: Number of cells in GRAN area.
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Chapter 2 Installation
CHAPTER 2 INSTALLATION
2.1 PACKING
If packing damage is discovered after receiving the instrument, or the instrument is badly damaged,
contact with the freight agent immediately to file a claim according to the damage level. At the
same time contact with your supplier to make sure the packing is complete. Then unpacking and
installing the instrument as the following steps.
2.2 UNPACKING
Take out the instrument and accessories from the packing case carefully. Preserve the packing
material for future transportation or storage.
a) Check the accessories compared to the packing list.
b) Check whether there are mechanical damages on the instrument and accessories.
c) When moving the instrument, face to the front shell and hold up the bottom of the
instrument with hands and carry it carefully.
If there is any problem, please recovery the packing and contact with your supplier immediately.
2.3 INSTALLATION REQUIREMENTS
2.3.1 Installation Environment
The instrument should be placed on a clean steady room platform. Avoid direct sunlight and dust.
Keep room temperature at 18~35°C, humidity no higher than 70%, atmospheric pressure at
86.0~106.0Kpa.
Caution:
The instrument should avoid direct sunlight.
Caution:
The working environment of the instrument should avoid powerful equipment such as Centrifuge,
CT machine, NMR equipment, X-ray machine etc.
Caution:
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Do not use equipment that may create strong radiation field such as mobile phone and cordless
telephone. Strong radiation field will disturb some functions of the instrument.
2.3.2 Space Requirement
At least 20cm on each side is the preferred access to ensure good airiness.
Notice:
Reagents must be placed at the same working height as the instrument.
2.3.3 Power Requirement
The power requirement as follows:
z AC 100～240V, 50 Hz
z The maximum power consumption is 150VA
Warning:
The instrument requires a single well-grounded power socket. Its grounding voltage is no more
than 0.5V.
Warning:
A grounded outlet is required to connect with the grounding pole on the rear panel. Be sure to
guarantee the reliability of the power grounding at working site.
Caution:
Fluctuating electric will badly decrease the performance and reliability of the instrument. Proper
action such as the installation of UPS (self-preparation) should be taken before use.
2.4 REAGENT TUBING CONNECTION
There are three tube connectors with color of black, green, blue on the rear panel of the instrument.
To avoid tubing contamination, the manufacturer plugs up a cap for each of the connectors before
delivery. Please pull the caps out of the connectors carefully before installation for the first time
and preserve them.
2.4.1 Lyse Connection
Take out the lyse tube with red connector from the accessory kit. Open the cap and horizontally
place it to the left side of the instrument.
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Connect the red lyse tubing connector with the tubing connector of the same color on the rear
panel of the instrument.
Place the other end of the lyse inlet tubing into lyse container, and turn the container cover until
secure
2.4.2 Diluent Connection
Take out the diluent tube with green connector from the accessory kit.
Connect the green diluent tubing connector with the tubing connector of the same color on the rear
Place the other end of the diluent inlet tubing into diluent container, and turn the container cover
until secure.
2.4.3 Cleaner Connector
Take out the cleaner tube with blue connector from the accessory kit.
Connect the blue cleaner tubing connector with the tubing connector of the same color on the rear
Place the other end of the cleaner inlet tubing into cleaner container, and turn the container cover
until secure.
2.4.4 Waste Connector
Take out the waste tube with black connector from the accessory kit.
Connect the black waste tubing connector with the tubing connector of the same color.
Connect BNC plug with BNC socket marked “WASTE” on the rear panel of the instrument.
Turn the waste container cover clockwise until secure.
Caution:
After completing all the tubing installation, keep the tubing natural state, without distortion,
folding, and twist.
Caution:
All the tubing connectors must be installed manually. Forbid using any tool.
Caution:
The reagent must be applied with the instrument. Otherwise it may easily cause inaccurate
measurement results and incorrect classification of the blood cells, or make the tubing system
25
badly damaged.
Caution:
Keep the reagent from direct sunlight.
Caution:
After replacing the reagent container, discard the rest of the reagent in the former container.
Forbid putting the rest of the reagent into the replacing container. Avoid polluting the new
replacing reagent.
Caution:
When replacing the reagent, avoid making the plastic tube (inserted into the reagent container)
contact other things. Avoid polluting the new replacing reagent.
Caution:
Avoid using frozen reagent.
Caution:
Avoid using the reagent out of its expiration date.
Warning:
Handle and dispose of the waste according to acceptable laboratory, local state and national
standards.
2.5 RECORDER PAPER INSTALLATION
a) Tear down the gummed paper from the door of the recorder.
b) Gently press the door of the recorder to open it.
c) Insert the new paper into the paper entry, and make the printing side towards the
thermal head.
d) When the paper juts out from the other side, pull it out and keep it straight.
e) Pull the paper out of the paper exit.
2.6 KEYBOARD AND MOUSE INSTALLATION
Take out the keyboard, mouse cushion and mouse from the packing case carefully.
Plug keyboard cable into the interface marked on the rear panel of the instrument.
Plug mouse cable into the interface marked on the rear panel of the instrument.
The keyboard and mouse can be placed where it is convenient for your operating. We suggest that
26
the keyboard under the display screen of the instrument, the mouse cushion at the right side of the
keyboard, and the mouse on the mouse cushion.
2.7 PRINTER INSTALLATION (OPTIONAL)
Take out the printer from the packing case carefully. Install the printer according to the printer
manual.
Notice:
The printer cable can only be connected with the interface marked on the rear panel of the
instrument.
2.8 POWER CABLE CONNECTION
Make sure the power switch is off (0) on the rear panel of the instrument. Insert one end of the
power cable into the power cable interface on the instrument, the other end into the power socket.
Connect the ground wire to the grounding port on the instrument.
Warning:
Ensure the power is suitable for the instrument before connection.
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Chapter 3 Sample Analysis
CHAPTER3 SAMPLE ANALYSIS
3.1 PREPARATION BEFORE STARTUP
Every time before startup, the operator should do the following checks:
a) Check whether the diluent and waste tubing are distortion, folding, twist, and whether the
connection is secure.
b) Check whether the power cable connection is secure.
c) Check whether the accessory connection is secure.
3.2 STARTUP
If external printer is equipped, turn on the printer power or the bar code scanner power and ensure
they are in ready status.
Press the power button on the rear panel of the instrument, then the power lamp on the front panel
of the instrument lights on. The instrument automatically performs initialization program.
After completing initialization, the instrument will access self-test window. It tests the working
conditions of each part and if there is enough diluent, cleaner and lyse. Simultaneously prime and
clean the tubing.
After self-test, the instrument will access blood cell analyzer window, as shown in Figure 3-1.
If the system detects malfunction, the failure information will be displayed on Information
Section.
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Figure3-1
3.3 BACKGROUND TEST
Background test is recommended after the instrument startup normally every time. The operator
can also perform background test in need. Analyzer will perform blank test during startup every
time, Analyzer will be ready for use after first blank test is passed.
When blank test failed after three tests, analyzer will not be ready for use in a malfunction
warning.
The operating procedures as follows:
a) In the blood cell analyzer window, press “Info” button, and pops up the information edit
window. Then click the item textbox, change the ID from 9000 to 9999.then press “OK”, return
to blood cell analyzer window.
b) In venous or capillary mode, press the “START” key below the sample needle directly for
background count. In prediluted mode, the sample needle aspirates some non-contaminated
diluent from the sample cup for background count. The diluent pick-up method as
29
follows(Analyzing the sample in prediluted mode, it is also necessary to dilute sample with the
diluent which is prior picked-up in this method):
1) Press the right key of mouse in main operation area, pops up the menu. In menu operation
area, select “Sample Mode”; Set up “Prediluted” as the sample mode.
2) Press the upper-right tab <Diluent> in main operation area
3) Place a clean empty sample cup or tube under the sample needle, press “START” key to
dispense the diluent into the sample cup. Press the “START” key once, the diluent is
dispensed into the sample cup or tube once (The quantity can be used for background
count in the second prediluted mode).
4) Press “Exit” button, the instrument return to main operation area
c) The acceptable range of the background test results are shown as table 3-1.
Parameter Value Unit
WBC ≤ 0.2 109/L
RBC ≤ 0.02 1012/L
HGB ≤1 g/L
HCT ≤ 0.5 %
PLT ≤ 10 109/L
Table 3-1
If the value of the background test exceeds the permissive range, repeat the upper testing
procedures until the testing result is acceptable. If the test has been carried on above five times, the
testing result still can not reach the standard required. Please refer to Chapter 10
“Troubleshooting” in this manual.
Notice:
Only five parameters WBC, RBC, HGB, HCT, and PLT can be tested and displayed in
background test.
Notice:
The serial number 9000-9999 is a special reserved number for background test.
3.4 QUALITY CONTROL
It is necessary to perform quality control in installation for the first time or before sample analysis
every day. Further information and procedures are given in Chapter 4 “Quality Control”.
3.5 PREPARATION FOR SAMPLE COLLECTION

30
The sample can be collected either from capillary blood or from venous blood.
Warning:
Avoid directly contacting with the blood sample, control and calibration in any case.
Handle or dispose of these things according to acceptable laboratory or clinical standards.
3.5.1 Venous Blood Collection
It is possible to collect venous blood by using negative pressure tube or in common collecting
method. Add some anticoagulant in advance to the container for venous blood collection.
EDTA.K2.2H2O is commonly used as the anticoagulant, whose specified content is 1.5-2.2mg/ml
blood.
3.5.2 Capillary Blood Collection
Parts for blood collection:

Adult: Middle finger tip inner of the left hand, or ring finger tip inner of the left hand
Child (above six-month-old): Middle finger
Infant (under six-month-old): Outer side of the thumb or foot
Blood collection methods:
1. Gently massage the blood collection part to make it congest naturally, wipe the partial skin
with tampon containing 75% alcohol, then airing it.
2. Pinch the puncturing part, and puncture it with aseptic sample needle quickly. The
puncturing depth is about 2-3mm.
3. Wipe off the first drop of blood, and then start collection
4. Press the wound with tampon for a moment after finishing the collection.
Notice:
The capillary blood collection should follow the professional capillary blood collection
standard. The general method is partial centesis. The typical collection is puncturing from
the tip of the finger.
Caution:
If the blood flows not freely, press far away from the wound, not around the wound. Avoid
making the histiocyte mixed into the blood, resulting in incorrect analytical result.
31
3.5.3 Prepare Samples in Prediluted Mode
In blood cell analyzer window, select “Sample Mode/Prediluted” in operation menu. Then select
“Diluent”. When the “Diluent” pops up, place a clean sample cup obliquely under the probe. Press
“START” key. The instrument starts to add diluent quantificationally. When adding diluent, the
indicator light glimmers quickly. Scrape the drops at the top of the sample needle into the sample
cup when the indicator light glimmers slowly.
Collect 20μL capillary sample in pipette. Wipe the blood attached on the outer layer of the pipette
with clean tissues. Immediately mix up the sample in the diluent sample cup.
Caution:
When adding the diluent, the sample cup must be placed obliquely under the sample needle, which
allows the diluent to run down the cup wall without forming air bubbles.
Notice:
If there is a need to prepare samples in quantities in prediluted mode, user can use the “Diluent”
function to continuously prepare the diluent.
3.5.4 Prepare Samples in Capillary Mode
Collect 20μL capillary sample in pipettes. Immediately mix up the sample in anticoagulated
warhead sample cup. You can also add the capillary blood to the anticoagulated warhead sample
cup directly.
3.5.5 Sample Homogenization
The blood samples must be fully homogenized before use. The recommended method is: Shake up
the tube up and down 3-5 minutes. NeoMedica’s blood mixer is recommended to make the sample
be fully homogenized and ensure the accuracy of measurement.
Caution:
If the sample has been placed for a long time or mixed inadequately, it will easily cause
measurement error and incorrect testing results.
Caution:
Avoid shaking up the pipette violently.
Caution:
The sample to be tested can only be stored at room temperature, and the test must be
finished within 4 hours.
32
3.6 SAMPLE COUNT AND ANALYSIS
After finishing sample collection, perform count and analysis procedure as follows.
3.6.1 Input Sample Information
3.6.1.1 Manual Input Information
In blood cell analyzer window, click “Info” button, pops up information edit window. Move the
32 Sample analysis cursor to the required inputting item textbox. Input or select the data, and press
“OK”. The instrument will save the input information and returns to the blood cell analyzer
window. Pressing “Cancel” key, the instrument cancels the input information and returns to the
blood cell analyzer window.
Sex: Select male or female, and the default is male.
Name: Maximum 12 letters.
Age: Choose from year, month and day. Maximum 3 numbers while choosing year; Maximum 2
numbers while choosing month and day.
Patient ID: Maximum 12 letters.
Bed NO: Maximum 12 letters.
ID: The input range is: 0001-9999. The instrument owns an intelligent number manager. The final
number derives from the comprehensive information that the instrument adds the information of
year, month and day in front of the input number according to the measured time. If user does not
input the serial number, the instrument will accumulate the number from 0001 everyday according
to the measured time.
Sent time: the time sample was sent
Sampling time: The time blood sample was collected
Blood: Choose from A, B, O, AB, Rh +, Rh- . The default is blank.
Sample mode: The current sample mode.
Case Hist: Maximum 12 letters.
Department: Maximum 12 letters. You can also choose the recorded department information
from the right optional textbox, or choose automatically by the instrument after inputting the code
of the department in the left input textbox.
Sender: Maximum 12 letters. You can also choose the recorded sender information from the right
optional textbox, or choose automatically by the instrument after inputting the code of the doctor
in the left input textbox.
Operator: Maximum 12 letters. You can also choose the recorded doctor information from the
right optional textbox, or choose automatically by the instrument after inputting the code of the
33
doctor in the left input textbox.
Inspector: Maximum 12 letters. You can also choose the recorded doctor information from the
right optional textbox, or choose automatically by the instrument after inputting the code of the
doctor in the left input textbox.
Reference group: Choose from general, man, woman, child, baby, define 1, define 2, and define 3,
automatically. While choosing “Auto”, the instrument gives the reference value automatically as
shown in table 3-2.
Remark: User can input additional note here.

Notice:
The serial number 9000-9999 is a special reserved number for background test. Please don't input
this number for blood sample test.
3.6.2 Procedures of Sample Count and Analysis

a) Place a sample cup under the sample needle, press “START” key, the indicator lamp on
the front panel of the instrument begins to glimmer. The instrument starts to absorb the liquid.
Move the sample cup until the indicator lamp stops glimmering.
b) The instrument starts to analyze the sample automatically. Please wait for the analytical
result.
c) After the analysis finished, the result will be displayed in the rear of the corresponding
parameters on blood cell analyzer window of the instrument, with histograms WBC, RBC, and
34
PLT. As shown in figure 3-1.

If “Auto” item is “ON”, the recorder or printer will output the test results automatically.
If there are clogs or bubbles during the count and analysis process, the information section would
display “Clog” or “Bubble”.
3.6.3 Parameter Alarm
“T”: To indicate that the reagent temperature or environment temperature has exceeded the setup
range.
“B”: To indicate that bubble appears in the test.
“C”: To indicate that clog appears in the test.
“L”: To indicate the data has exceeded the setup lower alarm limit of the parameter.
“H”: To indicate the data has exceeded the setup higher alarm limit of the parameter.
“***”: To indicate that the data is invalid.
Notice:
When PM alarm occurs on PLT histogram, the result of parameter PDW is “***”.
Notice:
If the result of WBC is less than 0.5×103/uL, the system will not perform leukocyte
differential. The display for all parameters related to leukocyte differential is “***”.
3.6.4 Histogram Alarm

“R1”: To indicate the abnormality of the lymphocyte hump on the left. It may present platelets
coagulate, large platelet nucleated red cell, insolvable red cell, abnormal lymphocyte, protein etc.
“R2”: To indicate the abnormality between the lymphocyte and the mid-sized cell area. It may
present atypical lymphocyte, abnormal lymphocyte, plasma cell, original cell or the increase of the
number of the eosinophil or basophil.
“R3”: To indicate the abnormality between the mid-sized cell and granulocyte. It may present
immature granulocytes, abnormal sub-population in the sample, or the increase of the number of
the eosinophil.
“R4”: To indicate the abnormality on the right of granulocytes area. It shows the increase of the
number of the granulocyte.
“RM”: To indicate that more than two areas occurs abnormality. The upper reasons exist
simultaneously.
“PM”: To indicate the abnormality the blur demarcation between platelet and red blood cell area.
Large platelet, platelet coagulation, small red blood cell, cell debris or fibrin may exist.
35
3.7 ANALYTICAL RESULTS MODIFICATION

If user thinks that the results of WBC, RBC, and PLT differential can not meet the needs of the
classification of special samples in clinical or laboratory, he can manually adjust the histograms.
Operate as follows:
a) In the blood cell analyzer window, select “Histogram” in Function tab, the instrument
accesses histogram adjustment window, as shown in figure 3-2. Press “Chart” button to
adjust the histogram.
b) After selecting the histogram, press “Line” button, and select the sorting line you want to
adjust.
c) Press “Left” or “Right” button, you can remove the sorting line to the left or right, the data of
the line will be displayed at the top right corner of the screen.
d) Press “Exit” button when the adjustment finished. If this operation did not change any data,
the system would return to the blood cell analyzer window directly. Or else pops up the
“OK/Cancel” window. Press “OK” to save the adjustment result, while select “Cancel” to
cancel the adjustment result.
Caution:
Unnecessary and incorrect manual adjustment will cause unreliable analytical result. Make sure
the necessity of the operation.
Notice:
If the result of WBC is less than 0.5×103/uL, the system will not perform leukocyte differential
automatically.
36
Figure3-2
37
Chapter 4 Quality Control
CHAPTER 4 QUALITY CONTROL
Quality Control means the precision, accuracy and repeatability of the system. Quality control
provides reliable and effective methods for the possible system errors in detection and prevention.
The system errors may cause unreliable analytical result of the sample. To maintain the reliability
of the analytical results, periodic quality control of the instrument is required.
The instrument provides 9 QC files for user. It allows the operator to run quality control to the 12
parameters at the same time.
At first select a QC file, enter the assay and limit of control data. The system allows the operator
to run quality control with the 12 parameters or some of the 12 parameters simultaneously.
Warning:
NeoMedica recommends controls specially designed for the use of NCC-1211 instrument. To
unreliable results caused by using other controls, NeoMedica takes no responsibility.
Caution:
Controls must be stored in appropriate conditions.
Caution:
Do not use controls deteriorated or out of its expiration date.
Caution:
Be sure to finish the quality control in a certain time every day.
4.1 L-J QUALITY CONTROL EDIT
a) In the blood cell analyzer window, click <L-J QC> --<EDIT> button, The
instrument enters quality control edit window, as shown in figure 4-1.
38
Figure4-1
b) In quality control edit window, select the QC file you want.
c) Input Lot NO and Exp. Date of the control, the assay and limit of the quality
control parameters.
d) Press “Save” button to save the data of the current QC file.
e) Press “Del” button to delete the data of the current QC file.
f) Press “Back” button to save the data of the current QC file and return to the blood
cell analyzer window.
g) Press “Cancel” button to cancel all modification of the current QC file.
Notice:
If the parameter is an invalid data, the system will take the assay and limit as no assignment.
It needs to re-input. Or else the quality control will only act on other parameters.
Notice:
If the lot number or expiration date is invalid, the system will take them as no assignment. It
needs to re-input. Or else the QC file cannot run quality control program.
39
4.2 L-J ANALYSIS
Input QC parameters and perform QC run of the specified file.
a)In the blood cell analyzer window, click <L-J QC> --<Analysis> button, the instrument enters
quality control edit window, as shown in figure 4-2.
b) Prepare the controls and shake up the container until it well-mixed.
c) Place the controls under the sample needle. Press “START” key, the indicator lamp start to
glitter on the front panel of the instrument, the instrument imbibes the controls, move the
controls away until the indicator lamp stops glittering.
d) When the measurement finished, the result will be displayed on the column of the current
window. If alarm occurs in measurement, the current result may be incorrect. Press “Del”
button to delete the result and test again after the problem is solved.
e) Press “Exit” button, the instrument will return to the blood cell analyzer window.
Figure 4-2
Notice:
Each QC file can store up to 31 QC data.
40
4.3 L-J CHART VIEW
The graph provides a visual observation of the control data, allowing the operator to observe the
possible deviations, trends or shifts of the instrument performance.
In blood cell analyzer window, click<Function>--- <L-J QC> --<Chart> button. The instrument
enters quality control graph window, as shown in figure 4-3.
Figure4-3
The screen can display 4 QC figures at the same time. The figure shows the lot number, time,
number and distribution of the QC data. Click the scroll bar on the right of the screen. You can
continuously select the QC graphs of different parameters.
The X-axis of the graph represents running times of the quality control. The broken line above the
QC graph: assay +limit. The broken line below the QC graph: assay-limit.
The three parameters at the left side of the QC graphs from top to bottom:
assay + limit
assay
assay - limit
41
The three parameters at the right side of the QC graphs from top to bottom:
Mean: average value
Diff: standard deviation
CV: coefficient of variation
The vertical line in the middle of the QC graphs indicates the current chosen number. Click the
scroll bar on the left of the screen. You can continuously select the different number.
The chosen number is displayed in the data box below the corresponding parameter. The test time
for the chosen number is displayed in the time box on the screen.
In the QC graphs window, the following marks represent:
The mark “*” between the broken line represents that the point is within control range.
Otherwise it is out of control range.
The mark “.” represents that the parameter value is outside the orerating range, or error has
occurred during the run. Blank represents that there is no quality control on running.
Press “Print” button, it will print the data of the parameters on the screen.
Press “Return” button to return to the blood cell analyzer window.
4.4 L-J QUALITY CONTROL LIST VIEW
In blood cell analyzer window, click<Function>--- <L-J QC> --<List> button. The instrument
enters quality control graph window, as shown in figure 4-4.
42
Figure4-4
The screen can display the 12 QC parameters of 7 groups at the same time. Operate the scroll
bar in to select different serial number. Press “Print” button, it will print the data of the
parameters on the screen. Press “Return” button to return to the blood cell analyzer window.
43
Chapter 5 Calibration
CHAPTER 5 CALIBRATION
The instrument has been calibrated strictly at the factory. You may need to perform calibration
procedures when you replace any component that involves the primary measurement characteristics,
or when the shift occurs during controls. Calibration of the instrument is to provide the assurance that
the instrument is providing results with accuracy as design.
The purpose of calibration is to ensure the accuracy of the measurement result meet the requirement of
the design all the time.
To ensure the accuracy of the instrument and obtain reliable measurement results, it is necessary to
calibrate the instrument in the following situations:
a) Installation for the first time or re-setup in a new place.
b) The instrument is maintained.
c) The result of quality control is abnormal.
d) Replace reagent.
To ensure the instrument’s precision and obtain reliable measured results, the instrument should be
calibrated in these situations:
Warning:
Calibrators authorized by NeoMedica is recommended. Calibrators should be stored and used properly
according to the calibrator manual.
Warning:
Make sure the instrument is in a normal state before calibration.
Warning:
Avoid using the result of the measurement on medical test or clinical before the calibration is finished
accurately.
The commercial calibrator or neutral controls that NeoMedica authorized is recommended. Check the
instrument and reagents carefully before calibration. Make sure the instrument is in normal status,
and make sure the required sample mode of the measurement.
5.1 MANUAL CALIBRATION
44
5.1.1Background Test
Refer to Chapter 3 “Sample Analysis”/Section 3.3. Ensure that the background test meets the
requirement and no malfunction occurs.
5.1.2Check Repeatability
To ensure the calibration accurate, it is necessary to evaluate the repeatability measurement of the
instrument. Make sure the instrument is in normal status, then perform calibration program.
The procedures are as follows:
a) In blood cell analyzer window, Measure repeatedly with the calibration (no less than 3 times).
b) Record the data of WBC, RBC, HGB, MCV, and PLT. Calculate the CV value according to
the following formula. Only the result is in the limit of table 5-1 can perform calibration.
∑(X
i=1
i − X ) 2
n −1
CV = ×100%
X
X -- average value of test result
X i -- test result of the <i> times
n -- test times of the sample
Parameter Repeatability (CV %)
WBC ≤2.5%
RBC ≤2.0%
HGB ≤2.0%
MCV ≤1.0%
PLT ≤6.0%
Figure 5-1
5.1.3Calculate Calibration Factors
Calculate the new calibration factors according to the following formula:
45
5.1.4Modify the Calibration factors
a) In the blood cell analyzer window, click <Function>---<Calibration> tab, enters the calibration
window, as shown in figure 5-1.
b) Select the calibration data you need from the calibration data menu box.
c) Press “Print” button. The instrument will print the current calibration result.
d) Press “OK” button to save the current calibration result and return to the blood cell analyzer
window.
e) Press “Cancel” button. The instrument will cancel the current calibration result and return to
the blood cell analyzer window.
Notice:
The instrument allows the user to input the factors with the range between 70%~130%.
Notice:
The instrument allows the user to input the factors with the range between 70%~130%.
Figure 5-1
46
5.2 AUTO CALIBRATION
The procedures are as follows:

a) In the blood cell analyzer window, click <Function>---<Calibration>---<Auto> The
instrument enters the auto calibration window, as shown in figure 5-2.
b) Input the reference value of each calibration parameter.
c) Prepare the calibrators and shake up the container until it well-mixed.
d) Place the calibrators under the sample needle. Press “START” key, the indicator lamp start to
glitter on the front panel of the instrument. The instrument imbibes the calibrators. Move the
calibrators away until the indicator lamp stops glittering.
e) When the measurement finished, the result will be displayed on the column of the current
window. If alarm occurs in measurement, the current result may be incorrect.
f) Press “Del” button to delete the result and test again after the problem is solved.
g) Press “Return” button, the instrument will return to the blood cell analyzer window.
Notice:
Calibration can be performed 5 times at the most.
Notice:
The calibration result will be displayed after testing 3 times.
Notice:
If the parameter is an invalid data, the system will not perform calibration. It needs to re-input
valid data.
Notice:
The permissive range of the factors is between 70% and 130%. If the result exceeds the range,
the system will not be able to save it. Find out the reason and perform calibration again.
47
48
Chapter 6 setting
CHAPTER 6 SETTING
The instrument has accomplished all the settings at the factory. For customer’s convenience, most
of the system parameters can be setup by the operator so as to meet various requirements.
Notice:
The operations in this chapter will change the running state of the instrument. Please make
sure the necessity of the changing before operating.
6.1 USER SETTING
In the blood cell analyzer window, click <Function>---<Setting>---<User> The instrument
enters the user setting window, as shown in figure 6-1
Figure6-1
Click <New> to create a new user and assign user level
Click <Edit> to modify user information
Click <Delete> to delete selected user from the list
6.2 DEVICE SETTING
In the blood cell analyzer window, click <Function>---<Setting>---<Device> The instrument
49
Chapter 6 setting
enters the device setting window, user can change the setting for below
6.2.1 Reference range
In the blood cell analyzer window, click <Function>---<Setting>---<Device>---<Ref. range>
The instrument enters the Reference range setting window as Figure 6-2-1
The 8 group reference values are displayed at the left side of the screen. The dot in front of the
reference value represents that this is the current selected reference group. The limits of the
reference value are displayed on in the limits boxes on the screen.
Click the dot in front of the group to select the group required for setting.
Figure6-2-1
Click “Default” button, the instrument will select the default reference values to replace the
current reference values.
Click the adjustable bar of the limits box to adjust the upper and lower limit of the reference value.
Function of menu and shortcut keys:
Save: Save the reference values of the current group.
Print: Print the reference values of the current group.
Chapter 6 setting
Cancel: To cancel all inputted modification
Back: Quit from current window, and return to upper level blood cell analyzer window.
Notice:
The default reference value may not suitable for the local conditions. User can modify it
according to the local specific circumstances.
Caution:
The changing of the reference value will cause variation of abnormal prompt on hematology
target. Please make sure the necessity about the change you want to make.
6.2.2 Reference Unit
In the blood cell analyzer window, click <Function>---<Setting>---<Device>---<Ref. Unit>
The instrument enters the Reference range setting window as Figure 6-2-2
Figure 6-2-2
6.2.3 Lab info.
The department information can help user setup perfect sorting information in advance, and
51
Chapter 6 setting
quicken the input speed and management of the sample information. Especially the abbreviation
greatly improves the communication and standardization construction of laboratory digital
information.
In the blood cell analyzer window, Click “Function/Setting/ Lab info”, the instrument enters
department setting window. As shown in figure 6-2-3
Figure 6-2-3
Click to choose the info which you want to edit, input accordingly
6.2.4Doctor info
In the blood cell analyzer window, Click “Function/Setting/Device/ Doctor”, the instrument
enters department setting window. As shown in figure 6-2-4
Chapter 6 setting
Figure 6-2-4
Click <New> to create a new dept as Figure 6-2-5
Figure 6-2-5
Click <Edit> to modify a selected Department as Figure 6-2-6
53
Chapter 6 setting
Figure 6-2-6
Click <Delete> to deleted a selected as Figure 6-2-7
Figure 6-2-6
Click <View> to review doctor in your selected dept as Figure 6-2-8
Figure 6-2-8
Chapter 6 setting
Click <New> to create a new doctor in selected dept. as Figure 6-2-9
Figure 6-2-9
You can edit doctor info here as Figure 6-2-10
Figure 6-2-10
Click <Delete> to delete selected Info as Figure 6-2-11
Figure 6-2-11
Click <Back to Dept> to return to operation in dept level
Click <Back> return to upper level
55
Chapter 6 setting
6.2.5 Alarm limit
In the blood cell analyzer window, Click “Funct/Setting/Device/ Alarm”, user can check the
alarm limit setting. As shown in figure 6-2-5
Figure 6-2-5
6.3 GENERAL SETTING
In the blood cell analyzer window, Click “Funct/Setting/General”, user can access below
function general setting.
6.3.1 Print setting
In the blood cell analyzer window, Click “Funct/Setting/General/Print” the instrument enters
print setting window. As shown in figure 6-3-1
Click Drop-down list to select
Selected printer：
Chapter 6 setting
Select Recorder, the data will only be transported to the recorder.
Select Printer, the data will only be transported to USB printer.
Template：
Select the template for print
Paper size: Set paper size here
Report style: Select report style for print
Parameter language: Parameter display language
Report title: Input report title here
Print copies: ? copies for print
Figure 6-3-1
Tick to select other below option for print
Print edit result
Print Limitation mark
Print Histogram mark
Print QC date
Auto-print after analysis
Auto-print after aduited
57
Chapter 6 setting
Note：
Printer model must be the same model as assigned, otherwise may lead abnormal print
6.3.2 Communication setting
In the blood cell analyzer window, Click “Func/Setting/General/COM set” the instrument
enters communication setting window. As shown in figure 6-3-2
Figure6-3-2
Click to select the setting you want to change and input value accordingly
Click <Ok> button to save your input
Click <Cancel> to cancel
6.3.3 Language setting
In the blood cell analyzer window, Click “Func/Setting/General/Lang. set” the instrument
enters Language setting window. As shown in figure 6-3-3
Chapter 6 setting
Figure 6-3-3
Click to select the language setting for analyzer
6.3.4 Scene setting
In the blood cell analyzer window, Click “Func/Setting/General/Scene set” the instrument
enters Scene setting window. As shown in figure 6-3-4
59
Chapter 6 setting
figure 6-3-4
Click to select the Scene setting for analyzer
6.3.5Screen saver setting
In the blood cell analyzer window, Click “Func/Setting/General/Screen saver” the instrument
enters Screen saver setting window. As shown in figure 6-3-5
Chapter 6 setting
Figure6-3-5
Click to select time interval setting for analyzer
6.3.6 Date and time setting
In the blood cell analyzer window, Click “Func/Setting/General/Date & Time” the instrument
enters Date and time setting window. As shown in figure 6-3-6
61
Chapter 6 setting
Figure 6-3-6
Click to select the Date format
Click button or to set the date/time as you want

Click <OK> button to save setting
Click <Cancel> to cancel your input, return to upper level
6.4 SYSTEM SETTING
In the blood cell analyzer window, Click “Func/Setting/System”， the instrument enters
System setting window. User can access below functions here:
6.4.1 Auto clean
In the blood cell analyzer window, Click “Func/Setting/System/Auto clean” the instrument
enters Date and time setting window. As shown in figure 6-4-1
Chapter 6 setting
Figure6-4-1
Click to select the Auto-clean time interval setting for analyzer
6.4.2 Auto maintenance setting
In the blood cell analyzer window, Click “Func/Setting/System/Auto clean” the instrument
enters Auto maintenance setting window. As shown in figure 6-4-2
63
Chapter 6 setting
Figure 6-4-2
Click to select the Auto-maintenance time interval setting for analyzer
6.5 RESTORE FACTORY SETTING
In the blood cell analyzer window, Click “Func/Setting/Restore” the instrument enters
Restore factory setting window. As shown in figure 6-5
Chapter 6 setting
Figure6-5
6.6 SHUTDOWN
Shutdown routine must be performed before turning off the power everyday.
During shutdown procedure, the instrument will perform daily maintenance and clean the tubing
automatically.
Click the <Func.>---<Shutdown>, procedures are as Figure 6-6
65
Chapter 6 setting
Figure6-6
Put cleaner directly under sampling needle, press <Start> Key, as Figure 6-6-1：
User need to follow with shutdown process after daily operation. Analyzer will perform daily
maintenance for tubing system during shutdown process. As Figure 6-6
Chapter 6 setting
Figure6-6-1
Analyzer begins to clean as Figure 6-6-2
67
Chapter 6 setting
Figure6-6-2
Wait for cleaning to proceed, when it finished, analyzer will enter below window. Then, user
can cut off the power supply of analyzer as Figure 6-6-3
Figure6-6-3
a) In the blood cell analyzer window,Select “Shutdown” in the menu, pops up shutdown
window, as shown in Figure 3-3.
b) If you do not want to shutdown the instrument for the moment, click “Cancel” to return to
the blood cell analyzer window.
c) Press “OK”, the instrument will perform daily maintenance and clean the measuring tubing.
When the shutdown procedure finished, the screen displays “Turn off the power now”,
turn off the power on the rear panel of the instrument.
d) Turn off the printer power (if equipped), clean the workbench and dispose the waste.
Notice:
Do not turn off the power of instrument directly while performing the shutdown procedure.
Chapter 7 Review
CHAPTER 7 REVIEW
The instrument can automatically store the results after each sample analysis. The operator can
review, search, modify, print, and delete the data.
7.1 SAMPLE REVIEW
In the blood cell analyzer window, Select “Function/Review” button. As shown in figure 7-1.
Figure7-1
The data can be reviewed and printed in table.
8 sample parameters are displayed in each review screen in the order of time sequence.
The button of scroll bars at the bottom of the screen shows the current position.
The meaning of the characters as follows:
“↑” is displayed following the parameter indicating that the results exceed the high limit of
the system.
“↓” is displayed following the parameter indicating that the results exceed the low limit of the
69
Chapter 7 Review
system.
“C” is displayed following the parameter indicating that clogs occur during the test.
“B” is displayed following the parameter indicating that bubbles occur during the test.
Review the sample data
Click the left button at the bottom of the screen to review the rear data.
Click the right button at the bottom of the screen to review the front data.
Click the button at the bottom of the screen to review the data of the next page.
Click the button at the bottom of the screen to review the data of the previous
page.
Click the button at the bottom of the screen to review the data of last page.
Click the button at the bottom of the screen to review the data of first page.
Delete the selected data The procedures as follows:
a) Click “NO” button at the top of the screen, the data will be selected. Click again, the
selection will be canceled.
b) Select “Delete” in the menu, pops up a dialog box, let user choose to delete the data
or not. Press “OK” button, the data will be deleted. Press “Cancel” button, the
operation will be cancelled.
Delete all data
a) Press <Batch> button. Then click “Select All” button, the data will be selected. Click
<Unselect>, the selection will be canceled.
b) Click “Delete” button, pops up a dialog box, let user choose to delete the data or not.
Press “OK” button, the data will deleted. Press “Cancel” button, the operation will be
cancelled.
Print the selected sample data in table
a) Click “NO” button at the top of the screen, the data will be selected. Click again, the
selection will be canceled.
b) Click “Print” shortcut key, the selected data would be printed in table.
Search sample data
a) Click <Find> button, pop up the search window, as shown in figure 7-2.
Chapter 7 Review
b) Click the box of the item in need to search. input the key word you want to search.
c) Repeat the b) procedure until the current inputting item finished. Click “Cancel”
button to cancel the searching. Click “OK” button, start to search the data. When
the searching finished, the proper sample data will be displayed on the screen.
Figure7-1-1
Find： Find record in a certain range by input start and end as Figure 7-1-2
Figure7-1-2
71
Chapter 7 Review
Detail：Review record in detail window
Find：Find record of input condition
Delte：Delete selected record
Print: Click to select record, then click button <Print> at right-upper corner as Figure 7-1-3:
Figure7-1-3
Back: Quit current window, return to upper level
7.2 DETAIL REVIEW
In review window, click “Detail” button. The instrument will access the detail review window, as
shown in figure 7-3.
This window can review, modify, and print the sample data in graphs.
Review
Click “Next” button to review the next data.
Click “Previous” key to review the previous data.
Modify Sample Information
Click “Edit Info” button, pops up “Information” window. The operation of this window
Chapter 7 Review
refers to Chapter 3 “Sample Analysis”/ Section 3.6.1.
Modify Sample Data
Click Histogram” button, The operation procedures as follows:
a) Click “Para” shortcut key, you can select WBC, RBC and PLT in turn.
b) Click “Line” shortcut key, you can select the sorting lines in the histogram.
c) Click “Right” or “Left” shortcut key, you can move the sorting line to right or left. The
data calculated according to the new sorting line would be displayed in the data area at the left
side of the screen.
d) Click “Exit” shortcut key. If user has modified the sample data, there will a dialog box
pops up. User can select save the modification result or not. Click “OK” button, the result will be
saved, Click “Cancel” button, the result would not be saved and the system exit from histogram
modification status.
Figure7-2
a) Click button <Histogram> , user can select WBC，RBC，PLT histogram
b) Click <Next> <Previous> button to select terminus in Histogram
c) Click <Left>, <Right> button, move left/right for the terminus. The data calculated
73
Chapter 7 Review
according to the new sorting line would be displayed in the data area at the left side
of the screen.
d) Click <Back> button, If user has modified the sample data, there will a dialog box
pops up. User can select save the modification result or not. Click “OK” button, the result
will be saved, Click “Cancel” button, the result would not be saved and the system exit
from histogram modification status.
The functions of the button as follows:
Previous: Review the previous data.
Next: Review the next data.
Information: Input and modify the sample data.
Print: Print the current sample data.
Back: Exit from the current window and return to blood cell analyzer window.
74
Chapter 8 Service
CHAPTER 8 SERVICE
This chapter gives the description of various service functions provided by the instrument. These
functions will bring user convenient and pleasure.
In the blood cell analyzer window, press the right key of the mouse, pops up the menu. Select
“Function/Service”. As Figure 8-1
Figure8-1
8.1UNIT INFORMATION
In the blood cell analyzer window, Select <Function>---<Service>---<Unit info>,
enter unit information window to check Unit information
8.2 UPGRADE
In the blood cell analyzer window, Select <Function>---<Service>---<Upgrade>,
enter unit upgrade window as Figure 8-2
75
Chapter 8 Service
Figure8-2
Unit can be upgraded with USB flash disk
1.Select USB disk, insert USB to analyzer USB port, wait 5s
2. Click <Upgrade button>，analyzer will begin to upgrade
3. When upgrade finished, remove the USB flash disk, back to analyzer window, run the
Shutdown procedure.
4. Analyzer will reboot after upgrade
Click button <Cancel> to return to upper level
8.3 LOG
In the blood cell analyzer window, Select <Function>---<Service>---<Log>,
User can review the running log of analyzer
8.4 ENGINEERING
Chapter 8 Service
Figure8-4
8.4.1 Normal Clog clean
This function is used for solving general probe clogs.
The instrument makes a fixed pressure and voltage act on the probe to get rid of the clogs.
77
Chapter 8 Service
Figure8-4-1
8.4.2 Enhanced clog clean
This function is use to solve indolent probe clogs. As Figure 8-4-2
Strong cleaner would be injected into WBC and RBC count pool. Get rid of the indolent probe
clog by soaking it in the strong cleaner. Before performing the function, user should prepare the
strong cleaner well.
Chapter 8 Service
Figure8-4-2
Adding strong cleaner as figure8-4-2-1:
Figure8-4-2-1
79
Chapter 8 Service
Wait 600S for analyzer to proceed, as figure 8-4-2-2:
Figure8-4-2-2
Figure8-4-2-3
Chapter 8 Service
8.4.3 Cleaning
This function is used for the routine cleaning of the probe, sample needle, measurement tubing.
As Figure 8-4-3:
Figure8-4-3
8.4.4ENHANCED CLEANING
This function is used for the enhanced cleaning of the probe, sample needle, measurement tubing.
8.4.5 DRAIN CHAMBERS
Drain chambers As figure 8-4-5:
81
Chapter 8 Service
Figure8-4-5
Click <OK> to prime in chamber as Figure 8-4-5-1:
User can use this function to observe chamber status
Figure8-4-5-1
Chapter 8 Service
8.4.6 Parking
If the instrument is not going to be used in 2 week or longer, use this function to clean and empty
the instrument. It is convenient for user to store the instrument. Prepare distilled water before
performing the function.
8.4.7 Prime diluent
Prime diluent to relative tubing as Figure 8-4-7:
Figure8-4-7
8.4.8 Prime Lyse
83
Chapter 8 Service
Figure8-4-8
8.4.9 Prime cleaner
Figure8-4-9
Chapter 8 Service
8.4.10 Maintenance
User can finish the weekly maintenance according to the prompt information on the screen.
Prepare cleaner and strong cleaner before performing the function.
8.5 SELF-DETECTION
Click button <Test> enter self-detection window. User can complete the detection of the valve,
motor, circuit and interface. It is helpful to the insurance of the malfunction.
Valve:
“ON” represents the valve is on.
“OFF” represents the valve is off.
As Figure 8-5-1:
Figure8-5-1
Circuit：
“OK” represents the circuit is in normal status.
“FAIL” represents the circuit is failure.
85
Chapter 8 Service
“OFF” represents no negative pressure.
“ON” represents there is negative pressure.
“LOW” represents the temperature is below 15℃.
As Figure 8-5-2:
Figure8-5-2
Motor and interface
Motor
“OK” represents that the motor is in normal status.
“FAIL” represents the motor is failure.
As Figure 8-5-3:
Chapter 8 Service
Figure8-5-3
8.6 HELP
In the blood cell analyzer window, click <Func.>---<Service>---<Help> , the help windows will
pop up. As shown in figure 8-6:
89
Chapter 8 Service
Figure8-6
Click button ，line down
Click button ，line up
Click button , move to last page
Click button ，move to first page
Chapter 9 Maintenance
CHAPTER 9 MAINTENANCE
As other precision instrument, only careful daily service and periodic maintenance can the
instrument have a good working status, and can we get the reliable measurement results and have
few malfunctions. This chapter introduces some preventive methods for service and maintenance.
If you want to know more relative information, please contact the customer service department of
NeoMedica.
According to the requirements for maintenance of the instrument during the using procedures, we
divide the preventive service and maintenance into the following types: daily, weekly, monthly,
yearly and maintenance according to actual need.
Warning:
It is important for the hospital or organization that employs this instrument to carry out a
reasonable maintenance schedule. Neglect of this may result in machine breakdown.
9.1 ROUTINE MAINTENANCE
9.1.1 Clean the Appearance
Wipe the appearance of the instrument with neutral detergent or distilled water.
Caution:
Avoid using corrosive acids, alkali, and volatile organic solvent such as: acetone, aether,
chloroforms to wipe the appearance of instrument. Only neutral detergent can be used.
Caution:
Avoid wiping the inner of the instrument.
Replace Fuse
The fuse is installed in the fuse-box on the side of power switch. Open the box to replace the fuse
expediently.
Appointed specification fuse: AC T3.15AL 250V
Warning:
89
Only appointed specification fuse can be used.
9.2 DAILY MAINTENANCE
It can be divided into two types: run and shutdown.
Run
The instrument has installed daily maintenance procedure. On running, it can execute
auto cleaning procedure according to the quantity of the sample to keep the instrument
in good working status. Set the auto cleaning procedure according to the section 6.3. The
general setting principles are:
Working time > 8 hours, auto-cleaning time=8 hours;
4 hours<Working time<8 hours, auto-cleaning time=4 hours;
Working time< 4 hours, auto-cleaning time=2 hours
The auto-cleaning time will decrease 1 hour year by year.
Shutdown
When the instrument is shutdown, it will run daily shutdown auto cleaning procedure.
You only need to clean the workbench and wipe the appearance of instrument when the
power-off.
9.3 WEEKLY MAINTENANCE
This instrument has installed weekly maintenance procedure. Act as follows:
a) Prepare concentrated cleaner and strong cleaner.
b) In the main operation window, press the right key of the mouse, pops up the menu. In the
menu area, select “Service/Maintenance”. Operate as the screen shows.
c) Turn off the power supply.
d) Wipe the appearance of instrument as section 9.1.1.
9.4 MONTHLY MAINTENANCE
It is necessary to clean the dust of the instrument monthly.
Operate as follows:
a) Turn off the power supply, and pull out the power line.
b) Hold up the air filter cover with slotted screwdriver.
c) Take off the cover and the net. Clean them with neutral detergent brush and put them
in the shade. Airing naturally .Brush away the dust clinging on the air filter grid at the
rear panel of instrument.
d) Put the air filter grid on the air filter net carefully. Planish them.
Notice:
Only can use the neutral detergent cleaning the air filter. Avoid airing it with heat.
9.5 YEARLY MAINTENANCE
It’s necessary to perform preventive maintenance once every year. Because of the
highly-requirements for yearly maintenance, the maintenance should be performed by the
authorized engineer of NeoMedica. Please contact the customer service department of NeoMedica
before yearly maintenance.
9.6 MAINTENANCE BEFORE TRANSPORT OR FOR THE INSTRUMENT THAT
WILL NOT BE USED FOR A LONG TIME
If the instrument is not going to be used in 2 weeks or longer, or need to pack and transport,
performing the following procedures:
a) In the main operation window, press the right key of the mouse, choose “Service/Park” in
the menu.
b) Operate as screen shows.
c) Rotate the bottle covers of rest reagents and store them as the reagent operation
introduction. User should perform efficient action to prevent the material from deteriorating,
mis-eating and misusing.
d) Plug the stopples which were pulled out at the first installation into the corresponding tube
connector.
e) Pull out diluent connection tube, cleaner connection tube, lyse connection tube and waste
connection tube and clean them with distilled water. Dry them in shady place, then
packing them into plastics.
f) Pull out the power wire, packing it in plastics after cleaning with neutral detergent.
91
g) Put the instrument and parts packed in plastics into packing cases.
92
CHAPTER 10 TROUBLESHOOTING
This chapter contains information that is helpful in identifying and resolving instrument problems
that may occur in the operation of the analyzer. If the problems cannot be corrected with the aid of
this chapter, the user should contact the Customer Service Department of NeoMedica.
10.1 ABNORMAL STARTUP

Methods and procedures:
a) Check if the power is on.
b) Check if the power socket is loose.
c) Check if the fuse is broken. If broken, replace it as section 9.1.2.
10.2 WASTE FULL

Dispose of the waste in waste container.
10.3 DILUENT EMPTY

a) Replace diluent.
b) In the blood cell analyzer window, press the right key of the mouse, pops up the menu.
Select “Function/Service/Prime Diluent” in the menu.
10.4 LYSE EMPTY

a) Replace lyse.
Select “Function/Service/Prime Lyse” in the menu.
10.5 CLEANER EMPTY

a) Replace cleaner.
Select “Function/Service/Prime Cleaner” in the menu.
10.6 WBC CLOG OR RBC CLOG
If the count time exceeds high limit of the setting during measurement, there will “Clog” alarm
occurs.
93
a) In the blood cell analyzer window, press “Flush” shortcut key.
b) If the upper method could not solve the problem, perform as the following procedures.
c) In the blood cell analyzer window, press the right key of the mouse, pops up the menu.
Select “Function/ Service/ Enhanced Flush” in the menu. Follow the screen prompt
information to finish it.
10.7 WBC BUBBLES OR RBC BUBBLES

If the count time exceeds low limit of the setting during measurement, there will be “Bubble”
alarm occurs.
In the blood cell analyzer window, press right key of the mouse, pops up the menu. Select
“Function/ Service/ Enhanced Flush” in the menu.
10.8 HGB ERROR

a) In the blood cell analyzer window, press the right key of the mouse, pops up the menu.
Select “Function/ Service/Cleaning”.
Select “Function/ Service/ Enhanced Cleaning” in the menu.
10.9 HGB BUBBLES

a) In the blood cell analyzer window, press the right key of the mouse, pops up the menu.
Select “Function/ Service/Cleaning”.
Select “Function/ Service/ Enhanced Cleaning” in the menu.
10.10 RECORDER OUT OF PAPER

a) Gently press the recorder door to open it.
b) Insert the new paper into the paper entry, and make the printing side towards the thermal
head.
c) When the paper juts out from the other side, pull it out and keep it straight.
d) Pull the paper out of the paper exit.
e) Close the door of the recorder.
10.11 RECORDER TOO HOT
Possible reasons:
The thermal head of the recorder is too hot.
Suspend using the recorder for 5 minutes.
10.12 THE RESULT OF BACKGROUNG TEST TOO HIGH

a) In the blood cell analyzer windows, press right key of the mouse, pops up the menu. Select
“Function/ Service/Cleaning”.
b) If the upper method could not solve the problem, repeat the procedure 3 times. If the
problem still can not be solved, perform as the following procedures.
c) In the blood cell analyzer windows, press right key of the mouse, pops up the menu. Select
“Function/ Service/ Enhanced Cleaning”.
d) If the upper method could not solve the problem, repeat the procedure 3 times. If the
problem still can not be solved, perform the upper procedure after replacing all the
reagents.
95
ANNEX 1: SYMBOL
Annex 2: Toxic and harmful substances or elements name and content.
ANNEX 2: TOXIC MATTER OR ELEMENTS NAME AND CONTENT
Toxin matter or elements

Component
(Pb) (Hg) (Cd) (Cr(VI)) (PBB) (PBDE)
(1)
Front panelPCBA × 〇〇〇〇〇
Front panel LCD assembly 〇〇〇〇〇〇
assembly Plastic casing 〇〇〇〇〇〇
(2)
Sheet metal 〇〇〇 × 〇〇
(1)
PCBA × 〇〇〇〇〇
(2)
Sheet metal 〇〇〇 × 〇〇
Machine parts 〇〇〇〇〇〇
Main body Plastic 〇〇〇〇〇〇
Ceramic 〇〇〇〇〇〇
Metal parts 〇〇〇〇〇〇
Cables 〇〇〇〇〇〇
Tube 〇〇〇〇〇〇
Label 〇〇〇〇〇〇
Bottle cap 〇〇〇〇〇〇
Accessory Tools 〇〇〇〇〇〇
swap 〇〇〇〇〇〇
Other tools 〇〇〇〇〇〇
Packing Packing material 〇〇〇〇〇〇
〇: Mean all Toxin matter or elements content in component is comply to SJ/T 11363-2006
×: Mean at least one Toxin matter or elements content in component is exceed SJ/T 11363-2006。
(1) Some components on PCBA content Pb, during soldering process
(2) Some sheet metal may use (Cr(VI)) at plate coating
97
Annex 3: Supported external printer
ANNEXT 3: SUPPORTED EXTERNAL PRINTER
1. Support model list:

1） HP 1020P laser printer
98
-2310
I.
1.
2. LCD.
3.
4. START.
1. Đ
2. RS232.
3. RJ45.
4. USB.
5. VGA.
6.
7.
8.
9. CLEANER.
10. DILUENT.
11. LYSE.
12.
13. Đ
14.
II.
A.
1.
2.
Pre-diluent
venous capilliary
L-J QC QC.
Detail.
%CV.
QC.
QC
Xem L-J QC
Xem L-J QC
Lyse.
CLEANER.
PCBA, van,
: Xem file
: Ch
B.
1.


 Đ
2.
 Diluent
 xanh
 Đ
3.


 Đ
4.

 Waste
 B
 Đ
C.





III.
A.
1. backrgound
background
 info Textbox, thay

ID OK
 START background
Diluent background
 Sample Mode
PreDiluted.
 ng trên Diluent
 Đ START Diluent
Start Deluent
background
 Exit
2.
WBC ≤0.2 109/L

RBC ≤0.02 1012/L
HGB ≤1 g/L
HCT ≤0.5 %
PLT ≤10 109/L
IV.
A.
1.
 Info
textbox OK
Cancer
 Sex male female)
 Name:
 Age

 Bed NO
 ID -9999.
 Sent Time
 Samping Time
B.
 Đ Start cup
 Auto).
C.
 “ ”
 “ ”
 “ ”
 “ ”
 “ ”
PHOENIX NCC-3300
Máy phân tích huy t h c t đ ng
Hư ng d n s d ng
V15.05 vn
1. M t trư c
3 2
Hình 1 M t trư c
1. Kim hút m u
Hút b nh ph m
2. RUN Key (Phím nh n ch y)
Nh n phím này đ ch y máy, ch y startup, b nh ph m, QC Phím ch có tác
d ng khi trên màn hình là ch y m u, startup, QC.
3. Recorder (Máy in)
In k t qu ch y
4. Touch Screen (Màn hình c m ng)

Màn hình LCD 10.4 inch. Màn hình chia làm 5 khu v c như hình 1-2.
Hình 2 Màn hình
• Prompt Information (Ph n thông tin)

Hi n th thông tin tr ng thái máy đang làm vi c.
• Mode
Hi n th Mode đang th c hi : Máu toàn ph n, Máu có pha loãng.
• System Time (Đ ng h máy)
Hi n th ngày tháng năm và đ ng h
• Test Result (k t qu ch y m u)
Hi n th k t qu ch y m u.
• Menu
Hi n th các ch c năng c a Menu và chia làm 2 lo i.
Menu đ u tiên đư c hi n th phía dư i c a màn hình như hình
1-3.
Hình 3 Màn hình chính
Func: Vào menu ph .

Info: M màn hình nh p thông tin b nh ph m ti p theo.
Rev: Truy c p vào d li u b nh ph m trư c đó.
Histo: Vào màn hình đ th b nh ph m.
Drain: Nh ch t pha loãng ra đ u kim thư ng s d ng trong trư ng pha loãng
Trans: Truy n k t qu lên m ng.

Print: In k t qu ra máy in.
Mute: T t âm thanh báo đ ng.
Help: M c a s tr giúp.
Exit: Nh n đ th c hi n chu trình t t máy.
Menu th c p như hinh 1-4:
Hinh 4 Ch c năng c a Menu

Back: Tr l i Menu trư c.
Maint.: Tr v màn hình chính
Limit: Vào màn hình cài đ t thông s gi i h n.

Stast.: Tính toán kh i lư ng công vi c và th i gian
QC: Vào màn hình ch y QC.
Cal.: Vào màn hình ch y Calib.
Setup: Vào màn hình cài đ t thông s .
Sev.: Vào màn hình Service, ki m tra, b o trì.
Help: Vào màn hình tr giúp.
1.1.4 M t sau máy
Hình 5 Phía sau máy

1.COMI and COM2
Chu n k t n i RS232.
2. PRINTER
N i v i máy in ngoài
3.USB Port
C ng n i thi t b USB
4. PS2 port
C ng n i bàn phím, chu t
5. Grounding Terminal
Đi m n i ti p đ t cho máy.
6.Fan
Qu t làm mát ngu n cho máy.
7.Power Receptacle
N i ngu n đi n cho máy
8.Power Switch
Công t c b t.T t máy
9.SENSOR
N i c m bi t bình nư c h i
10. DETERGENT
N i ng nư c r a.
11. WASTE
N i ng nư c th i
12. LYSE
N i ng hóa ch t Lyse.
13. DILUENT
N i ng Diluent.
1.2 Các thông s

Máy t đ ng phân tích thành ph n b nh ph m v i 3 thành ph n b ch c u, Hi n th 21
thông s , 3 bi u đò WBC, RBC and PLT. Tham kh o b ng 1-1 đ th y 21 thông s
Table 1-1 21 thông s
Abbreviation Full Name Unit
WBC White Blood Cell Count 109cells/L
LYM% Lymphocyte Percent %
MID% Monocyte Percent %
GRAN% Granulocyte Percent %
LYM# Lymphocyte Count 109cells/L
MID# Monocyte Count 109cells/L
GRAN# Granulocyte Count 109cells/L
RBC Red Blood Cell Count 1012cells/L
HGB Hemoglobin Concentration g/L
HCT Hematocrit (relative volume of erythrocytes) %
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
MCHC Mean Corpuscular Hemoglobin Concentration g/L
RDW_CV Red Blood Cell Distribution Width repeat %

precision
RDW_SD Red Blood Cell Distribution Width STDEV fL
PLT Platelet Count 109cells/L
MPV Mean Platelet Volume fL
PDW Platelet Distribution Width fL

Figure 3-1 Main menu Screen
3.9 Ch y Background
Ch y ki m tra Background nên đư c th c hi n trư c khi ch y m u b nh ph m, cách th c hi n:
1) Đ t m t ng s ch không có gì bên dư i kim hút. Tai màn hình menu chính nh n vào Mode
phía trên mà hình, Mode hi n t i s chuy n qua “Pre-diluent” mode, sau đó nh n “Drain đ
đư c đưa hóa ch t Diluents vào ng m u.
2) T i màn hình Menu chính nh n “Info”, và đ i ID thành 0, nh n “OK” đ lưu và quay l i.
3) Nh n “Pre-diluent” đ chuy n qua “Whole Blood” mode, Đưa ng có ch a ch t

Diluents vào đ u kim hút sao cho đ u kim ch m t i đáy c a ng m u.
4) Nh n phím RUN phía trư c máy, b ng m u sau khi nghe ti ng Bíp. Sau đó máy s
t đ ng đ m và đo đ c.
5) Th i gian đ m RBC, WBC s đư c hi n th góc phía dư i bên ph i màn hình trong th i

gian đ m. H th ng máy s báo đ ng và thông báo l i phía trên bên trái màn hình n u
như th i gian đ m là quá lâu ho c quá nhanh.
6) B ng giá tr ch p nh n đư c th hi n như b ng 3-2.

Table 3-2 Acceptable Range of Background
N u m t trong các giá tr vư t quá giá tr bên trên thì c n ph i th c hi n l i Back-

ground Test
CHÚ Ý: S ID c a background test là set v 0 b i ph n m m s không t o file k t qu và
cũng không lưu tr trong b nh .
NOTE: S ID c a m u không bao gi đư c đ t v i giá tr 0.
3.10 Quality Control (Ch y QC)
Ch y Qc nên đư c th c hi n đ u m i ngày trư c sau khi kh i đ ng máy và trư c khi

ch y b nh nhân
3.11 Calibration (Ch y hi u chu n)
Lúc cài đ t ban đ u n u như k t qu background và k t qu QC là bình thư ng thì

không c n thi t ph i ch y hi u chu n. n u không ho c các thông s có giá tr d ch
chuy n ho c sai thì c n ph i ch y l i hi u chu n.
3.12 Collection of Blood Sample (l y m u b nh ph m)
C NH BÁO: T t c các m u b nh ph m, m u QC, m u Calib đ u có ch a thành ph n

máu ngư i nên c n thi t ph i m c áo b o h , găng tay, kính b o h theo như quy đ nh
khi mà ti p xúc v i các m u b nh ph m.
C NH BÁO: L y máu và x lý máu c n ph i tuân th theo các quy đ nh v môi trư ng đ a
phương, qu c gia, và theo các quy đ nh c a phòng thí nghi m
C NH BÁO: Ch c ch n r ng m u b nh p m đư c đ ng trong ng s ch cáo ch ng
đông. T t c các b n ph m bình thư ng đư c l y trong các ng có ch a ch t ch ng
đông EDTA (EDTA-K2'2H20) là ch t đư c s d ng trong các phòng thí nghi m.
C NH BÁO: Không đư c l c m nh các ng m u.

NOTE: Các m u máu còn có th đ đư c 4 gi trong nhi t đ phòng. Theo khuy n cáo c a
chúng tôi thì nên gi các m u nhi t đ t 2 - 8 đ đ có th đ đư c lâu hơn.
3.12.1 Venous Blood Collection (L y máu tĩnh m ch)
L y máu tĩnh m ch c n l y vào ng s ch có ch a ch t ch ng đông EDTA-K2·2H20, đ

có th gi đư c các WBC, RBC và tránh k t t p ti u c u, L c ng m u t 5~10 l n đ
tr n đ m u.
3.12.2 Peripheral Blood Collection (l y máu ngo i vi)
L y máu ngo i vi có th đư c l y các đ u gón tay, th tích máu có th l y đ n 20µL.

C NG BÁO: Không b o gi đư c n m nh đ u ngón tay khi l y đ tránh các d ch ph n
m m vào trong ng, D ch này có th làm sai k t qu đo đ c.
3.13 Mode Switch (Chuy n Mode)
Trên hình 3-1 th hi n phím chuy n các mode đo đ c khác nhau theo mong mu n Whole
Blood Mode for Venous Blood, Pre-diluent Mode for Peripheral Blood and Whole Blood
Mode for Peripheral Blood. Các thông s s hi n th theo t mode đư c ch n..
3.14 Sample Counting and Analysis (Đ m và phân tích)
Đ m và phân tích m u đư c th c hi n theo trình t sau.
3.14.1 Information Input (Nh p thông tin)
Thông tin nh p theo cách b ng tay
Nh n "info" trên màn hình Menu chính, Màn hình nh p thông tin xu t hi n (như hình 3-2),
iNh p h c ch n dũ li u r i nh n "OK" đ lưu thông tin và đ quay l i mà hình menu
chínhnh n "Cancel"
Nh n Cancel đ tr v màn hình Menu chính
Figure 3-2 Info Edit Window
Name: Nh p tên b ng các ch cái.

Sex: Ch n gi i tính, đ m c đ nh là đ tr ng.
Age: Nh p ngày tháng năm snh
Blood : Ch n nhóm máu A, B, 0, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-. 0
Rh+, 0, Rh-. N u không thì đ tr ng.
Limit: Ch n l o gi i h n Auto, Man, Woman, Child, Infant~ Neonate, General, User 1, User
2, User 3. n u không ch n s là b ng giá tr như b ng 3-3.
Reference value Age Sex
General No input Blank, M, F
General ≥16- year Blank
Man ≥16- year M
Woman ≥16- year F
Child ≥1- year and <16- year Blank, M,F
Infant ≥1- year and <16- year Blank, M,F
Neonate <1-month Blank, M,F

ID: S ID b nh ph m n p t 00000000-99999999. N u không nhâp ID thì ID chính là
s hi n t i. S ID đư c t đ ng tăng lên 1 s so v i s trư c đó.
Sample No.: Nh p s c a b nh ph m.
Bed No.: Nh p s giư ng b nh nhân.
Sender: Nh p tên ngư i g i m u.
Dept.: Nh p khoa phòng hc ngư i ph trách g i m u
Checker: Nh p tên c a ngư i ki m tra.
Assessor: Nh p tên c a ngư i th c hi n
GHI CHÚ: S ID đ t là 0 ch dành cho ch background test. ID b nh ph m không đư c

đ t là 0
3.14.2 Counting and Analysis (Đ m và phân tích)
Vi c đ m và phân tích đư c th c hi n t 3 đ n 5 phút cho m t b nh ph m

Mode Pre-diluent (pha loãng) cho Peripheral Blood (máu ngo i vi)
1) Đ t m t ng không có gì dư i đ u kim hút m u, nh n "Drain"; đ l y 1 lư ng diluent vào trong

ng.
2) Cho 20uL c a máu ngo i vi vào trong ng đó, và l c đ tr n đ u m u và pha loãng.
3) Đ t ng đã pha phía bên dư i kim m u và đ m b o r ng kim m u ch m nh vào đáy
ng b nh ph m.
4) Nh n phím RUN đ hút m u và nh c ng ra su khi nghe ti ng Bíp.
5) Quá trình s đư c th c hi n trong t i gian, đ ngh ch
Mode Whole Blood (toàn ph n) cho Venous Blood (máu tĩnh m ch)
1) Đ t ng m u máu phía bên dư i kim m u và đ m b o r ng kim m u ch m nh vào đáy

ng b nh ph m.

Mode Wole Blood (máu toàn ph n) cho Peripheral Blood (máu ngo i vi)
1) L c đ u ng m u máu và đ t phía dư i kim hút m u đ kim m u có th

hút đư c,
K t qu và đ th c a WBC, RBC and PLT s đư c hi n th trên màn hình sau khi đã đư c

đ m và phân tích (xem hình 3-1).
N u đ Auto Rec ho c Auto Print là ON (cài đ t trong "system setting"), k t qu s t
đ ng đư c in ra.
N u như v n đ v t c, b t khí, xu t hi trong quá trình đo đ c thì h th ng s báo đ ng và
hi n th thông tin góc trên bên trái màn hình. K t qu đó không đư c ch p nh n
3.14.3 Special Function (ch c năng đ c bi t
Có 2 ki u c a báo đ ng: Báo đ ng các thông s và báo đ ng v bi u đ
3.14.3.1 Parameter Alarm (Báo đ ng thông s )
"H" ho c "L" xu t hi n phía bên trái c a thông s cho th y giá tr đó cao ho c

th p hơn d i bình thư ng tham kh o.
"***" V i d u hi u này thì k t qu đó không đư c ch p nh n và không hi n th .
3.14.3.2 Histogram Alarm (Báo đ ng bi u đ )
N u bi u đ c a WBC là b t thư ng thì, R1, R2, R3, R4, RM s hi n th phía bên ph i

c a bi u đ đó.
R1 ch có b t thư ng phía bên trái c a LYM sóng đ nh, mà có th gây ra do tán huy t
không đ y đ c a RBC, c m ti u c u, ti u c u l n, plasmodium, có nhân h ng c u, t bào
lympho không bình thư ng, proteinic ho c h t m
R2 ch có b t thư ng trong khu v c gi a LYM sóng cao đi m và sóng MID, mà có th

gây ra b i các t bào lympho b nh lý, plasmocyte, không đi n hình t bào lympho, t
bào g c ho c tăng b ch c u ái toan và basophilia,
R3 ch có b t thư ng trong khu v c gi a MID sóng và GRAN sóng đ nh cao, mà có
th gây ra b i b ch c u h t non, b t thư ng ti u qu n th t bào, b ch c u ưa eosin.
R4 ch có b t thư ng phía bên ph i c a GRAN sóng đ nh cao, mà có th gây ra b i

s gia tăng tuy t đ i trong b ch c u h t.
RM ch có hai ho c nhi u hơn trư c báo đ ng.
Khi bi u đ PLT có b t thư ng, PM báo đ ng s đư c hi n th phía bên ph i.
PM ch có ranh gi i xác đ nh b b nh gi a PLT và RBC, mà có th gây ra b i s có

m t c a ti u c u l n, c m ti u c u, RBC nh , m nh v t bào ho c fibrin.
3.15 Result Analysis (Phân tích k t qu )
Chúng tôi cung c p các ch c năng phân tích k t qu nhi u

và thu n ti n
• Nh p vào “histo” đ thay đ i k t qu xét nghi m. Hãy tham kh o m c 3.18
trong chương này đ bi t chi ti t.
• Nh p vào “Trans” đ truy n d li u đ n m ng.
• Nh p vào “Print” đ báo cáo d li u in c a m u máu hi n t i b ng máy in

trong ho c máy in.ngoài
• Nh p vào “Mute” đ t t ho c âm thanh báo đ ng.
• Nh p vào “Tr giúp” đ có đư c s giúp đ c n thi t.
• “H” ho c “L” Hi n nay phía bên ph i c a các tham s có nghĩa là k t qu

là ra kh i ph m vi c a giá tr tham kh o. “L” có nghĩa là k t qu th p hơn
gi i h n th p hơn trong khi “H” có nghĩa là resuIt là cao hơn so v i gi i h n
trên.
• N u th i gian th p hơn, k so v i th i gian thi t l p h th ng, h th ng s báo

đ ng “bong bóng WBC” ho c “RBC bong bóng”, đ ng th i hi n th
“B” trư c khi k t qu xét nghi m.
• N u th i gian cao hơn, k so v i th i gian thi t l p h th ng, h th ng s báo

đ ng “làm t c ngh n WBC” ho c “RBC t c ngh n”, t i cùng m t th i
gian hi n th “C” trư c khi k t qu xét nghi m.
• B i vì màn hình l n c a t gi i h n, nó nên đư c thi t l p “Không” trong

System Setting đ t gi i h n đ u tiên, sau đó “L”, “H”, “B”,
“C” s xu t hi n.
3.18 T t máy
Th t c t t máy đư c th c hi n sau ho t đ ng hàng ngày và trư c khi t t. b o dư ng hàng

ngày và làm s ch các đư ng ng tránh đ ng các protein trong su t th i giankhông làm vi c
và gi cho h th ng s ch. th t c t t máy như sau:
1) T màn hình chính nh n "Exit", thông tin t t máy hi n th như hình 3-5.
Hình 7 Xác nh n t t máy
N u mu n t t máy nh n "Yes" Sau khi hoàn thành chu trình b o dư ng và làm

s ch trên màn hình xu t hi n thông báo "Thank you, and now turn off power"
Sau đó ngư i s d ng t t công t c t t máy phía sau máy
2) D n d p các khu v c xung quanh và x lý các ch t th i.

3) Nh n "No" N u không mu n t t máy.
Ghi chú: Th c hi n vi c t t máy không đúng quy trình có th làm gi m ch t lư ng máy

gây sai k t qu . T t c các thi t h i do quá trình s d ng sai s không đư c b o hành.
C nh báo: D li u có th b m t n u t t máy không đúng quy trình.

NOTE: If whole blood and capillary blood are both used in daily work, calibration
should be done after confirming the sampling mode.
NOTE: After confirming the mode, all test should be done in the same mode.
NOTE: If any malfunction occurs during measurement, the test results are invalid. Repeat the
measurement after troubleshooting.
7.2 Calib b ng tay
T i màn hình menu chính, b m vào nút “Cal” đ vào màn hình System Calibration. Ch n “Manual
Cal”, nh n “OK” đ vào giao di n chu n c a nhãn hi u. Nh p giá tr assay và Value1, sau đó
b m vào nút “New Cal”, h th ng s tính toán giá tr hi u chu n m i t đ ng và ngày s đư c
c p nh t cùng m t lúc. Xem Hình 7-1
Hình 8: Calib b ng tay
Nh p vào “OK” đ lưu các giá tr cân ch nh m i.

Nh p vào “Print” đ in các giá tr cân ch nh m i.
B m “Back” đ thoát kh i h th ng Cal.
Nguyên t c tính giá tr m i
o Giá tr calib m i = (giá tr đo đư c/giá tr mong mu n) x giá tr hi u chu n cũ
o N u giá tr m i nh hơn <70%, thì h th ng đ nguyên là 70% N u giá tr m i
>130%, thì giá tr m i l n nh t ch là 130%.
Lưu ý: h s hi u ch nh đư c cho phép trong ph m vi 70% ~ 130%, n u giá tr ki m tra
vư t quá gi i h n, giá tr quan tr ng này s đư c l a ch n như h s m i đ hi u chu n
Lưu ý: Analyzer có th hi u ch nh m t thông s nào đó ho c t t c các thông s c a
WBC, RBC,
HGB, MCV, MPV, RDW_CV, RDW_SD, PLT và PDW
C nh báo: D li u s b m t n u thoát ra mà không nh n “OK” đ lưu l i.
Calib t đ ng
T i màn hình menu chính, b m vào nút “Cal” đ vào màn hình System Calibration,
Ch n “Auto Cal ‘, b m vào nút” OK “đ vào giao di n hi u ch nh t đ ng. Xem Hình 8
Hình 8 Calibration t đ ng
T i Mode t đ ng Calibration, nh p vào giá tr xét nghi m sau đó đ t ng calibrator dư i kim
hút m u, nh n phím RUN, phân tích b t đ u đ m và sau đó hi n th các k t qu trong b ng
giá tr .
Analyzer không th đ m ho c hi n th các giá tr th nghi m trong đi u ki n sau đây:
1) Sau khi chi m 5 l n, nh n phím RUN, phân tích s nh c nh r ng không có không gian
đ x lý s hi u chu n.
2) N u đ chính xác c a k t qu ki m tra là b t thư ng, phân tích s nh c nh “d li u là

b t thư ng, xin vui lòng l i đ m”
3) Sau m i đ m, phân tích s tính toán m t giá tr hi u chu n m i theo giá tr tham kh o và
k t qu ki m tra và c p nh t ngày hi u chu n.
Nh p vào “Print” đ in các giá tr cân ch nh m i.

Nguyên lý tính toán giá tr m i:
• Giá tr trung bình c a giá tr m i:
• Giá tr calib m i = (Đo đư c/mong mu n) x giá tr cũ

• N u giá tr m i nh hơn <70%, thì h th ng đ nguyên là 70% N u giá tr
m i >130%, thì giá tr m i l n nh t ch là 130%.
NOTE: Nh p “OK” sau khi đo và sau đó h th ng s lưu các giá tr . Nh n “Back” mà
không nh n “OK”, giá tr s không đư c lưu.
B o dư ng, b o trì
Chăm sóc đ nh k và b o dư ng đ nh k là r t c n thi t đ gi cho hi u su t t i ưu, gi m

thi u các v n đ tr c tr c h th ng và kéo dài tu i th . Th t c và hư ng d n b o trì phòng
ng a đư c th o lu n trong ph n này. Xem thêm thông tin t i Trung tâm h tr khách hàng.
b o dư ng phòng ng a nên đư c th c hi n đ nh k . b o dư ng thích h p cũng đư c bao
g m trong chương này theo yêu c u th c t .
Chú ý: M t tiêu chí duy trì b n quy ph m c n ph i đư c th c hi n ch t ch đ tránh làm sai
l ch phân tích
C NH BÁO: Th c hi n b o v cá nhân trư c khi b o trì thi t b , ch ng h n như găng tay
m c, m t n và áo khoác phòng thí nghi m, vv
1. B o dư ng hàng ngày
Máy phân tích huy t h c t đ ng đư c thi t k v i các chương trình t đ ng b o dư ng

hàng ngày. Như th hi n trong hình 9, ngư i s d ng có th ch n th i gian t đ ng s ch đ
duy trì h th ng. Vui lòng tham kh o B ng 9-1 cho thi t l p th i gian.
Hình 9 Cài đ t l ch t b o dư ng
B ng 9-1 Cài đ t th i gian
2. B o dư ng hàng tu n
2.1 V sinh bên ngoài
Làm s ch các v t b n trên b m t thân máy, đ c bi t là máu đ trên đ u hút m u và xung

quanh đ lo i b s tích t protein ho c các c n v và làm gi m kh năng t c ngh n. Lau
s ch bên ngoài c a tàu thăm dò và xung quanh b ng g c t m b i khăn m m có t m ch t
t y nh
CAUTION: Không s d ng axit ăn mòn, dung môi h u cơ d bay hơi ho c ki m (như acet-
one, ether và chloroforms vv) đ làm s ch bên ngoài c a máy phân tích.
3 B o dư ng hàng tháng
B o trì hàng tháng ch y u nh m m c đích duy trì ho t đ ng cơ khí, bao g m c đ ng cơ

tr c bôi trơn, X, Y l y m u vv ..
LƯU Ý: Đ m b o t t máy trư c khi th c hi n b o trì hàng tháng
4 B o trì h th ng
T màn hình chính ch n nh n phím "Func", sau đó ch n "Maint" đ vào màn

hình như hình 10
Hình 10 H th ng b o trì
H th ng có th th c hi n 10 ch c năng b o trì như sau:
• R a khe đ m
• Bơm r a khe đ m
• X nư c kh i bu ng đ m
• R a CUP đ ng
• M i hóa ch t Lyse
• M i hóa ch t Diluent
• M i hóa ch t Detergent
• M i hóa ch t lên h t đư ng ng
• Đóng gói máy
4.1 Làm s ch khe đ m
Làm s ch khe đ m đ lo i tr kh năng làm t c khe đ m:

1. Ch n "Cauterize Aperture" t i màn hình Maintain.
2. Máy t đ ng th c hi n chu trình này, m t thanh bar s hi n th phía dư i đ

báo hi u ti n trình x lý.
3. Sau khi hoàn thành máy tr v màn hình Maintain.
4.2 Thông r a khe đ m
Thông r a khe đ m đ l i tr kh năng t c c a khe đ m và cũng là m t chu trình k t h p

v i làm s ch khe đ m. Trình t như sau:
1 Ch n "Flush Aperture" trên màn hình Maintain.
2. Máy t đ ng th c hi n chu trình thông r a, ti n trình x lý đư c th hi n b ng

thanh bar phía dư i c a màn hình.
3. Sau khi hoàn thành máy t đ ng tr v màn hình Maintain
4.3 V sinh c c đo
Th c hi n thao tác này đ đ h t hóa ch t Diluent ra kh i c đo WBC và RBC.

9.4.4 Rinse Cups
Th c hi n thao tác này đ r a khe đ m đ ngăn ng a t c ngh n khi đ m th i gian quá dài.
Th t c như sau:
1. Ch n “R a Cup” t i Duy trì màn hình.
2. Các phân tích b t đ u đ th c hi n các ch c năng và hi n th thanh ti n trình dư i

cùng c a màn hình.
3. Sau khi hoàn thành, h th ng này s tr v Duy trì màn hình.reen.
9.4.5 Rinse Fluidics

CAUTION: Consider all clinical specimens, controls and callibrators etc. that contain human
blood or serum as potentially infectious. Wear lab coats, gloves and safety glasses and
follow required laboratorial or clinical procedures when handling these materials.
CAUTION: As probe detergent is corrosive, operator should wear lab coats, gloves and
follow required laboratory operation procedures.
Probe detergent is a kind of alkalescence detergent. Prime Fluidics is to rinse WBC and
RBC cups as well as related tubings with probe detergent. If the analyzer keep) s on working
day by day, perform Prime Fluidics every 3 days; If not, perform this operation every week.
The procedure is as follows:
1) Place the probe detergent container under the aspiration probe. Select "Prime Fluidics"
at Maintain screen, then the dialogue box as Figure 9-3 will pop up, select "Yes" to
aspirate the detergent, select "No" to back to Maintenance screen.
Figure 9-3 Prime Fluidics Dialogue Box
2) Remove the detergent after the probe retracting back. Analyzer starts to perform the
function and display progress bar at the bottom of the screen.
3) After several seconds, the dialogue box as Figure 9-4 will pop up, put the probe
detergent container under the aspiration probe again then click “OK”.
Figure 9-4 Aspirate Detergent Dialogue Box

4) After completing, system will back to Maintain screen
9.4.6 Prime Lyse
CAUTION: Consider all clinical specimens, control and calibrator etc. that contain human
blood or serum as potentially infectious. Wear lab coats, gloves, and safety glasses and
follow required laboratorial or clinical procedures when handling thes materials
NOTE: Keep the lyse still for a certain time to ensure it stable
NOTE: After replacing diluents, detergent or lyse, perform background test to make sure the
background values are in a acceptable range.
Perform this operation in the following conditions,
• There are bubbles in the lyse tubing..
• Lyse have been contaminated.
• Replacement of lyse.
The procedure is as follows:
1) Select “Prime Lyse” in Maintain screen.
2) Analyzer starts to perform and display the progress bar at the bottom of the screen.
3) After completing, system will back to the Maintain screen.

CHAPTER 11 Troubleshooting
Chương này đưa ra ch d n đ xác đ nh, x lý s c và s a ch a l i l m. N u s c không

th đư c gi i quy t theo chương này ho c c n thêm thông tin, xin vui lòng liên h v i Trung
tâm h tr khách hàng.
11.1 Troubleshooting Guidance
Hư ng d n kh c ph c s c đư c thi t k đ h tr các ngư i s d ng xác đ nh và gi i quy t

các l i phân tích. Nó cũng cung c p hư ng d n v vi c thu th p h tr k thu t t Trung tâm
h tr khách hàng. Bư c đ u tiên là ph i hi u đư c ho t đ ng bình thư ng và b o dư ng
phòng ng a c a phân tích. Kiinh nghi m là đi u c n thi t đ x lý s c , Gi i quy t s c có
th đư c chia thành 3 bư c sau:
Bư c 1: Xác đ nh sư c :
Ngư i s d ng c n ph i có kh năng xác đ nh nguyên nhân l i đ có th x lý 1 cách
chính xác nh t.
Bư c 2 Khoanh vùng s c :
S c ti p t c đư c phân vùng theo các th lo i:
a) Lõi liên quan đ n ph n c ng

b) L i liên quan đ n ph n m m
c)L i liên quan đ n phân tích b nh ph m
Ph n c ng và ph n m m l i ch có th đư c s a ch a b i m t k sư đư c y quy n. Trong
khi l i liên quan đ n phân tích m u có th đư c x lý b i ngư i s d ng v i s h tr c a
các k sư.
Bư c 3 Cách kh c ph c:
Hành đ ng kh c ph c có nghĩa là hành đ ng thích h p đ s a l i. N u ngư i s d ng có

th s a l i có ho c không có h tr k thu t t các k sư, th i gian có th đư c gi m
đáng k .
11.2 Obtaining Technical Assistance
If technical assistance is needed, please contact the Customer Support Centre. Refer to
Copyright and Declaration for Tel. number and fax number User should provide detailed and
clear faults description. Requirements are as follows:
a) Model;
b) Serial number and version number;
c) Description of fault and operation environment (for example, the fault happened in which
screen status);
d) Lot numbers of reagents (lyse, diluents and detergent etc.);
e) Related data and report
Familiar faults and corrective actions are also given in this Chapter. Operator can identify the
fault cause according to warning information and correct the fault follow Troubleshooting
Guide.
11.3 Troubleshooting
Các l i thông thư ng và hành đ ng kh c ph c đư c li t kê như sau. N u l i v n

không th đư c s a ch a theo chương này, g i h tr k thu t là c n thi t, xin vui
lòng liên h v i Trung tâm H tr Khách hàng NeoMedica.
L i liên quan đ n hóa ch t
L i Nguyên nhân Cách kh c ph c
H t hóa ch t Lyse 1.Ki m tra đư ng ng và hóa ch t.

Lyse empty ho c b k t ng 2.Th c hi n→Prime Lyse.
3.N u không gi i quy t đư c thì liên h NEOMEDICA.
1.Ki m tra đư ng ng và hóa ch t.

H t hóa ch t
Diluent empty 2.Th c hi n→Prime Diluent.
Diluent
3.N u không gi i quy t đư c thì liên h NEOMEDICA..
1.Ki m tra đư ng ng và hóa ch t.

H t nư c 2.Th c hi n→Prime Detergent.
Detergent empty
r a 3.N u không gi i quy t đư c thì liên h NEO-
MEDICA.
Đ y nư c th i 1.Ki m tra bình nư c th i.

ho c sensor b 2.Ki m tra sensor có th b ư t ho c h ng.
Waste full
l i 3.N u không gi i quy t đư c thì liên h
NEOMEDICA
11.3.2 Faults Relate to Vacuum
Fault Probable Cause Correction Action
Áp l c âm không đ t 1.Nh n “Sev”, nh p mã “2006” đ ki m tra tình tr ng

giá tr yêu c u 2. .N u không gi i quy t đư c thì liên h
Low Vaccum NEOMEDICA
L i liên quan đ n đi n áp 5V
11.Nh n “Sev”, nh p mã “2006” đ ki m tra tình

H th ng ngu n b l i tr ng
5V Voltage
2. .N u không gi i quy t đư c thì liên h
Problem
NEOMEDICA
L i liên quan đ n k t qu
L i Nguyên nhân Cách x lý
1. Ki m tra l i hóa ch t Diluent

Diluent b b n ho c
2. Vào màn hình Mainain th c hi n “Rinse Fluidics”;.
đã quá h n
Giá tr Back 3. N u v n t n t i l i, Th c hi n m i hóa ch t v i nư c r a
Đư ng ng ho c
ground quá vào v trí kim hút th c hi n ch y Background 1 l n n a;.
cup đo Diluent b
l n 4. N u l i v n t n t i vui lòng liên h v i NEOMEDICA.
b n
1. Nh n “Sev”, Nh p mã “2006” vào màn hình System ki m

đi n áp c a
HGB Sai tra “HGB_BACK” và “HGB_ZERO”;.
HGB t i
2. N u “HGB_BACK” và “HGB_ZERO” ngoài d i, liên h
background
v i NEOMEDICA đ thay đ i giá tr .
b nh y
Khe đ m b 1. Th c hi n “Cauterize Aperture” ho c” Flush Aperture”

t c; WBC trong ph n Maintain, ch y background đ ki m tra th i
WBC clog th i gian đ m gian đ m.
or RBC clog b t thư ng; 2. N u l i v n còn th c hi n Prime Fluidics trong ph n
van có v n đ Maintain.
3. N u l i v n t n t i vui lòng liên h v i NEOMEDICA.
Diluent ho c
detergent
1. Ki m tra diluent ho c detergent.
không có ng
WBC bubble 2. KI m tra k t n i ng, ngăn ng a các rò r .
d n hóa ch t
or RBC bubble 3. Th c hi n Rinse Fluidic trong ph n Maintain;.
b l ng d n
4. N u l i v n t n t i vui lòng liên h v i NEOMEDICA.
đ n b rò r
Liên quan đ n ph n c ng

1. Dây đi n đư c
k t n i không t t 1. Ki m tra dây n i ngu n đi n
Không b t v i các c m 2. Ki m tra tình tr ng c u chì.
đư c máy đi n. 3. N u l i v n t n t i thì hãy t t máy và liên l c v i NEO-
2.The c u chì có MEDICA.
th đ t.
1.Mô tơ k t n i
l ng;
1.Nh n “Sev”, Nh p mã “2006” đ vào ki m tra tình tr ng
2.Có v n đ v i r
Mô tơ có ho t đ ng c a mô tơ;
c m bi n quang
ti ng kêu l 2 N u l i v n t n t i thì hãy t t máy và liên l c v i
3.L i Mô tơ;
NEOMEDICA.
4.M ch đi u khi n
Mô tơ l i
1. Lo i b hóa ch t kh i cup đ ng, tháo khe đ m ra v

sinh và là s ch. l p l i khe đ m và ch y chu trình back-
ground vài l n đ ki m tra đ t c.
1.Khe đ m b
Th i gian 2. Nh n “Sev”, Nh p mã “2006” đ vào ki m tra tình tr ng
t c
đ m quá dài ho t đ ng c a các van;
2.van không
ho c không 3. N u l i v n t n t i thì hãy t t máy và liên l c v i NEO-
ho t đ ng.
có th i gian MEDICA.
đ m
Liên quan đ n nhi t đ

1.Nh n “Sev”, nh p mã “2006” đ vào màn hình
System Check, ki m tra nhi t đ trong m c System
Nhi t đ b t
Status Check.
thư ng ho c c m
Nhi t đ b t 2. N u nhi t đ môi trư ng v t qua ngaoif giá tr cho
bi t b l i
thư ng phép t 15°C÷30°C, hãy thay đ i nhi t đ mô trư ng
cho phù h p v i yêu c u c a máy.
2. N u l i v n t n t i thì t t máy và liên h v i
NEOMEDICAL
PHOENIX NCC-51
Five-Part-Diff Auto Hematology
Analyzer
Operation Manual
NOTE:
1) Carefully read this manual before first operating the analyzer.

2) Inspect the electrical requirements of the analyzer before power on,
and properly connect the grounding wire.
3) Turn off the power to the analyzer and disconnect the power cord if the
analyzer is idle for a long time.
4) Do not run the analyzer if it’s in an abnormal or damaged condition.
5) There is potential biohazard of the reagents and samples; operator
should follow proper biosafety practices. Dispose of waste reagent and
sample in accordance with local, national regulations.
Contents
Chapter 1 Introduction................................................................................................................... 1
1.1 Overview .......................................................................................................................... 1
1.2 How to Use This Manual .............................................................................................. 2
1.3 Hazard Sign ..................................................................................................................... 2
1.4 Guidance .......................................................................................................................... 2
1.5 Parameters ...................................................................................................................... 3
Chapter 2 Safety Information for Operation................................................................................ 5
2.1 Overview .......................................................................................................................... 5
2.2 Special Requirements .................................................................................................. 5
2.3 General Requirements.................................................................................................. 5
2.4 Electromagnetism Security......................................................................................... 6
2.5 Installation ....................................................................................................................... 6
2.6 Prevent Infected ............................................................................................................. 7
2.7 Reagent ............................................................................................................................ 7
2.8 Maintenance .................................................................................................................... 8
2.9 Laser ................................................................................................................................. 8
2.10 Consumables................................................................................................................ 8
2.11 Security Sign ................................................................................................................ 9
2.12 Operators....................................................................................................................... 9
2.13 Computer Virus .......................................................................................................... 10
Chapter 3 System and Function................................................................................................... 11
3.1 Overview ........................................................................................................................ 11
3.2 Parameter ...................................................................................................................... 11
3.3 Structure ........................................................................................................................ 12
3.4 Counting Operation Screen ...................................................................................... 19
3.5 Reagent, Control and Calibrator .............................................................................. 20
3.5.1 Diluent ................................................................................................................. 21
3.5.2 Sheath ................................................................................................................. 21
3.5.3 Detergent ............................................................................................................ 21
3.5.4 Probe Detergent ................................................................................................ 22
3.5.5 Lyse ...................................................................................................................... 22
3.5.6 Control and Calibrator .................................................................................... 22
Chapter 4 Installation ................................................................................................................... 24
4.1 Overview ........................................................................................................................ 24
4.2 Unpacking and Inspection ........................................................................................ 24
4.3 Space Requirements ................................................................................................... 25
4.4 Power Supply Requirements .................................................................................... 25
4.5 Environment Requirements ...................................................................................... 25
4.6 Waste Requirements ................................................................................................... 26
4.7 System Installation ...................................................................................................... 26
4.7.1 Computer Installation ...................................................................................... 26
Contents
4.7.2 Tubing Installation............................................................................................ 27

4.7.3 Printer Installation ............................................................................................ 28
4.8 Transport and Storage Requirement ...................................................................... 28
Chapter 5 Principles of Operation............................................................................................... 29
5.1 Overview ........................................................................................................................ 29
5.2 Sample Aspiration ....................................................................................................... 29
5.3 Sample Dilution ............................................................................................................ 29
5.3.1 Whole Blood Open Type Sampling Mode .................................................. 30
5.3.2 Pre-dilution Sampling Mode .......................................................................... 31
5.4 WBC Test Principle ..................................................................................................... 32
5.4.1 Four-Angle Laser Light Scatter Technology ............................................. 32
5.4.2 White Blood Cell Differential ......................................................................... 35
5.5 Hemoglobin Concentration Test Principle ............................................................ 36
5.5.1 Colorimetry Principle ...................................................................................... 36
5.5.2 HGB Parameter ................................................................................................. 36
5.6 Red Blood Cell /Platelet Test Principle .................................................................. 37
5.6.1 Electrical Impedance Principle ..................................................................... 37
5.6.2 Volumetric Metering......................................................................................... 38
5.6.3 Red Blood Cell Parameters............................................................................ 38
5.6.4 Platelet Parameters .......................................................................................... 40
Chapter 6 Settings ......................................................................................................................... 41
6.1 Overview ........................................................................................................................ 41
6.2 Time Setting .................................................................................................................. 41
6.3 System Maintenance .................................................................................................. 42
6.5 Display Setting ............................................................................................................. 48
6.6 Print Setting .................................................................................................................. 49
6.8 Group Parameters ....................................................................................................... 52
6.8.1 Limit Review ...................................................................................................... 52
6.8.2 Limit Modification............................................................................................. 54
6.9 User Management........................................................................................................ 54
6.10 Permission .................................................................................................................. 55
Chapter7 Daily Operation ............................................................................................................ 57
7.1 Overview ........................................................................................................................ 57
7.2 Preparations.................................................................................................................. 57
7.3 Startup ............................................................................................................................ 58
7.4 Quality Control ............................................................................................................. 59
7.5 Collection of Blood Samples .................................................................................... 60
7.5.1 Whole blood collection ................................................................................... 61
7.5.2 Pre-dilution sample preparation ................................................................... 61
7.5.3 Sample stability ................................................................................................ 62
7.6 Information Input ......................................................................................................... 62
7.7 Sample Counting ......................................................................................................... 64
7.7.1 Mode .................................................................................................................... 64
7.7.2 Counting and Analysis.................................................................................... 65
Contents
7.8 Data Query and Output .............................................................................................. 65

7.8.1 Data Query ......................................................................................................... 66
7.8.3 Data Deletion ..................................................................................................... 71
7.8.4 Repeatability ...................................................................................................... 71
7.8.5 Data Comparison .............................................................................................. 72
7.9 Reticulocyte Analysis ................................................................................................. 73
7.9.1 Principles of Operation ................................................................................... 74
7.9.2 Reticulocyte Sample Preparation................................................................. 76
7.9.3 Reticulocyte Test .............................................................................................. 76
7.10 Statistic ........................................................................................................................ 78
7.11 Shutoff .......................................................................................................................... 79
Chapter 8 Quality Control ........................................................................................................... 80
8.1 Overview ........................................................................................................................ 80
8.2 Quality Control Options ............................................................................................. 81
8.3 QC Mode Selection...................................................................................................... 82
8.4 L-J QC ............................................................................................................................. 82
8.4.1 L-J QC Edit ......................................................................................................... 82
8.4.2 L-J QC Run ......................................................................................................... 84
8.4.3 L-J QC Graph Analysis ................................................................................... 85
8.4.4 L-J QC Data Query ........................................................................................... 85
8.5 X-B QC ............................................................................................................................ 86
8.5.1 X-B QC Edit ........................................................................................................ 86
8.5.2 X-B QC Run ........................................................................................................ 87
8.5.3 X-B QC Graph Analysis .................................................................................. 87
8.6 X-R QC ............................................................................................................................ 88
8.6.1 X-R QC Edit ........................................................................................................ 88
8.6.2 X-R QC Run ........................................................................................................ 90
8.6.3 X-R QC Graph Analysis .................................................................................. 90
8.6.4 X-R QC Data Query .......................................................................................... 91
8.7 X QC ................................................................................................................................ 92
8.7.1 X QC Edit ............................................................................................................ 92
8.7.2 X QC Run ............................................................................................................ 94
8.7.3 X QC Graph Analysis ....................................................................................... 94
Chapter 9 Calibration................................................................................................................... 96
9.1 Overview ........................................................................................................................ 96
9.2 Calculate Frequency ................................................................................................... 97
9.3 Preparation for Calibration........................................................................................ 97
9.4 Calibration Mode.......................................................................................................... 98
9.4.1 Calibrated Calibration ..................................................................................... 98
9.4.2 Whole Blood Calibration .............................................................................. 101
9.4.3 Manual Calibration ......................................................................................... 104
Chapter 10 Maintenance and Care............................................................................................ 106
10.1 Overview .................................................................................................................... 106
10.2 Routine Maintenance .............................................................................................. 106
Contents
10.2.1 Daily Maintenance........................................................................................ 106

10.2.2 Weekly Maintenance.................................................................................... 107
10.2.3 Monthly Maintenance .................................................................................. 108
10.3 Maintenance procedure ......................................................................................... 110
10.3.1 Fluidics Cleaning ......................................................................................... 111
10.3.2 Diluent Replacement ................................................................................... 112
10.3.3 Detergent Replacement .............................................................................. 113
10.3.4 Sheath Replacement ................................................................................... 113
10.3.5 Cauterize Aperture ....................................................................................... 113
10.3.7 Clean Transducers ....................................................................................... 114
10.3.8 Prepare Shipping.......................................................................................... 115
10.3.9 Other Maintenances .................................................................................... 116
Chapter11 Troubleshooting ........................................................................................................ 118
11.1 Overview .................................................................................................................... 118
11.2 Troubleshooting Guidance ................................................................................... 118
11.3 Obtaining Technical Assistance .......................................................................... 119
11.4 Troubleshooting ....................................................................................................... 119
11.4.1 Faults Related to Reagents ........................................................................ 119
11.4.2 Faults Related to Test Value ...................................................................... 120
11.4.3 Fault Related to Hard Ware ........................................................................ 121
Appendix A Specifications .......................................................................................................... 122
A.1 Technical Specifications ......................................................................................... 122
A.1.1 Parameters ...................................................................................................... 122
A.1.2 Test Speed ....................................................................................................... 122
A.1.3 QC Mode .......................................................................................................... 123
A.1.4 Reagents of Product ..................................................................................... 123
A.1.5 Calibration Mode............................................................................................ 123
A.1.6 Parameters Measurement and Calculation ............................................. 123
A.1.7 Input/output Devices..................................................................................... 123
A.2 Physical Specifications ........................................................................................... 124
A.2.1 Power Requirement....................................................................................... 124
A.2.2 Environment Requirement .......................................................................... 124
A.2.3 Storage Environment .................................................................................... 124
A.2.4 Size and Weight ............................................................................................. 124
A.2.5 Waste Disposal ............................................................................................... 124
A.2.6 Minimum Sample Volume ............................................................................ 124
A.2.7 Dilution Ratio .................................................................................................. 124
A.2.8 Counting Aperture ......................................................................................... 124
A.2.9 HGB measurement ........................................................................................ 124
A.3 Performance Index ................................................................................................... 125
A.3.1 Precision .......................................................................................................... 125
A.3.2 Linearity ........................................................................................................... 125
A.3.3 Accuracy of WBC five part differential ..................................................... 125
A.3.4 Carryover ......................................................................................................... 125
Contents
A.3.5 Background Counting .................................................................................. 125

A.3.6 Accuracy .......................................................................................................... 126
A.3.7 Display Range of Main Parameter ............................................................. 126
A.4 Reagent Specifications ........................................................................................... 126
A.5 Reagent Consumption ............................................................................................. 126
A.6 Parameters Alert Messages ................................................................................... 127
Appendix B External communication protocol ........................................................................ 128
Appendix C License for Manufacturing Measuring Instruments .......................................... 139
Appendix D Toxic and Hazardous Substances or Elements .................................................... 140
Appendix E Daily Operation Procedure ................................................................................... 141
Copyright and Declaration
Copyright © NeoMedica DOO.
Declaration:
All contents in this manual were strictly compiled according to related laws and
regulations in Serbia, as well as the specific condition of PHOENIX NCC-51
Auto hematology Analyzer, covering all the updated information before printing.
NeoMedica DOO is fully responsible for the revision and explanation of the
manual, and reserves the right to renovate the relevant contents without
separate notification. Some of the demonstration pictures are for reference
and subject to real object if any differences.
All the information included is protected by copyright. No part of this document
may be reproduced, stored or transmitted in any form or by any means unless
written authorization by NeoMedica DOO
All instructions must be followed strictly in operation. In no event should
NeoMedica DOO be responsible for failures, errors and other liabilities
resulting from user's noncompliance with the procedures and precautions
outlined herein.
Limited Responsibility for Quality Warranty:
The manual for PHOENIX NCC-51 Auto Hematology Analyzer, defines the
rights and obligations between the NEOMEDICA and the customers about the
responsibility for quality warranty and after-sale service, also the related
agreements on commencement and termination.
NEOMEDICA warrants the PHOENIX NCC-51 sold by the NEOMEDICA and
its authorized agents to be free from defects in workmanship and materials
during normal use by the original purchaser. This warranty shall continue for a
period of one year since the date of installation. The analyzer life is ten years.
NEOMEDICA assumes no liability in the following situations even during the
period of warranty:
a) Failure due to abuse the analyzer or neglect the maintenance.
b) Use reagents and accessories other than manufactured
or recommended by NEOMEDICA.
c) Failure due to operation not under the instructions described in the
manual.
d) Replace accessories not specified by NEOMEDICA, or after
maintenance or repair by a service agent not approved or authorized by
NEOMEDICA.
CAUTION:
THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE
ONLY.
Technical service and troubleshooting are provided by NEOMEDICA Customer
Support Center. Professional technician and sale representative will be sent to
offer you timely service when necessary.
NeoMedica DOO
Bul. Cara Konstantina 82-86, 18000 Niš, Serbia
Tel: +381 (18) 573-820, +381 (18) 573-606, +381 (18) 533-935
Fax: +381 (18) 573-616
Web: www.NeoMedica.rs
Email: info@NeoMedica.rs
Supplyed by NeoMedica DOO
Wellkang Ltd t/a Wellkang Tech Consulting

Suite B 29 Harley Street, LONDON W1G 9QR, UK
Version : V15.05
Chapter 1 Introduction
1.1 Overview
Welcome to read the Five-Part-Diff Auto Hematology Analyze’ s manual,
this manual including instrument operation, maintenance instructions and
matters needing attention, in order to keep the instrument has a good
performance, you must according to this manual to do the operation and
maintenance.
NCC-51 Five-Part-Diff Auto Hematology Analyzer is an in vitro diagnostic
medical device. It can analyze and output 34 parameters of the specimen
(including 6 graphics). The Optical detection section uses semiconductor
laser to analyze the five part differential of white blood cells, Coulter
theory to analyze red blood cells，platelet, and uses colorimetry for
hemoglobin concentration
NOTE
 Read this instruction carefully before operating, especially the safety
information. Please keep this manual properly for future reference.
 If the user does not operate the instrument according to operation manual,
misemployment will lead to inaccurate measurement and cause
misdiagnosing, delaying patient’s treatment or doing harm to the operator
himself, even damaging the instrument.
 Any attempt to brief, optimize, improve or elide expected activities which
listed in operation manual will be likely to cause some negative impact on
the precision of instrument.
 User must follow the instruction strictly when he operating the NeoMedica
medical instrument.
Maintenance Chapter 10 Maintenance and Care

Troubleshooting Chapter 11 Troubleshooting
Detailed Specification Appendix A
Communications Protocol Appendix B
Metrical Information Appendix C
Name and content of poisonous and
Appendix D
harmful substances or elements
Daily operation procedures Appendix E
1.5 Parameters
Item Content Explanation

Test 34 parameters(with Scatter diagram, histogram, three
Parameter graphics) dimensional stereogram
Open type sample
Operation Only need 20µL Blood sample for test
injection mode
Software supports online and U disk
Language English
upgrade.
Equipped with brand
Display Data management and networking are
computers and LCD
Setting convenient.
monitors .
Data
≥ 200 000 test results (with graphics )
Storage
Speed ≥ 60 / h
External printer,
choose to print the
histogram. Different
Output Reference range can be printed out
warning signs prompt
Mode in English report format.
probable
abnormalities of
spec imen.
Whole Blood Sampling
Blood Mode 20 µL Anticoagulation with
Volume EDTA-K2/EDTA-K3.
Pre-dilution Sampling
Mode 20 µL
Diluent, detergent, Detergent (non-toxic environment-friendly
Reagent
reagents), sheath
Use the automatic
Sample washing device to
Aspiration flush the inside and Avoid s amples c ross c ontamination
Probe outside wall of and operators contact the samples.
Rinsing sample aspiration
probe.
Prec ision stepper

Blood High precision and Wear
motor sample
Separation resistance
aspiration
With two units selection
Unit Meet the parameters unit requests
for WBC, RBC, HGB, PLT
Selection for different countries and places.
and other items.
Cyanide-free
quaternary Environmental regents c an avoid the
ammonium salt effects of operators' health, and be
hemoglobin. good for environmental protection. If
HGB Test LED light source, use the toxic reagents, you need to
540nm wavelength purchas e specialist processing
colorimetry. equipment, which will increase
c osts .
Control and With calibrator, fresh blood and manual calibration; With LJ, X, XR, XB
Calibration control mode etc.
WBC ≤1.5% WBC： 0.0×109 /L -99.9×109 /L
RBC ≤1.0% RBC：0.1×1012 /L -7.00×1012 /L
Coefficient HGB ≤1.0% Linear HGB： 0 g/L-300g/L
of Variation MCV ≤1.0% ity
HCT ≤1.0% PLT： 0×109 /L -999×109 /L
PLT ≤4.0%
Adopt separately
Structure Enhance accuracy and maintain
removable syringe
easily
structure.
With automatic monitoring
function to prompt the
Improve the lifetime of equipment,
Maintenanc operator to perform
and maintain the best working
e automatic maintenance or
conditions
troubleshooting
procedures.
Can be adjusted according to different
With 9 different groups
Reference geographical groups; and the instrument will
normal range parameter
Range automatically identify and match the best
setting function.
reference.
High-voltage cautery. Removable ruby aperture plate is easy to clean.
Flush
Positive and negative pressure recoil and intelligent automatic cleaning.
Sec urity Have a good electrical security with the flow electricity isolation system.
Host Size L598.5mm×W585mm×H488.5mm
Power ≤250VA
Fuse 250V/3.15A
weight 65kg
Chapter 2 Safety Information for Operation
2.1 Overview
In addition to the safety use information, the general matters of operators
in terms of security are also shown in this chapter. Please read this chapter
carefully before operation.
2.2 Special Requirements

 NCC-51 Five-Part-Diff Automated Hematology Analyzer is for blood cell
count, WBC five part differential and hemoglobin concentration
measurement in clinical laboratory.
 Only allow to use the reagents and detergents mentioned in this manual.
Operating requirements also include regular cleaning and maintenance.
2.3 General Requirements

 Read the operation manual before using. Understand all the important
signs. Please keep manual for future reference.
 Following the manual instructions to start the analyzer, otherwise the
functions of the analyzer will lose due to accidental mechanical damage
and undesirable environment.
 The instrument must be operated in accordance with the methods
mentioned in this manual strictly.
 Keep long hair, fingers and clothes away from rotating parts with a certain
distance.
 Turn off the power switch and unplug the power cord immediately if the
instrument gives off odor or smoke, otherwise it will cause fire, electric
shock or injury. If this happens, please contact the after-sale service
department.
 Do not spill the samples or reagent and do not let other things to fall into
the instrument, otherwise it will cause short circuit. If this happens, turn off
the power switch and unplug the power cord immediately, then contact the
after-sale service department.
 Do not touch the circuit, especially a wet hand, which will cause electric
shock.
 The analyzer must be connected to a receptacle with correct voltage, and
grounding at the same time.Avoid damaging the power cord. Do not put
 any device upon the power cord. Do not pull the power cord.
 Turn off the power before connecting other devices (host computer,
printer).
 The instrument is connected with AC power. There is a hazardous voltage
symbol in the interface. Using power adapters of other brands may cause
wrong test results due to the substandard technique data
2.4 Electromagnetism Security

 The motor is inside the instrument, it will produce alternative electric field
and magnetic field.
 The instrument may not function properly due to the strong
electromagnetic interference.
 It may cause data conversion errors and incorrect results due to strong
electromagnetic interference and poor grounding.
2.5 Installation
 The analyzer must be installed in dry and dust-free place. Avoid placing in
the place where is wet and with poor ventilation or in the dirty air with salt
and sulfur. Since the shell material is ABS + PC, it will be corrupted if being
placed in a high pH environment.
 Avoid splashing water on the analyzer.
 Do not expose the instrument to the place with large temperature
difference and direct sunlight.
 Avoid vibration. The instrument should be put into the box with foam to
prevent damage during storage and transport. Improper package may lead
to abnormal operation of the instrument.
 Installation site must be well ventilated.
 This instrument does not produce ionizing radiation, but we should take
other equipment that generate strong ionizing radiation into consideration,
such as X-ray, γ-ray which may cause test results errors.
 The equipment should not be installed in the place where stores chemicals
and generates gas.
 The frequency and voltage required should be consistent with those in the
instruction and have the ability to allow current. The instrument should be
equipped with precision power supply or UPS.
 The equipment is about 65kg, falling may cause injury during carrying.
 Wrong reagent or incorrect operation may cause wrong results.
2.6 Prevent Infected

 All the components and surface of the instrument have the potential
infectivity. The sample probe should keep an appropriate distance from the
surrounding objects in order to facilitate running.
 Wear protective clothing and rubber gloves during operation, maintenance,
service or repair. Wash hands with disinfectant after work.
 Do not contact the waste and its components with free hands.
 If accidentally exposed to infectious material or surface, thoroughly clean
the skin with water immediately, and then operate according to the
laboratory disinfection procedures.
 Instrument uses blood as samples. Blood may contain microbial
pathogens which can cause infection easily. Therefore, operation must be
done carefully, if necessary, wear protective gloves to prevent the operator
himself and people around being infected by pathogenic microorganisms.
Even the control and calibrator can be infectiously; we should wear
protective clothing and rubber gloves during calibration.
2.7 Reagent
 Check marks on the package.
 Avoid direct contacting with reagents, since the reagents may irritate eyes,
skin and mucous membranes.
 If skin contacts with the reagent, rinse it with plenty of water immediately.
 If eye contacts with the reagent, rinse it with plenty of water and seek
medical advice immediately.
 Establish a set of emergency measures in laboratory is very necessary.
 Protect the reagents from being polluted by dust, dirt and germs.
 Reagents must be used within the validity period.
 Handle the reagents properly to prevent bubble. Do not shake! The
reagent cannot be used immediately after transport.
 Do not let the reagents spilt. If it happens, wipe away with a cloth.
 If you swallow reagents accidentally, please seek the medical attention
immediately.
 Diluent is a kind of good conductor, if being spilt next to the wire or device,
it may cause electric shock. Please turn off the power, unplug the plug and
clean the diluent.
 The probe cleaning solution or detergent is strongly alkaline cleaner. Do
not let it contact the skin or clothes. If that happens, rinse the skin and
clothes with plenty of water immediately.
 Probe cleaning solution contains sodium hypochlorite. If it contacts the
instrument surface, wipe up with a cloth immediately, otherwise it will
corrode the surface.
 Ensure that the reagents keep the same level with the instrument or lower.
Do not put reagents on the top of the instrument.
2.8 Maintenance
 As a precision electro-optical instrument, maintenance is necessary for
normal operation. The test data may have small deviations without regular
cleaning. In rare cases, operator might be infected due to poor cleaning.
 To prevent infection, electric shock and burn, operator must wear rubber
gloves in maintenance work. Wash hands with disinfectant after work.
 Use special tools for maintenance.
 All the cleaning and maintenance procedures must be in accordance with
the manual operation.
 Do the daily, weekly, monthly maintenance in accordance with the manual
operation.
 If the instrument is not used for a long time, empty the rinsing flow
according to the procedure before disuse. Ensure the instrument is in a
good working condition before reuse.
 Reinstallation can only be done when replacing standby parts.
2.9 Laser
The instrument uses semiconductor laser, the laser is protected by a
shield. If you remove the shield, the laser may burn your eyes and cause
harmful radiation. Only the service technician assigned by NeoMedica can
open the lid.
2.10 Consumables
The disposal of residual reagents, cleaning agent and all waste must
comply with local laws and regulations. Used samples and reagents should be
separated from ordinary waste, or they may cause environmental pollution.
exclusively. If being operated incorrectly by non-skilled staff,

misemployment will lead to inaccurate measurement and cause
misdiagnosing, delaying patient’s treatment or doing harm to the operator
himself, even damaging the instrument.
 Failing to operate in accordance with instruction will lead to incorrect
operation, such as test parameter setting error. It may damage the
instrument and result in wrong diagnosis results.
 Maintenance should be carried out by professional technicians. It will
cause test errors result from unauthorized technicians and nonstandard
maintenance.
 Invalid hardware / software will affect the accuracy of test results. The
operator needs to contact the after-sale service personnel as soon as
possible.
2.13 Computer Virus
CAUTION
 Although our software has been checked to make sure there is no computer
virus, some measures must be considered in the daily operation. Here are
some checking procedures, but not completed. Depending on your
working conditions to choose appropriate measures:
1. Use a virus checker program for regularly checking.
2. Do not install other application program except virus checker program.
3. Do not open unknown email attachments.
4. Do not download any file which has nothing to do with the software program.
5. Check files in the folder for anti-virus.
6. Do not use U disk or other storage media on the computer to prevent them
bringing virus to the computer.
Chapter 3 System and Function
3.1 Overview
NCC-51 Five-Part-Diff Auto Hematology Analyzer is a vitro diagnostic
medical device. It is used for blood cell count, WBC five part differential and
hemoglobin concentration measurement in clinical tests. This instrument can
provide the accurate test data of human venous blood, which provide the
necessary reference for clinical diagnosis.
The instrument provides a fast count, all operations (including sampling,
measurement and results output) are fully automated. The instrument will
automatically start counting when detecting the samples. About 60
seconds, three-dimensional graphics data and results can be displayed
in the LCD screen. The results can be printed or transmitted to the LIS
system.
The biggest feature of the instrument is that as long as 20µL blood sample,
the white blood cells can be analyzed and then gives WBC five part differential
results.
3.2 Parameter
The instrument can analyze and arrange the samples data automatically
and shows the blood cell and white blood cell 5 part differential count
respectively. Also, it will give the three-dimensional plot and scatter diagram of
white blood cells and histogram of red blood cells and platelet.
The NCC-51 generates the following 34 test parameters in table
3-1(including two histograms, two three-dimensional plots and two scatter
diagrams).
Table 3-1 Parameters
MON% Monocyte Percent %
NEU% Neutrophil Percent %
EOS% Eosinophil Percent %
BAS% Basophil Percent %
MON# Monocyte Count 109cells/L
NEU# Neutrophil Granulocyte Count 109cells/L
EOS# Eosinophil Granulocyte Count 109cells/L
BAS# Basophil Granulocyte Count 109cells/L
HGB Hemoglobin g/L

RDW_CV Red Blood Cell Distribution Width repeat precision %
PCT Plateletcrit %
P_LCC Large Platelet Count 109cells/L
P_LCR Large Platelet Percent %
RETIC Reticulocyte %
RETIC_ABS Reticulocyte absolute number 109/ul
IRF Immature Reticulocyte Fraction %
Remark: PCT and PDW are the inferred parameters. They are provided for
laboratory use only.
3.3 Structure
CAUTION
 The instrument needs several people work together to move since it is

relatively large. Please use proper tools and follow relevant safety code
when moving.
 Take out the instrument and then check whether the appearance is intact.
Ensure there is no damage during transport.
The analyzer is consisted of host, computer and an external printer
(optional).
Host is mainly composed of laser parts, automatic sampler, Syringe
Mechanism, A/D and the central control panel, the WBC measurement unit,
RBC/PLT measurement unit, liquid system, display screen and other parts,
accessories including the power cord, ground wire, etc.
12
Figure 3-1A Front View

1--- Counting Button Switch
13
Figure 3-1B Front View (Remove the front cover)
1--- Automatic Sampler

2--- Syringe Mechanism
3--- Solenoid Valve
4--- Optical reagents connectors
14
Figure 3-2 Right Side View (Remove the right side door)
1--- Automatic Sampler

2--- Specimen Cup
3--- Optical Path module Inside
4--- Syringes Module
5--- Fluid Reservoir
15
Figure 3-3 Left Side View (Remove the Left side door)
1--- Circuit board

2--- Serial Port and USB Interface
3--- Switching Power Supply
4--- Power Socket
5--- Power Switch
16
Figure 3-4 Rear View
1---Cooling Fan
2---Liquid Flow System baffle
17
Figure 3-5 Vertical View（Optical Bench）
WARNING
 Semiconductor Laser is above the instrument. Do not open the upper cover
for your safety, only the authorized personnel authorized by UNIT can open
it.
18
3.4 Counting Operation Screen

After startup, the instrument will enter into the count screen automatically.
Figure 3-6 Counting interface
This interface can be divided into the following areas by functions:

1. Main Menu Area
By clicking the button, operator can enter into corresponding interface to achieve
the functions. Please refer to the followin table to select the appropriate button.
Table 3-2 Main Menu Button
Button Function
Test Counting operations
Data Query the test results
Maintenance Replacement of reagents, maintenance of equipment
QC Run quality control operation
Calibration Scaling operations for instrument’s parameters
Setup Set system parameters
Statistics Workload statistics analysis
Service Maintain and test the equipment
19
Log Check the instrument operation and fault information

Help Operation help
About Check the instrument version information
logout Change user login
2. Data Edit Area

Display name, age, sex, blood type and other details of samples. The
operator can switch input methods to input sample information by pressing "Ctrl
+ Shift".
3. Shortcut Key Area

Table 3-3 Shortcut Key Button
Shortcut Key Function
Next serial number Input next ID number
Can do the blood routine examination,
Mode reticulocyte, whole blood and pre-dilution
switching operation
Transmit the test data to other computer systems
Transfer
manually, such as the LIS system
Print Print the test result
Print Preview
4. System Time
Display current date and time.
5. Counting Results Display Area
Display test results, parameter units, reference range, alarms, scatter plot, 3D
map and other results information.
3.5 Reagent, Control and Calibrator

The reagent is configured specifically for the NCC-51 flow systems in order
to provide optimal system performance. Each NCC-51 is checked at the factory
using the specified reagents and all performance claims were generated using
these reagents. Thus non- NeoMedica reagents may affect analyzer
performance, or result serious mistakes, even accidents. Reagents mentioned in
this Manual refer to matching reagents of the analyzer.
NOTE
 Reagents must be stored at room temperature to ensure optimal
performance. All reagents should be protected from direct sunlight,
20
undercooling and overheating during storage.

 The background test should be done after the replacement of diluent,
Detergent, sheath and detergent to ensure it is within the normal range.
 The reagent inlet tubes have a cap attached that minimizes evaporation and
contamination during shipping. The tubes can only insert reagent to right
connections. Please close the cap tightly.Ensure all reagents to be used in
validity period.
3.5.1 Diluent
Diluent is a tasteless transparent isotonic fluid, can be used for blood cells
counting and classification. It has the following functions:
(1) Dilute whole blood samples.
(2) Keep the shape of cells during test process.
(3) Clean WBC and RBC micro-aperture and tubes.
(4) Provide a conductive environment for counting
Storage and service life after opening: Keep the diluent under 5-35 C, after
opened, it can be used to the validity period on the label. Once opened
(connected to the instrument), the product shelf life is only 60 days.
3.5.2 Sheath
Sheath is used to keep the original ecology of blood cells and bleach RBC
to eliminate the scattering of laser. WBC maintains the closest cell structure to its
original state. Basophil structure occur minor changes for the water-soluble
property of basophilic granule. RBC osmotic pressure is higher than sheath, so
RBC is changed by sheath. The hemoglobin of RBC diffuses from the cells, and
moisture content of sheath diffuses into cells. Although the cell membrane
remains good, but the RBC and sheath have the same refractive index, and it
showed under the laser virtually.
Storage and service life after opening: Keep the sheath under 5-35 C, after
3.5.3 Detergent
Detergent which contents activity protease can be used to clean the tubes,
WOC/HGB cups, RBC cups and flow system.
Storage and service life after opening: Keep the Detergent under 5-35 C,
after opened, it can be used to the validity period on the label. Once opened
21
3.5.4 Probe Detergent

Detergent contains the active enzyme to clean the agglomerated protein in
the WBC, RBC probes and measurement devices.
3.5.5 Lyse
Lyse which doesn’t contain the azide and cyanide is a new reagent. It meets
the following test requirements.
(1) Dissolve RBC instantly with minimum ground substance complex.

(2) Transform the membrane of the WBC to diffuse the cytoplasm. At the
same time, the membrane will shrink centre on nucleus. As a result, WBC is
present in granular shape.
(3) Transform the hemoglobin to the hemo-compound which is suitable for
the measurement in the condition of 540nm wavelength.
(4) Avoid the serious pollution to human body and environment that caused
by cyanide.
Storage and service life after opening: Keep the lyse under 5-35 C, after
CAUTION
 Detergent and probe detergent is alkali cleaning agent

(1) Prevent skin and eyes from contacting the reagent.
(2) Once contact with skin, rinse with water.
(3) Once contact with eyes, rinse with water and seek medical treatment
immediately.
(4) If ingested, induce vomiting and seek medical treatment immediately.
3.5.6 Control and Calibrator
Control and calibrator are for instrument quality testing and calibration.
Control is an industrial production of whole blood. It is a hematology
reference control used in monitoring determinations of blood cell values on
hematology analyzers. It is with low, normal and high value. Three controls must
be run every day to ensure the reliability of the results. Calibrator is also an
industrial production of whole blood. It is used for calibration. Please refer to the
instruction of control and calibrator for use and storage methods.
22
The "control" and "calibrator" mentioned in this manual refer to the special
control and calibrator assigned by NeoMedica. Users can purchase from
NeoMedica or agents designated by NeoMedica.
23
4.1 Overview
CAUTION
 Environment Requirements: Temperature: 15 C ~ 35 C; Relative

humidity: ≤ 85%;
 Place the instrument on a smooth and big enough platform which is easy
to operate. Away from direct sunlight.
 Try to use a separate AC receptacle, and install stabilized voltage supply
or UPS (Uninterruptible Power Supply). Do not share an AC receptacle with
centrifuges, room temperature shower (thermostat), refrigerators, air
conditioners or ultrasonic cleaning equipment or other equipment which
will interfere the instrument
CAUTION
 Installation of the analyzer by an unauthorized or untrained person could

result in personal injury which is exclusive of the warranty. Never attempt
to install and operate the analyzer without a NeoMedica authorized
representative.
This instrument has been tested strictly before delivery. It should be

carefully packed before transport in order to avoid being damaged. Check
the package carefully to see whether there is a physical damage when arrive.
If damaged, please immediately contact the after-sale service department of
NeoMedica or local agent.
4.2 Unpacking and Inspection

Take out the analyzer and accessories from shipping carton carefully,
keep the packing material for future transport or storage. Check as the
following:
(1) Quantity of accessories according to the packing list.
(2) Leakage or soakage.
(3) Mechanical damage.
(4) Bare lead, inserts and accessories.
Please contact NeoMedica Customer Support Center if any problem occurs.
24
4.3 Space Requirements

In order to ensure the proper space for operation, maintenance and
replacement of reagents, the host installation needs to meet the following
requirements:
(1) Choose a place near the power supply.
(2) Eight inches of space behind the analyzer must be left for air flow.
(3) There should be 100 cm of space above to either side of the analyzer for
service access.
(4) Sufficient space is required beneath for placing reagents, waste containers.
4.4 Power Supply Requirements

Be sure that the system is located at the desired site before attempting
any connections. See Table 4-1 for details.
Table 4-1 Power Supply Requirement
Optimal Voltage Voltage Range Frequency
AC 220V AC 100V～240V 50/60 Hz
WARNING:
 Analyzer should be used in the condition of well ground connection for
ensuring accuracy of instrument and safety of operator.
 A fluctuated voltage would impair performance and reliability of the
analyzer. Proper action such as the installation of AC manostat (not
provided by NeoMedica) should be taken before operation.
 Frequent power failure will seriously decrease the performance and
reliability of the analyzer. Proper action such as the installation of UPS (not
provided by NeoMedica) should be taken before operation.
4.5 Environment Requirements

(1) Temperature: 15～35C (Optimum temperature is 25 C)
(2) Relative humidity: ≤ 85%
(3) Recommend to install heating and cooling air conditioning
(4) Avoid using the instrument at extremely high or low temperature.
(5) Away from direct sunlight.
(6) Choose a well-ventilated place.
(7) Away from communication equipment which may interfere the instrument
by producing high frequency electric wave.
25
4.7.2 Tubing Installation

There are five tube-connectors on the left panel: DETERGENT, DILUENT,
DETERGENT, SHEATH and WASTE, each of which is wrapped with a cap to
avoid contamination by the NeoMedica before shipment. Uncover and set the
caps aside carefully for further use on initial installation.
NOTE
 After installation, all tubes should be in a nature relaxed state and without
distortion.
 Using tools for tubing installation is prohibitive. Only installing by hand is
allowed.
 The reagent bottle cannot be used if there is damage, leakage, expiration
and other anomalies. Please contact with local suppliers or after-sale
service department of NeoMedica directly.
 To ensure safety and take optimal system performance into account,
NeoMedica recommend that all reagents should be placed on the same
base and lower than analyzer position.
1. DILUENT Tubing Installation
Remove the diluent tube with blue faucet from reagent kit and attach it to
DILUENT connector on the left panel. Place the other end into the diluent
container. Twist the cap until secure.
2. DETERGENT Tubing Installation

Remove the Detergent tube with red faucet from reagent kit and attach it
to DETERGENT connector on the left panel, place the other end into the
Detergent container. Twist the cap until secure.
3. SHEATH Tubing Installation

Remove the sheath tube with black faucet from reagent kit and attach it to
SHEATH connector on the left panel. Place the other end into the sheath
container. Twist the cap until secure.
4. WASTE Tubing Installation

Remove the waste tube with white faucet from reagent kit and attach it to
WASTE connector on the left panel, connect BNC plug to the socket marked
“SENSOR” on the rear panel. Twist the tube’s cap clockwise onto the waste
container until secure. Place the waster container on the level at least 50cm
lower than the analyzer.
5. LYSE Tubing Installation

Remove the lyse tube with white faucet from reagent kit and attach it to
LYSE connector on the left panel. Place the other end into the lyse container.
Twist the cap until secure.
27
4.7.3 Printer Installation

Following these steps to install the printer:
1. Place the printer in an appropriate location adjacent to the instrument so as
to operate easily;
2. Take out the printer from transport package.
3. Check the printer, if being damaged, please contact supplier;
4. Check the printer power;
5. Assembly the printer according to printer manual;
6. Connect the power cord to the printer,and grounding plug;
7. Confirm that the printer and computer are properly connected;
8. Install the ink cartridges and paper according to the instructions; ensure the
printer is adjusted to the correct receiver size;
9. Connect the power cord to a grounded outlet and turn the power on.
4.8 Transport and Storage Requirement

When the instrument is without using for a long time or before
transportation, please run the "Prepare Shipping" procedure. Please refer to
Chapter 10 "Maintenance and Care" for details. Proceed as follows:
1. Select "Non-use Packing" on the "Maintenance" interface;

2. Follow the prompts to unplug the relevant tubing connectors and keep the
waste interface;
3. Instrument starts emptying operation, and the progress bar is on the bottom
of the screen.
4. After emptying, back to maintenance interface.
NOTE
 Storage temperature: -20 C ~ 55 C;.
 Relative Humidity: ≤ 95%;.
 Atmospheric pressure: 50kPa-106kPa
 Before delivery, external disinfection is needed.
28
Chapter 5 Principles of Operation
5.1 Overview
NCC-51 uses electrical impedance method (also known as Coulter
principle) to detect the amount and volume distribution ofred blood cells and
platelets. The colorimetric method is for determining the content of hemoglobin.
The 4-angle laser scattered method is for the five part differential of white
blood cells. Three separated channels are used for getting the blood cells
counting results respectively.
(1) WBC and five part differential data of sheath are detected by laser.
(2) HGB is detected by colorimetric methods in WOC/HGB counting chamber.
(3) The data of RBC and PLT are detected by electrical impedance methods in
RBC counting chamber.
In each counting process, the instrument will aspirate, dilute and mix the
samples and then measure each parameter.
5.2 Sample Aspiration

NCC-51 supports two modes of cell blood counting analysis:
(1)Whole blood open type sampling mode
(2)Pre-dilution Sampling mode
The aspiration volumes are:

Whole blood open type sampling mode 20µL
Pre-dilution Sampling mode 20µL
The whole blood sample is aspirated into the analyzer by the precision
stepper motor and distributed into different measuring channels by shear
valve.
5.3 Sample Dilution

The sample is divided into two parts after being aspirated. These two parts
samples will inflood into the WOC/HGB cup and RBC pre-mixing cup
respectively, after react with different reagents will aspirate into optical WOC
flow cell and RBC cup to get the results of white blood cell counting /
hemoglobin measurement, red blood cell / platelet counting and WBC five
differential.
According to the different needs of the operators, the instrument provides
two operating modes: Whole blood open type sampling mode and Pre-dilution
Sampling mode
29
5.4 WBC Test Principle
5.4.1 Four-Angle Laser Light Scatter Technology
Figure 5-1 WOC Flow Cell
The whole blood samples are diluted with an appropriate proportion of

sheath; white blood cell remains its original state approximately. Using flow
cytometry to make the cells in a single arrangement flow. The scattering
density can be measured through the laser beam detection zone.
(1) 00: Forward Angle Light Scatter (10～30), which can be used to measure
cell size;
(2) 100: Narrow-Angle Light Scatter (70～110), which can be used to measure
cell complexity and structure.
(3) 900: Ninety-Degree Light Scatter (700～1100), which is mainly used to
measure the cell surface and internal structure.
(4) 900 D: Ninety-Degree Depolarized Light Scatter (700～1100), which can be
used to measure certain type of cell granularity .
32
Figure 5-2 Multi-Angle Laser Scatter Optical Bench

Light source is a vertical direction semiconductor laser with wavelength of
639±10nm and power is 10mw. Laser beam goes through a cylindrical lens
which can change the shape of beam spot from circle to oval. Then the beam
goes through a 125um cutting slit which can prevent low light passing through.
Finally, it is shaped into a spot with a 80um-wide cell through an imaging lens
and focus on the white cell in the quartz sheath flow.
The laser beam is small in the horizontal direction, so the cells do not
scatter laser much. If the remaining horizontal light reaches the 0° detector,
blocker can block it to prevent electronics saturation. The horizontal forward
angle light directly scatters to the punch hole through the convergent lens. The
light of 0 degree pass through the hole to the silicon photodiode detective unit of
0 degree.10 degrees scattering light reaches to the 10 degrees silicon
photodiode detection unit by reflector.
Vertical scattered light is collected by the condenser lens group, and then go
through a 700um cutting opening (filter stray light and improve accuracy). After
the scattered light which contains cell information passing through the
condenser lens group, the vertical scattered light will be divided into two parts
by a beam splitter mirror. A part of light directly scatters to the 90 degrees
photomultiplier tube. The remaining scattered light will go through the line
polarizer, and only the depolarizing scattered light can reach 90 degrees
depolarizing photomultiplier tube
33
Figure 5-3 Optical Detection System
1--- System Work Platform

2---Laser
3---Laser Bracket
4---Reflector Plate
5--- Cylindrical Mirror
6---125 Microns Slit and Bracket
7---Imaging Lens Group and Bracket
8---WOC Flow Cell
9---Forward Condenser Group and Bracket
10---PhotoAmp BOARD PCBA
11---Side Condenser Group and Fine-tuning Mechanism
12---700 Microns Slit and Bracket
13---Spectroscope and polarizer Bracket
14---High voltage circuit board
15---314 PMT
16---131 PMT
34
Figure 5-4 Scatter Plot Principle
The gray area on left scatter plot is the ghost cells. It reflects that RBC
dissolve into pieces on the scatter plot; green is for lymphocyte group; pink is
for monocyte group; blue is for neutrophil; white is for basophil group; red is for
eosinophil group.
Figure 5-5 Three-dimensional Plot

Figure 5-5 is a three-dimensional plot of WBC (3D). It can be magnified to
view WBC differential and change S0, S10, S90 relative positions according to
clinical experience.
5.4.2 White Blood Cell Differential

NCC-51 does the four-angle scatter analysis for the cells which go
through the WOC flow cell. White blood cells are being divided into 5 parts:
basophil, eosinophil, monocyte, neutrophil and lymphocyte. The default unit of
cells number is 109/L.
 White Blood Cell Number

The total number of white blood cells is obtained by four-angle laser light
35
scatter technology.
 Lymphocyte Number (Lym#)
 Lymphocyte Percent
Lym% = Lym#/WBC
 Monocyte Number (Mon#)
 Monocyte Percent
Mon% = Mon# /WBC
 Neutrophil Number (Neu#)
 Neutrophil Percent
Neu%=Neu#/WBC
 Eosinophil Number (Eos#)
 Eosinophil Percent
Eos%=Eos#/WBC
 Basophil Number( Bas#)
 Basophil Percent
Bas%=Bas#/WBC
5.5 Hemoglobin Concentration Test Principle
5.5.1 Colorimetry Principle

Add sheath into the diluted sample in WOC/HGB counting chamber. Red
blood cells will dissolve and release hemoglobin. Then the hemoglobin
combines with Detergent to form hemoglobin mixture. Use LED light-emitting
diode to illuminate the hemoglobin mixture by the monochromatic light of
540nm wavelength at one end of the WBC counting chamber. At the other end
using the optical tube to receive the transmitted light and then amplify the light
intensity signal to voltage signal. Compare it with the voltage generated by the
transmission light intensity before adding the sample into the colorimetry
chamber (only with diluent) to get the value of hemoglobin concentration.
Hemoglobin concentration is proportional to the absorbance of samples of
540nm wavelength. The process of measurement and calculation is done
automatically by the analyzer, and the results will be displayed in the analysis
results area.
5.5.2 HGB Parameter

Hemoglobin concentration (HGB) is calculated by the following formula:
36
E 
HGB  K  Ln B  ；
 ES 
Ln is a natural logarithm.
K is a constant.
EB is the luminous intensity of light pass through the background.
ES is the luminous intensity of light pass through the samples.
5.6 Red Blood Cell /Platelet Test Principle
5.6.1 Electrical Impedance Principle

The analyzer uses the traditional electrical impedance for the blood cells
testing and counting. See Figure 5-6, conductive liquid (mainly diluent)
provides constant current source for electrode to help the circuit form a stable
impedance loop. When the cells pass through the pores, the conductive liquid
is substituted by cells, and the resistance of loop changes to produce electrical
pulses. When different volumes of cells pass through the pore there will have
different electrical pulses amplitude. So we can determine the number and size
of cells according to the number and amplitude of electrical pulses.
Figure 5-6 Electrical Impedance

As the number of pulses corresponds to the number of cells pass through
the pores, the pulse amplitude corresponds to the volume of the cells, so the
analyzer can count and classify the cells according to size of the cells. The
analyzer automatically divides the cells into red blood cells, white blood cells,
platelets and other groups in accordance with pre-set volume classification
procedure.
37
5.6.2 Volumetric Metering
Figure 5-7 Volumetric Metering

The analyzer controls the quantity of samples that pass through the pore
during counting by volumetric metering unit to obtain the exact counting results
of blood cells in quantitative samples. The volumetric metering unit includes
volumetric metering tube and two photodetectors. As shown in Figure 5-7,
empty the volumetric metering tube before counting. When the sample flows
through the pore, the liquid level of volumetric metering tube will decline slowly.
When the liquid level passes through the start detector, it will produce an
electrical signal and then the analyzer starts counting; when the liquid level
reaches the stop detector, it also will generate an electrical signal and then
finish counting. If there are bubbles or other abnormal stream in the flow
system during the process, "bubble" or "clog" alarm will be shown. Please refer
to chapter 11 Troubleshooting for handling.
5.6.3 Red Blood Cell Parameters

 RBC Number
The instrument gets the number of red blood cell (RBC) by measuring the
corresponding electrical pulse numbers of RBC directly. The unit is 1012/L.
RBC = n ×1012 / L
38
 MCV
The mean corpuscular volume (MCV) is the average volume of individual red
blood cells. The MCV is derived from the RBC size distribution data. The unit is
fL.
 HCT
The hematocrit (HCT) is the ratio of red blood cells to plasma. It is expressed
as a percentage of the whole blood volume. The HCT is calculated from the
RBC count and the MCV as follows:
 MCH
The mean corpuscular hemoglobin (MCH) is the average amount of
hemoglobin in the red blood cell and being expressed in picograms. The MCH
is calculated from the RBC and the HGB as follows:
 MCHC
The mean corpuscular hemoglobin concentration (MCHC) is the ratio of the
weight of hemoglobin to the volume of the average red blood cell. It is
expressed in percent and calculated from the HGB and the HCT as follows:
 RDW-CV
The RDW-CV is derived from the RBC histogram and being expressed in
percent.
 RDW-SD
The RDW-SD is the width of 20% peak value of red blood cell distribution
histogram .The unit is fL.
39
5.6.4 Platelet Parameters

 PLT Number
The instrument gets the number of platelet (PLT) by measuring the
corresponding electrical pulses of RBC directly. The unit is 109/L.
PLT = n ×109 / L
 MPV
The mean platelet volume (MPV) is derived from the PLT histogram after the
PLT count has been determined. The unit is fL.
 PDW
The platelet distribution width (PDW) is a measure of the heterogeneity of the
PLT population. It is expressed as the geometric standard deviation. (10 GSD).
 PCT
The PLT is calculated as follows:
Remark: The unit of PLT is 109/L. The unit of MPV is fL
40
Chapter 6 Settings
6.1 Overview
Initialization setting of NCC-51 has been done before delivery. Setting of
the interface at the first boot is default. To meet the different needs, some
parameters can be re-set.
6.2 Time Setting

There are three formats of date: YYYY-MM-DD, MM-DD-YYYY, and
DD-MM-YYYY. Y indicates Year, M indicates Month, D indicates Day. If time
setting is changed, the time on screen and printed output will also change.
1. Entering into Setting

Click "Time" button on the "Setup" interface, and then enter into the
interface as Figure 6-1.
Figure 6-1 Time Setting
41
Chapter 6 Settings
2. Select Format
There are three formats of date: YYYY-MM-DD, MM-DD-YYYY, and
DD-MM-YYYY. Click the button to select the format needed.
3. Whether to use 24-hour format

If you want to use the 24 hour format, just need to tick in front of the small
box.
4. Save and Exit

Modify the date and time, then click the "Save" bottom in the right corner of the
interface shown in Figure 6-2. Click “Yes" to save the results; click "No" to exit.
Figure 6-2 save settings
6.3 System Maintenance

Instrument maintenance operation, alarm, language, etc., can be set in the
interface shown in Figure 6-3.
Figure 6-3 System Setting interface
42
Chapter 6 Settings
1. Auto Clean Setting

Please click “Maintenance-General” menu after you enter the "Setup"
interface, and then from the drop-down "Auto clean" button to select "times",
it is recommended that the flow system should be cleaned once for each 60
counting. See Figure 6-4.
Figure 6-4 Auto Clean Setting
43
Chapter 6 Settings
2. Alarm setting
Please click "Alarm" menu after you enter the " Setup " interface, and then
from the drop-down "General" button to choose whether to open the alarm and
waste alarm, it is recommended that the operator should open the alarm and
waste liquid alarm prompt. See Figure 6-5.
Figure 6-5 Alarm setting
44
Chapter 6 Settings
3. Auto Blank Setting

Please click "Maintenance" menu after you enter into the "Setup" interface,
and then tick the “Auto blank” in front of the small box . It is recommended to
select "on" in "Auto Blank” so that after each boot, the instrument can
automatically enter into counting interface and run background tests to check
whether the instrument is normal. See Figure 6-6.
Figure 6-6 Auto Blank Setting
4. Counting Time Setting

Enter into the "Setup" interface and then click " Counting time” menu. Set
the upper and lower limits of WBC and RBC counting time warning as shown
in Figure 6-7.The upper limit of RBC is 11 seconds. If the counting time is more
than this value, "Clog" will be alarmed. The lower limit of it is 9 seconds. If the
counting time is less than this value, "Bubble" will be alarmed. The upper and
lower limits of WBC are similar to those of RBC.
NOTE
 The upper and lower limits are set before delivery. Generally, they should
not be modified so as to avoid false alarm.
45
Chapter 6 Settings
Figure 6-7 Counting time setting
46
Chapter 6 Settings
6.4 Dictionary Maintenance

If the name of the same department or doctor needs to be inputted
repeatedly in the "Counting" and "Query" interface, the operator can set up a
simple code. When editing patient’s information, the operator only needs to
input the code and press "Enter" button, then the corresponding department or
doctor’s name will be displayed.
1. Entering into Dictionary Maintenance

Enter into "Setup" interface and click "Dictionary Maintenance", and then
the default interface will be displayed as Figure 6-8.
2. Department Code Setting
Click "Add", input the name of department in name box, such as "internal
medicine" and then input “1" in code column. If the operator wants to input
"internal medicine" next time, he only needs to input "1" then press "Enter".
Click "Delete" button to delete the code item established.
Click "Modify" button to modify the code item established.
Figure6-8 Department Setting
47
Chapter 6 Settings
3. Doctor Code Setting

Click "Sender" menu. Operator can establish a relationship between the code
and doctors' name to save input time.
Click "Add", and then input doctor's name in name box, such as "LiQiang" and
“002" in code column. Once the operator wants to input "LiQiang" next time, he
only needs to input "002" then press "Enter". See Figure 6-9.
Click "Delete" button to delete the code item established.
Click "Modify" button to modify the code item established.
Figure 6-9 Doctor Setting
6.5 Display Setting

Select the languages of parameters according to the unit of some
parameters which need to be modified.
1. Entering into Display Setting
Click "Display" after entering into "Setting" interface as shown in Figure
6-10.
48
Chapter 6 Settings
Figure 6-10 Display Modification Interface

2. Display Modification Setting
The operator can select different parameters units, Chinese and English
parameter language and reference value order etc. Click the
"Display--General" button to select the desired display settings, the results on
screen and those printed out will also change.
3. Save and Exit
Click SAVE, the save dialog box will display (see figure 6-11). Select Save
to save the modification of display settings and back to the corresponding
interface, and Cancel is contrary.
Figure 6-11 save dialog box
6.6 Print Setting

User can choose "Printer Type", "Print Format" and "Auto Print" according
to the specific circumstances, and input the corresponding hospital name to
the “Printer Title”.
1. Entering into Print Setting
49
Chapter 6 Settings
Click “Print” in the Setup interface and enter the Print Setting interface.
(See figure 6-12).
Figure 6-12 Print Setting
2. Setting Print Options

In Print Setting, operator can select printer type, print format, auto print
and input hospital name in “print title”.
3. Save and Exit
to save the print settings and back to the corresponding interface, and Cancel
is contrary.
Figure 6-13 save dialog box
50
Chapter 6 Settings
6.7 Transfer Setting

In Transfer Setting, operator can set the port number, IP, baud rate, data
bit, stop bit and parity bit of the external communication port.
1. Entering into Transfer Setting
Select Transmit in the Setup interface, then enter the Transfer Setting
interface (see figure 6-14)
Figure 6-14 Transfer Setting Interface
2. Modify Transport Protocols

Operator can modify the port number, IP, baud rate, data bit, stop bit and
parity bit of the communication port. If the auto-trans are “ON”, the test results
will transmit from the communication port automatically.
CAUTION
 Transfer setting is already set before delivery. As a rule, there is no need to
reset, or the data transmission will be affected. Necessary modification
should be done under the guidance of NeoMedica engineer.
3. Save and Exit
to save the modification of transfer settings and back to the corresponding
interface, and Cancel is contrary.
51
Chapter 6 Settings
Figure 6-15 save setting

NOTE
 Click SAVE and select Save to save the settings after modification,
otherwise it will lose.
6.8 Group Parameters

To monitor abnormal test parameters of blood samples, it is essential for
the operator to set normal ranges of the parameters according to laboratorial
or clinical requirement. Information or indication will be given if the test values
exceed the range. The analyzer provides the limit of 24 parameters, any
results exceeding the range will be marked H (High) or L (Low). H means the
results are higher than the upper limits, while L means the results are lower
than the lower limits.
CAUTION
 The shift in parameter limit may cause changes in abnormal indication of
hematology index. Please confirm the necessity for changing.
6.8.1 Limit Review

At Limit setting interface, operator can input proper parameter limits or use
the default limits. Default limits are different depending on the patient group.
Figure 6-16 depicts the General group limits, and figure 6-17 depicts the User1
group limits.
52
Chapter 6 Settings
Figure 6-16 Limit Setting
Figure 6-17 Limit Setting
53
Chapter 6 Settings
6.8.2 Limit Modification

Operate as follows to modify the parameter limit:
1. Click the triangle on the right side of Group to select the group that needs
to be modified.
2. Select the lower or upper limit of parameters need modification. Move the
cursor into edit box, press “Backspace” on the keyboard to delete raw data
and input the new lower or upper limit.
3. Click SAVE, the save dialog box will display (see figure 6-20). Select NO to
cancel and go back to browsing status of parameters Select YES to save
the modification and back to the corresponding interface.
6.9 User Management

Operator should login the system with identity to operate the routine check.
Only the administrator can modify user setting, so message erection of the
operator is necessary.
1. Entering User Management Setting
Click User in the Setup interface, then enter user management interface. (See
figure 6-19).
Figure 6-19 User ManagementAdd User
54
Chapter 6 Settings
Input the user’s name, select Permission, set password (default password
is null) and click “Add” to add the new user. (See figure 6-20).
Figure 6-20 Add User

2. Modify User
Click the user and choose “Modify” to modify the User name, group and
password.
3. Delete User
Select and click Del. to delete the user. Then select OK or Cancel to
confirm whether to delete the user or not. (See figure 6-21).
Figure 6-21 delete user
6.10 Permission
In order to guarantee the proper use, it is necessary for the administrator
to only give partial permissions to other operators, such as only allow
55
Chapter 6 Settings
operators to query and count data, but cannot delete.

Select certain permissions in the picture below. (See figure 6-22).
Figure 6-22 Permission Setting
56
Chapter 7 Daily Operation
Figure 7-1 Blood Cell Count interface
After startup, background counting should be performed before blood

sample test. Analyzer can be set to run background counting automatically
after startup. Consult Chapter 6 for the instrument settings. The range of
background is listed in Table 7-1.
Table 7-1 Range of background
Parameter Acceptable range
WBC ≤0.20x109/L
RBC ≤0.02x1012/L
HGB ≤1g/L
PLT ≤10.0x109/L
If the background result is out of this range, repeat the above procedures until
it is in this range. If the results are still out of this range after repeat five times,
please refer to please refer to 11.4.2 for Troubleshooting for help.
7.4 Quality Control

Quality Control should be performed before daily test to ensure accuracy of the
results. Please refer to Chapter 8 Quality Control.
59
7.5.1 Whole blood collection

Collect whole blood sample through vein-puncture and store it in a clean
sample tube with EDTA-K2·2H2O, which can keep the configuration of WBC,
RBC and avoid platelets aggregation. Gently shake the tube 5~10 times and
ensure mix well.
The following anticoagulants are commonly used in whole blood collection:
1. Heparin:
Lead to cell aggregation and change the cytoplasm’s color of
Romanowsky staining. The concentration of high heparin > 7.5UL/
capillary will lead to increase in HCT and MCV.
2. Sodium citrate:
Since sodium citrate is liquid, it may be diluted to 10/11 of the original in
the tube filled with whole blood. This anticoagulant is used for agglutination
when a suspect EDTA causes spurious thrombocytopenia.
3. ACD and CPDA:
Most widely used in cell Concentration (especially platelet concentrates),
usually not used for cell counts.
4. EDTA:
In the salt of EDTA, use EDTA K2（United States and Japan）and EDTA K3
（United States and Europe）,sometimes NA2EDTA. And EDTA K2,
EDTA K3 which recommend by ISCH in1993 are most widely used in the
blood test of the world. But other EDTA salts can also be used. EDTA
could lead to Pseudo-thrombocytopenia through Platelet aggregation.
(Incidence is about 1/800)
5. Fluoride:
Use before EDTA. Without side effects according to the survey
7.5.2 Pre-dilution sample preparation

Pre-dilution sample preparation procedures as follow:
1． Set the current test mode to Dilution mode under the “Count” interface, as
shown in figure 7-2:
Figure7-2 Mode Switch operations
2． In the process of whole blood switch to dilution mode, the instrument will
be cleaned.
61
3． Take a clean test tube under the aspiration probe. And then press the
drainage button under the counting interface to discharge 150uL diluent
along the tube wall into the test tube, in order to avoid produce bubbles or
spills.
4． Please quickly inject collected 20uL peripheral blood into the test tube and
blending with the diluent.
CAUTION
 The collected diluent should avoid mixed with dust, otherwise it will
produce analytical error.
 Peripheral blood and diluent after full reaction, should be placed for 3
minutes, and then only after blending again that can do the analyze.
 Ensure that the sample has been analyzed within 30 minutes after dilution;
otherwise the analysis results are not reliable.
 The sample placed after a period of time should be blending to anew for
analysis.
 Each laboratory should according to their respective sample number,
sampling method and the technical level to evaluate the stability of the
results under the pre-dilution mode.
7.5.3 Sample stability

Better to use fresh whole blood. ICSH (International Committee for
Standardization of Hematology) defined fresh blood as: samples processed
within 4 hours after collecting. When whole blood samples are thoroughly
mixed, placed in EDTA-tubes, and tested within 8 hours after collecting, the
accuracy of each parameter will be highest. Test samples within 5 to
20minutes or over 8 hours, the WBC volume distribution will offset.
7.6 Information Input

Click Data in the interface to input the detail information about the sample,
and NeoMedica recommends operator to input the detail information before
sample analysis. (See figure 7-3
62
Figure7-3 Data Input 1
Figure7-3 Data Input 2
63
Click “Ctrl+Shift” on the keyboard to select Input Method.

Name: Input Chinese characters, letters and numbers.
Sex: Select male or female. If not, default as blank.
Age: Select Year, Month and Day.
Blood Type: Select A, B, O, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-.
O Rh+, O Rh-. If not selected, default as blank.
Group: Select Auto, Man, Woman, Child, New-born, General, Custom 1,
Custom 2, Custom3.
If Auto is selected, the reference values are listed as Table 7-2.
Table 7-2 Reference Value
Reference Value Age(Year) Sex
General NO input Blank, M,F
General ≥16 Blank
Man ≥16 M
Woman ≥16 F
Child >1 and ＜16 Blank, M,F
Baby <1 Blank, M,F
ID: The ID number is in range from 00000000 to 99999999. If no ID input, the

ID of current sample will be automatically added follow the last one.
Case ID: Input the sample number.
Bed No.: Input bed No. of patient.
Department: Input department name or code of operator.
Checker: Input checker’s name or code.
Sender: Input sender’s name or code.
Assessor: Input assessor’s name or code.
NOTE
 The ID number is set to 0 only under Background Count. The blood
sample ID CAN NOT be 0.
CAUTION
 Each sample has a corresponding identification number. Do not confuse.
7.7 Sample Counting
7.7.1 Mode
Under the "count" interface, click the "▽" button shown below, select the
desired operating mode.
64
Figure 7-4 Mode Switch

After selected the required working mode, click on "ok" to switch into the
corresponding work mode.
NOTE:
 User can choose CBC if he wants whole blood and pre-dilution modes.
CBC mode is only available for counting and without differentials. The
counting result includes 18 parameters and the diagrams of RBC and PLT.
 “CBC+5Diff+RRBC"--- For counting after dissolving the indissolvable red
blood cells. It is suggested that when RRBC? alarms, switch counting
mode to CBC+5Diff+RRBC, and then run counting again so as to eliminate
the interference of white blood cell coning from the indissolvable red blood
cells. If WBC total number is far less than that of the first counting, it shows
that this specimen contains indissolvable red blood cells.
7.7.2 Counting and Analysis
WARNING
 The sharp sample needle contains residues of clinical specimens, controls
or calibrators probably have potential infectivity. Do not directly contact the
sample probe.
NOTE
 Do not reuse disposables.
 Ensure the inputted ID number correspond with the sample.
CAUTION
 Do not open the front panel after start counting.
7.8 Data Query and Output

After each counting, the results are automatically saved in a database that
could store at least 200,000 results include 34 parameters (2 scatter diagrams,
2 histograms, 2 Three-dimensional plots).Operator could review all of the
results, scatter diagrams and histograms that store in the database through
query and statistic.
65
7.8.1 Data Query

Click “Data”-“Query” at the “Count” interface, and then enter
the query interface. (See figure 7-5)
Figure 7-5 Data Query

The operator can quickly query the results of specimens according to the
query condition such as date, ID, name, sex, age, blood type etc. (Combined
Query is available).Take ID as an example, to query the results between ID
1000 and ID 1002, click the box in the left of ID and input 1000 to 1002, click
Query, the needed results will be displayed. (See Figure 7-6)
66
Figure 7-6 Condition Query
67
7.8.2 Data Selection

Click the result needed, the row of result will be highlighted to identify
being selected. Figure 7-7 is the sample record of number 1040.
Figure 7-7 Select Single Result
68
Select single data (such as No.1040), click “Detail” (or double-click

directly), then the detail information of the datum will be displayed.
Figure 7-8 Query Detail Information
69
Press and hold the "Ctrl" or "Shift" to select the desired data, the selected
data will show highlight blue, as shown in figure 7-9
Figure 7-9 select multiple data
70
7.8.3 Data Deletion

After processing plenty of samples, it is necessary to clean up or delete
the mass data stored in the analyzer according to the requirement of the
operator.
NOTE
 Be aware that once the data are deleted, they can NOT be recovered.
Please operate with caution.
7.8.4 Repeatability
Check the precision of each parameter of selected sample result,
including Mean, SD and CV%. The calculation formulas are as follows:
N is the number of samples selected, Xi is the results of i times for the

specified parameters.
Selected the results that need to be calculated CV, click Prec. into the
interface as figure 7-10, and check the precision.
71
Figure7-10 Repeatability computing interfaces
NOTE
 Only can compute the repeatability of 10 specimens.
 “***”means invalid. If some parameters of selected sample are invalid, the
precision is invalid too.
7.8.5 Data Comparison

The operator can view the selected sample data contrast diagram, after
you choose the sample results, click “Compare” button to enter the “Data
Comparison Interface”, to view the results of the selected sample data
comparison, as shown in figure 7-11.
72
Figure7-13 Data Comparison Interface
7.9 Reticulocyte Analysis

The reticulocyte package software enables the operator of the NCC-51
system to analyze a whole blood specimen for reticulocytes. The reticulocyte
specimen is prepared by using reticulocyte reagent to produce a diluted,
stained sample.
Press Retc to start reticulocyte analysis. The analysis screen is shown
below.
73
Figure 7-12 Reticulocyte Analysis

The prepared specimen run with the reticulocyte package on the NCC-51
system will measure results as a reticulocyte percentage. The reticulocyte
absolute number is automatically calculated when the RBC value is made
available from the Standard Hematology Data Log or entered by the operator.
The Immature Reticulocyte Fraction (IRF) is calculated from the
Reticulocyte % and displayed below the Reticulocyte absolute number.
7.9.1 Principles of Operation

Reticulocytes are defined by the National Committee for Clinical
Laboratory Standards (NCCLS) as transitional red cells, between nucleated
red cells and the so-called mature erythrocytes. In contrast to mature RBCs,
reticulocytes contain ribosomal RNA. This RNA can be seen with certain
supravital, cationic dyes that simultaneously stain and precipitate the polyanion
to form a network or reticulum. The NCC-51 system reticulocyte method uses
the thiazine dye New Methylene Blue N. The reticulocyte assay is performed in
the WOC channel of the instrument. Sample preparation is performed
manually by diluting 20 μl of blood into a tube of NeoMedica Reticulocyte
Reagent. At room temperature, staining of reticulum is complete within
approximately 15 minutes. The stained sample is aspirated in the Open Mode.
After the stained sample is aspirated, it is diluted approximately 50-fold with
74
Sheath Reagent. Once diluted with Sheath, the RBCs sphere due to the
influence of the nonionic detergent incorporated into the staining solution.
Sphering is necessary to eliminate optical orientational noise that would
otherwise be introduced into the scatter measurements. The usual lytic action
of the Sheath is prevented by electrolytes contained in the staining solution
and the lack of the usual incubation period used in this channel during WBC
analysis. In addition, the high New Methylene Blue concentration in the
staining reagent exerts a stabilizing effect on RBCs.
During data acquisition, 10 degree and 90 degree scatter are collected for
up to 30,000 events. The 0 degree threshold is set high enough to exclude
most platelets. Histogram data are used to differentiate reticulocytes, mature
RBCs, platelet clumps, and nucleated cells. Reticulocytes have 10 degree
scatter that are similar to the scatter for mature RBCs, but differ from them by
exhibiting greater 90 degree scatter. Reticulocytes are reported in percent. The
instrument will automatically calculate the reticulocyte Absolute value if an
RBC count is entered. The RBC value may be obtained from the Standard
Hematology Data Log, or it may be entered by the operator directly on screen.
Immature reticulocytes contain more RNA and absorb more stain than
mature reticulocytes; therefore, they exhibit greater 90 degree scatter. On the
NCC-51, immature reticulocytes are classified as the population of
reticulocytes that exceed a predetermined scatter threshold. Consequently, it
is possible to determine the Immature Reticulocyte Fraction (IRF) from the
scatter measurements.
The IRF was initially designated as the Reticulocyte Maturation Index

(RMI), and defined by NCCLS H44-A1 as a quantitative expression of the
relative maturation of the reticulocytes in the observed reticulum in New
Methylene blue-stained preparations. However, these quantitative visual
measurements of reticulocyte maturation have been little used due to the
subjectivity and imprecision of the manual analysis. Since automated
reticulocyte methods allow the enumeration of immature reticulocytes as a
subfraction of the total reticulocyte population, the preferred nomenclature is
Immature Reticulocyte Fraction (IRF). The immature reticulocytes are then
reported as a fraction (or percent) of the reticulocytes.
The clinical utility of the IRF is widely recognized as follows:

 Monitor hemopoietic regeneration after bone marrow transplant,
hemopoietic stem cell transplantation, or intensive chemotherapy
 Monitor bone marrow toxic insults from drugs (for example, AZT)
 Monitor erythropoietin therapy in renal failure, AIDS, infants,
myelodysplastic syndromes, and blood donations
 Classify anemia
75
 Monitor efficacy of anemia therapy (Fe, B12, Folate)
7.9.2 Reticulocyte Sample Preparation
CAUTION
 Add 20uL blood samples to be tested to reticulocyte dye test tube (3.7 mL),
and place it at about 15 ° C ~ 30 ° C for 15 to 30 minutes after mixing.
 The accuracy of the results will be affected more than 2 hours.
NOTE
 Avoid contacting with skin and clothing when using the reticulocyte reagent,
since it contains new methylene blue which will contaminate skin, clothing
and many other surfaces.
7.9.3 Reticulocyte Test

Place the prepared reticulocyte samples into the single sampler, then the
dialog shown in Figure 7-13 will pop up. Operator inputs the serial number and
RBC value, then click Run, that the reticulocyte test begins, as shown in Figure
7-14
Figure7-13 Reticulocyte Test Screen
76
Figure 7-14 Process of Reticulocyte Test
77
7.10 Statistic
On Blood Cell Count Interface, click “ ” button, and then choose

“Statistics” to enter statistics interface (See Figure 7-15). Operation procedure
is as follows:
Figure 7-15 Statistics interface
（1） In the box of statistic date, click to select Start Date and End Date,
then click OK.(see figure 7-16)
Figure 7-16 Select Data
（2） Select types such as Department and Sender in the Statistics Type box,
and then all items selected will be displayed in the middle list box.
78
（3） Select statistic item (or multi-select), click “Cal”, then the desired data
will be displayed in the right list.
（4） Click “ ” to return Blood Cell Count Interface.

（5） Click Print to print the statistics.
7.11 Shutoff
Shutoff procedure should be performed after finishing all the tests and
before turning off the power. Clean the counting chambers and related tubes. If
continuously use the analyzer or finishing today’s test, shutoff procedure
should be performed at least once every 24 hours.
The procedures of Shutoff as follow:
1. Click “Exit” on the main interface;
2. Pop-up close confirmation dialog;
3. Check whether the procedure of shutoff is finished, the close dialog box is
shown or not.
4. Turn off the power of the instrument and the computer.
CAUTION
 May be lead to data loss and abnormal boot, if the shutoff procedures
are not performed.
79
8.2 Quality Control Options

This analyzer provides four quality control methods, L - J quality control
mode, X - B quality control mode, X -R quality control mode and X quality
control mode.
(1) L-J QC
L-J QC (Levey-Jennings graph) is a simple and visual QC method with
which operator can draw QC value directly on graph after getting the Mean, SD
and CV. Mean, SD and CV are derived from following formulas:
(2) X-R QC
In X-R QC method, X indicates mean value, R indicates range of value. X
graph is mainly used to judge that if the mean value falls in required level. R
graph is mainly used to judge that if the range of value falls in required level.
(3) X QC
X QC is the variation of X-R QC; they have the same basic principle. The
difference is that the control dot in X graph indicates the mean value of two
values other than one value. On this foundation, it calculates the Mean, SD
and CV.
(4) X-B QC
X-B QC is a moving average method which is first promoted in 1970s’. It’s
based on the principle that, RBC count is varied due to the concentration of
dilution, human blood pathology and technical factor, but the hemoglobin
content in specific unit is hardly interfered by those preceding factors.
According to this characteristic, quality control of the samples is being done by
surveying the value of MCV, MCH, and MCHC.
81
8.3 QC Mode Selection

Click QC in main interface, pop up interface as figure 8-1:
Figure 8-1 QC Mode Select
System offers four quality control options: L-J QC, X-B QC, X-R QC and X
QC. Select the mode and click to enter corresponding interface.
8.4 L-J QC
In L-J QC, the operator could perform QC with 20 test parameters at most.
Considering the different needs, selecting partial parameters for QC is
available. 3 QC documents of high, normal and low are provided for saving.
8.4.1 L-J QC Edit

In different interfaces, click QC Edit enter corresponding edit interface. In
L-J QC interface, click L-J QC to enter edit interface. Input control lot NO.,
expiry data and level, then input desired assay and limit according to the
control instruction.(see figure 8-2)
NOTE
 The limit should not be more than 40% of assay, or the limit cannot be
saved in database.
82
Figure 8-2 L-J QC Edit Interface 1
Figure 8-2 L-J QC Edit Interface 2
Click OK after editing, the dialog box about whether to save the edit result
will display.(see figure 8-3)
83
8.4.2 L-J QC Run

In L-J QC interface click QC Run, enter the interface as figure 8-4.
Figure 8-4 L-J QC Run
84
8.4.3 L-J QC Graph Analysis

In L-J QC interface click QC Analysis, enter graph analysis interface as
figure 8-5:
Figure 8-5 L-J QC Graph Analysis
8.4.4 L-J QC Data Query

In the L-J QC interface, click QC Query, enter data query interface as
figure 8-6:
Figure 8-6 L-J QC Query Interface
85
8.5 X-B QC
X-B QC is different to others, with which the systems can only edit three
parameters: MCV, MCH, and MCHC. It is a QC without controls and a means
of monitoring instrument like controls, but they can’t substitute each other.
NOTE
 Recommend using X-B QC, when the quantity of samples is more than
100.
 X-B QC is for the use of random sample, not for classification samples.
 Observed the trend of QC result in reference range which made up by
reference, low and high limit.
8.5.1 X-B QC Edit

Before QC analysis, operator should finish the QC edit as follow:
1. In the main interface, click QC, and then click X-B to enter X-B QC
interface.(see figure 8-7)
Figure 8-7 X-B QC Interface

2. Input the assay and limit of parameters that require for quality control.
3. Input the number of required samples when calculate a dot of X-B QC. The
range of selection is 20 to 200; NeoMedica recommends the number is 20.
4. In the X-B QC interface, click “On” in the X-B Edit to open the X-B mode.
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8.5.2 X-B QC Run

When finish QC edit, click “Count” to operate quality control. The system
will automatically operate a QC calculation after analyzing, and get a dot that
correspond with each reference of X-B QC and save it in X-B QC graph and
X-B QC list.
8.5.3 X-B QC Graph Analysis

Operator can review QC results of three parameters through graphs. After
the count of group samples completed, the results of MCV, MCH and MCHC
will depict a dot on the graph. For example, the “X-B QC” is ON and “Batch
No.” is 20, then after the subsequent 20 counts, the system will calculate a X-B
QC value and a corresponding control dot which will display on the graph.
There are three graphs of MCV, MCH and MCHC. The graphs will update
at once after each QC counting. QC results are arranged in graphs according
to storage time. The latest is on the left side and its serial number is 1.
QC Graph instruction:
1、 Graph abscissa indicates QC run times, ordinate indicates QC result.
2、 Every parameter graph can display at most 31 dots.
3、 Every parameter graph’s upper transverse line means assay plus limit.
4、 Every parameter graph’s lower transverse line means assay subtract
limit.
5、 The 3 values on the left side of parameter graph mean:
a) upper limit —— assay + limit;
b) middle line —— assay;
c) lower limit —— assay - limit.
If the control dot falls in the area between upper and lower lines of the
corresponding graph, it means the dot is under control range; If not, the dot is
not under control range.(see figure 8-8)
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Figure 8-8 X-B QC Graph
8.6 X-R QC
X-R QC needs controls. If run a background QC, the system will alarm QC
result is invalid.
8.6.1 X-R QC Edit

Before QC analysis, operator should finish QC Edit as follows:
1. At main interface, click “QC”, then click “X-R QC”, enter X-R QC Edit/Run
interface. (See figure 8-9).
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Figure 8-9 QC edit/run 1
Figure 8-9 QC edit/run 2
2. Select corresponding level: low 1, low 2, low 3; normal 1, normal 2, normal

3; High 1, High 2, High 3.
3. Input lot NO., and select expiry date according to control instruction.
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8.6.2 X-R QC Run

When finishing QC Edit, place the prepared control in Emerge place, the
analyzer will automatically aspirate the controls to start analysis.
In QC interface, system displays two control results, and calculates the
mean and range automatically after finishing the second QC count.
8.6.3 X-R QC Graph Analysis

X-R QC is similar to X QC; operator can review QC results of 24
parameters through QC graphs. At X-R QC interface, click QC Analysis, enter
graph analysis interface. (See figure 8-10).
Figure 8-10 X-R QC graphs
X-R QC is different from X QC is, the dot on X-R QC Graph indicates

mean value or range of two QC results. The system cannot display low, normal
and high control graphs simultaneously in one interface, please select Level to
change.
In X-R QC interface, there are X graph and R graph. X graph displays the
mean value dot while the R graph displays the range dot.
If operator selects group 1 of low level to perform QC twice, the dot
correspond with mean will be within X graph which correspond with low value 1.
It also fits for the dots of other groups—the dot correspond with range is within
corresponding R graph.
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QC results are arranged in QC graph according to storage time, the latest

is on the left side and its serial number is 1.
X graph instruction:
3、 Every parameter graph’s middle transverse line indicates X (mean
value of QC results).
4、 Every parameter graph’s upper transverse line means X upper limit＝X
＋A×R.
5、 Every parameter graph’s lower transverse line means X lower limit＝X
－A×R.
d) upper limit —— X upper limit＝X＋A×R
e) middle line —— X
f) lower limit —— X lower limit＝X－A×R
R graph instruction:
3、 Every parameter graph’s middle transverse line indicates R (mean
value of QC result range).
4、 Every parameter graph’s upper transverse line means R upper limit＝
B×R.
5、 Every parameter graph’s lower transverse line means R lower limit＝
C×R.
g) upper limit —— R upper limit＝B×R
h) middle line —— R
i) lower limit —— R lower limit＝C×R
corresponding graph, it means the dot is under control range. If not, the dot is
not under control range.
8.6.4 X-R QC Data Query

When finish QC count, operator can review QC result of 24 parameters
through QC Query. Click QC Query to enter the interface as figure 8-11.
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Figure 8-11 X-R QC Query Interface
Click Pgprv or Pgnex to review the data. Operator could review 31 items
data at most. Click D_All to delete all data.
The difference to X and L-J QC Query is: each page in the X-R QC Query
interface display three QC results that include mean value and range. But the
first page of the first two columns is total mean and average range in the X-R
QC Query.
The QC data would update after running two new controls.
8.7 X QC
In X QC, analyzer should aspirate control to operate QC. The operator
could perform QC with 20 test parameters. Considering the different needs,
selecting partial parameters for QC is available. 3 QC documents of high,
normal and low are provided for saving.
8.7.1 X QC Edit
Before QC analysis, operator should finish QC Edit as the follows:
1. In the main interface, click “QC”, then click “X QC”, enter X QC Edit
interface.(see figure 8-12)
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Figure 8-12 X QC Edit Interface 1
Figure 8-12 X QC Edit Interface 2

2. Select corresponding level: low 1, low 2, low 3; normal 1, normal 2, normal
3; High 1, High 2, High 3.
3. Input lot NO., and select expiry date according to control instruction.
4. Input assay and limit value according to control instruction.
After QC Edit, click “Save”, the dialog box that whether to save the result or not
will display. (See figure 8-14).
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Figure 8-13 save settings
8.7.2 X QC Run
In X QC interface, click QC Run, enter the interface as figure 8-14:
Figure 8-14 X QC Run Interface

Select the level, lot No. and expiry date that X QC Edit selected.
In QC interface, system displays two control results, and calculates the
mean value automatically after finishing the second QC count. The column of
mean value show the mean value, the column of reference range show
reference range that user input in the QC Edit.
In the QC Run interface, place the prepared control in Emerge place; the
analyzer will automatically aspirate the controls to start analysis. If the
reference value of current group is empty, the system will alarm and cannot run
the QC count. Back to QC edit interface, then input QC reference value and
limit of deviation for running QC count. If run a background QC, the system will
alarm QC result is invalid.
8.7.3 X QC Graph Analysis

After QC Run, operator can review QC results of 20 parameters through
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QC Graph. In X QC interface, click QC Analysis, then enter the interface as

figure 8-15:
Figure 8-15 X QC Analysis
The dot on the X QC Graph indicates mean value of two QC results.

There are low, normal and high graphs. If select group 1 and low level to run a
control sample, the control dot will present in low 1 graph. Other selections
will present in corresponding graph.
QC results are arranged in graphs according to storage time. The latest is
on the left side and its serial number is 1.
QC graph instruction:
3、 Every parameter graph’s upper transverse line means assay plus limit.
4、 Every parameter graph’s lower transverse line means assay subtract
limit.
j) upper limit —— assay + limit
k) middle line —— assay
l) lower limit —— assay - limit
corresponding graph, it means the dot is under control range. If not, the dot is
not under control range.
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9.1 Overview
Analyzer is detected and calibrated at the factory just prior to shipment.
For some reasons the result may be a little out of the range. Calibration is to
insure the accuracy of results. Calibration is a process to standardize the
analyzer by its deviation of value and parameter, calibration factor.
The instrument provides three calibration modes: Calibrator Calibration,
Whole Blood Calibration and Manual Calibration.
CAUTION
 Only calibrators recommended by NeoMedica can be used to accomplish
the calibration.
 Follow the use instruction to store and use calibrator.
 Check if the container is broken or cracked before using the calibrator.
 Make sure the calibrators are brought to room temperature and well mixed
slowly before use.
 Make sure the calibrators are within the expiry date.
 Make sure the analyzer without problem and precision meet the
requirement before calibration.
 Never apply to the laboratory or clinic use unless all the parameters are
accurately calibrated.
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in Query. Make sure the CVs are accordance with table 9-2 precision;
Table 9-2 Precision

Parameter Precision（CV/%） Range
WBC ≤1.5% 4.0×10 /L ~ 15.0×109/L
9
RBC ≤1.0% 3.00×1012/L ~ 6.00×1012/L

HGB ≤1.5% 100 g/L ~ 180g/L
HCT ≤2.0% 35% ~ 50%
MCV ≤1.0% 70fL ~ 120fL
PLT ≤4.0% 100×109/L ~ 500×109/L
(5)Carryover is determined by running high and low controls of WBC, RBC,

HGB and PLT. The high control is run in triplicate follow by three low control
running cycles. The carryover is calculated by the following formula and result
is confirmed to table 9-3.
Table 9-3 Carryover

Parameter Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
PLT ≤0.5%
9.4 Calibration Mode
9.4.1 Calibrated Calibration

In main interface, click “Cal”, then select calibrator calibration mode into the
interface as figure 9-1. And calibrate as follows：
1. Input lot NO. and expiry date according to the calibrator instruction;
2. Select the parameter needed. Default select all;
3. Input the reference value according to the calibrator instruction and the
reference value of parameters do not need to be calibrated is blank.
4. Press “Start Calibrate Counting” button to start calibrate. The analyzer
could automatically calculate the mean value of 11 tests at most.
NeoMedica recommend testing 3 to 5 times at least.
5. The new calibration coefficient is calculated according to the reference
value of calibrators and mean. Click Save to save the new calibration
coefficient that calculated by system automatically.
6. Click Print to print the new calibration coefficient; and click Back to exit
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system calibration.
Figure 9-1 Calibrator Calibration Mode 1
99
NOTE
 The analyzer can calibrate a certain or all parameters of WIC，WOC，RBC，
HGB，MCV，MPV, RDW_CV, RDW_SD, PLT，PDW.
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 If you do not press the save button to save the data before press the return
push-button, the data will be lost.
7. Validation of Calibrated coefficient

After calibration, NeoMedica recommend to follow the steps below to validate
the calibrated coefficients:
(1) Test the calibrators three times, and check whether the results are within
the allowed range.
(2) Analyze high, normal and low controls, and each control should be tested
for three times at least and check whether the results are within the
allowed range.
(3) Analyze three normal fresh blood samples, three times for each at least.
And check whether the results are within the allowed range.
The principles of new calibration value:
 Mean value=(value1+value2+value3+value4)/4
 New calibration value=(reference/mean value)×former calibration
value
 If the new calibration value<70%, consider it equals to 70%; if the new
calibration value>130%, consider it equals to 130%
For example: the reference value of PLT of the calibrator is 220, current
calibration value is 103% and mean value is 230, thus the new calibration
value is;
New calibration value =103%×220/230
=98.52%
NOTE
 The calibration coefficient is allowed in the range of 70%~130%, if the
test values exceed the limit; the critical value in the limit range should
be selected as the new coefficient for calibration. And in that case,
operator should find out reasons and calibrate again.
9.4.2 Whole Blood Calibration

In main interface, click Cal, then select Blood Cal, enter the interface
as the figure 9-2.
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Figure 9-2 Whole Blood Calibration 1

Calibrate the analyzer as follows:
(1) Select the desired parameters and sample No..
(2) Prepare 3 to 5 normal whole blood samples according to the
collection of blood sample in Chapter 7.
(3) Use 3~5 prepared samples and test each of them for three times at least to
get the mean. Consider the mean or the data that obtained through the
reference method as reference value.
(4) Press “Start Calibrate Counting” button to start calibrate, the analyzer
could automatically calculate the mean value of 11 tests at most.
NeoMedica recommend testing 3 to 5 times at least)
(5)Repeat steps 4 until obtain more than three calibration coefficients. The
system will automatically calculate the mean value of each calibration
coefficient.
(6) Click Save to save the new calibration coefficient.
(7) Click Print to print the new calibration coefficient; Click Back to exit the
system calibration.
102

103
(1) Test the calibrators three times at least, and check whether the results are
within the allowed range.
for three times at least and check whether the results are within the
allowed range.
9.4.3 Manual Calibration

Following the steps below to operate manual calibration:
1. Operator chooses whole blood single sampling mode in the main interface,
and uses calibrator to test more than three times to obtain mean.
2. Click Cal in the main interface ,enter calibration interface, and click Manual
Cal into the interface as figure 9-3 show:
Figure 9-3 Manual Calibration
NOTE
 WBC Impedance Count (WIC) is the result of WBC that obtain through
electrical impedance method. And WBC Optical Count (WOC) is the result
of WBC that obtains through optics method.
 The analyzer can calibrate a certain or all parameters of WIC，WOC，RBC，
HGB，MCV，MPV, RDW_CV, RDW_SD, PLT，PDW.
 Click Save to save the data before exit system calibration or the data will
be loss.
104
3. Input the assay and values of desired parameters of calibrator, and click
Cal, the system will automatically calculate the new calibration
coefficient.(See figure 9-4)
Figure 9-4 Calculate Coefficient

4. Click Save to save the new setting.
Figure 9-5 save

(1) Test the calibrators three times at least, and check whether the results are
within the allowed range.
for three times at least and check whether the results are within the allowed
range.
105
Chapter 10 Maintenance and Care
Figure 10-1 Setup

2. Shutoff
To get correct results, it’s necessary to clean counting chambers and rinse
the flow system to prevent measurement errors caused by residues. Shutoff
program should be performed when the analyzer tests more than 500
specimens or finish today’s work. If continuously use the instrument, shutdown
program should be performed once at least every 24 hours. For detail
instructions, please refer to chapter 7 Daily Operation of Shutoff.
10.2.2 Weekly Maintenance

1. Surface Maintenance
Clear the smudge on the surface, especially the blood on the aspiration
probe and its surrounding, to remove the protein aggregation or debris to
reduce the possibility of the blockage. Wipe the outside of the probe and
surrounding with gauze soaked by litmusless detergent before cleaning other
parts.
CAUTION
 Never use corrosive acids, alkali or volatile organic solvent (such as
acetone, aether and chloroforms) to wipe the outside of the analyzer, but
only litmusless detergent.
107
2. Clean Aspiration Probe
Figure 10-2 Clean Aspiration probe

In the main interface select Maint, enter the interface as figure 10-2, and
select Clean Aspiration Probe to clean aspiration probe. Regular cleaning of
the clean aspiration probe ensures the accuracy and precision of performance,
prevent block caused by reagent and blood residue. The clean aspiration
probe will be dirty after a long time use, so remove it and clean the clean
aspiration probe with distilled water are necessary. Aspiration probe must be
cleaned with detergent firstly and then with distilled water again. For detailed
NeoMedica Customer Support Centre.
10.2.3 Monthly Maintenance

1. Check and Clean Reagent Syringes
The Reagent Syringes need to be cleaned on a regular basis to prevent
reagent residue buildup, which may cause leakage or improper functioning.
Syringes should be cleaned one at a time to ensure that each syringe is placed
in the correct position. Replace each syringe after it is cleaned and then
remove the next one to be cleaned.
108
Materials Required:
1. A large container filled with approximately 500 mL of deionized water;
2. Clean and soft cloth;
3. Deionized water;
4. Small container of appropriate reagent to refill the clean syringes;
5. Appropriate personal protective equipment.
Clean Procedure:
1. Empty the flow system;
2. Remove the front covers to gain access to the Syringe Assembly.
3. Lift the syringe out of the snap-in bracket.
4. Aspirate the deionized water into the syringe until it is full. Continue to pull
on the plunger until it is removed from the barrel.
5. Rinse the plunger and barrel thoroughly with deinoized water. If the seal
ring has been worn to be replaced with new.
6. Carefully reinsert the plunger into the wet barrel.
7. When the syringe has been reinstalled, run several background counts
and observe the action of each syringe during the cycle. The plunger
should move smoothly up and down and the syringe should not leak.
CAUTION
 Do not push or pull on the plunger when the syringe is dry, as it may
damage the plunger. Avoid touching the plunger because oil from the
fingers may cause it to move erratically.
2. Maintenance of mechanical parts
It mainly aims at mechanism maintenance, including lubricate electricity
axis, X, Y leader of sampling organ etc. In the red area picture below shows:
109
Figure 10-3 Maintenance of mechanical parts
10.3 Maintenance procedure

In main interface, click Maint into the interface as figure 10-4:
110
Figure 10-4 Maintenance Interface

The analyzer offers the following three maintenance operations on flow
system:
 Prime: Aspirate all or depart of reagents to the corresponding tube to
replace the reagent.
 Clean: Clean count chamber, aspiration probe, etc.
 Empty: Empty count chamber, waste chamber, vacuum accumulator or all
tube.
10.3.1 Fluidics Cleaning

In the following conditions, perform this operation:
 Use the analyzer first time;
 Replace all reagents;
 The tubes are dirty, need to clean;
 Make sure the analyzer has problem.
Operate as the following steps:
1. Select Prime Fluidics in the Maintain interface;
2. The analyzer starts to replace diluent, detergent and sheath, and display
the progress bar at the bottom of screen.
3. The operation is completed and back to the Maintain interface.(see figure
10-5)
111
2. The analyzer start to perform the function and display the process bar at
the bottom of screen;
3. The operation is completed and back to the MAINT interface.
10.3.3 Detergent Replacement

In the following three conditions, perform this operation:
 There are bubbles in the detergent tubing;
 The detergent in tubing is contaminated;
 Replace a new detergent.
The procedures as follows:

1. Select Prime Detergent in MAINT interface;
10.3.4 Sheath Replacement

In the following three conditions, perform this operation:
 Three are bubbles in the WOC Flow Cell;
 The sheath in tubing is contaminated;
 Replace a new sheath.
The procedures as follows:

1. Select Prime Sheath in MAINT interface;
10.3.5 Cauterize Aperture

Cauterize both sides of the ruby aperture with a high voltage to clear
protein, dust etc. that adhere or block on the aperture, to prevent and eliminate
blockage associating. The procedures as follows:
1. Select Cauterize Aperture in the MAINT interface;
the bottom of the screen;
3. The operation is completed and back to the MAINT interface.(see figure
10-6)
113
Clean Transducers function is to rinse transducers with diluent and scour

it with play bubbles. The procedures as the follows:
1. Select Clean Transducers in the MAINT interface;
If blockage is severe, select Empty WBC Cup or Empty RBC Cup, the
analyzer will automatically empty the liquid in both sides of the aperture. And
remove the ruby aperture, brush it with probe detergent or enzyme, then wash
it with distilled water. If the ruby aperture has been reinstalled, run several
times of background counts to check whether it is blockage.
CAUTION
 Consider the probe detergent is corrosive; operator should wear lab coats,
gloves, and follow required laboratory or clinical procedures.
10.3.8 Prepare Shipping

Perform this function before shipping or leave unused for a long time, the
procedures as the follows:
(1) Take out the diluent inlet tube connecting with the diluent port on the rear
panel from container, discharge the diluent remained in tube;
(2) Take out the detergent inlet tube connecting with the detergent port on the
rear panel from the container, discharge the detergent remained in tube;
(3) Take out the sheath inlet tube connecting with the sheath port on the rear
panel from container, discharge the sheath remained in tube;
(4) Keep the remaining reagents in their containers and store them according
to instructions. Operator should establish and confirm to the effective
storage measures to prevent reagent from deteriorated, misusage or
misdrinking. The reagent should be away from temperature extremes.
(5) Select Prepare Shipping in the MAINT interface;
(6) The analyzer start to perform the function and display the process bar at
(7) The operation is completed and back to the MAINT interface. (see the
figure 10-7)
115
Figure 10-7 Prepare Shipping
10.3.9 Other Maintenances

Clean Aspiration Probe--------scour the inside of aspiration probe with diluent.
Clean sheath channel--------clean Pre-mixing chamber and WOC Flow Cell.
Clean Impedance Channels--------clean WBC/RBC counting chamber and
volumetric metering tube.
Open Press Control Module--------provide pressure for press chamber and
negative press for negative press chamber.
Close Press Control Module--------close the pressure on the press chamber
and negative press chamber.
Empty Waste Chamber--------discharge the waste remained in waste chamber
to the outside of analyzer.
Empty RBC Transducer--------empty the diluent remained in the RBC cup.
116
Chapter 11 Troubleshooting
117
authorized engineer. The operator can correct sample measurement problems

with assistance from NeoMedica engineers.
Step3: Corrective Action

Corrective Action means operator taking appropriate action to correct the
problem. If operator can correct the problem, with or without technical
assistance from the manufacture, normal operation can quickly resume.
11.3 Obtaining Technical Assistance

Technical assistance is obtained by calling the NeoMedica Customer
Support Centre. When assistance is needed, please be prepared to provide
the following information for Customer Support Specialists:
(1) The analyzer model;
(2) Serial number and version number;
(3) Description of the problem and surroundings, including status and
operation;
(4) The lot number of the reagents (sheath, diluent, detergent etc.)
(5) Related data and report of the problem.
Familiar problems and disposals are given in this Chapter. The operator
can identify the cause according to the warning information and operate
according to Troubleshooting Guidance.
11.4 Troubleshooting
Familiar problems and corrective actions are listed as follows. If the
problems cannot be corrected, or technical assistance is needed, please
contact with NeoMedica Customer Support Centre.
11.4.1 Faults Related to Reagents
Fault Probable Cause Corrective Action

 Check that if diulent is run out.
 Perform Maint→Prime Diluent.
Diluent empty Diluent is run out.
 If fault still occurs, please contact
with NeoMedica.
 Check that if the detergent is run out.
Detergent  Perform Maint→Prime Detergent.
Detergent is run out.
empty  If the fault still occurs, please contact
with NeoMedica.
119
 Check that if the sheath is run out.

 Perform Maint→Prime Sheath.
Sheath empty Sheath is run out
 If the fault still occurs, please contact
with NeoMedica.
 Check that if the waste container is
full.
Waste container is
 Check that if the sensor is wet or
Waste full full or waste sensor
short circuit.
is in fault.
with NeoMedica.
11.4.2 Faults Related to Test Value

 Check that if the reagents are
contaminated or overdue.
 Perform Maint→Prime Fluidics to
Reagents are rinse the flow system.
High
contaminated  If the fault still occurs, perform
background
oroverdue; Reagent aint→Clean Transducers. Run a
value
tube Contaminated. background test again to check if the fault
disappeared.
with NeoMedica.
 Check that if Detergent is run out.
WOC/HGB cup is  Perform Maint→“Empty WOC/HGB
HGB
dirty, Detergent is cup” and“Prime HGB cup”to clean the
inaccuracy
overdue. HGB cup, if the fault still occurs, please
contact with NeoMedica.
 Perform Cauterize Aperture or Flush
Aperture in the MAINT interface. Then run
a background counting to check the count
ruby aperture clogged; time.
RBC clog WBC counting time  If fault still occurs, inject probe
incorrect; detergent with the syringe into RBC cup
to soak the ruby aperture.
 If fault still occurs, please contact with
NeoMedica.
120
 Check that the diluent or detergent if

run out.
Diluent or etergent run  Check the reagent tubing connection,
out or deficient. prevent leakage.
RBC bubble
Reagent tubing loose  Perform Tubing Clean in MAINT
leads to leakage. interface.
with NeoMedica.
11.4.3 Fault Related to Hard Ware

 The power wire is  Check the power wire connection.

not connection well  Check whether the fuse has burned
No response
with the power socket. out.
when startup
 The fuse may be  If the fault still occurs, turn off the
burnout. power, and contact with NeoMedica.
 Moto connecting
wire loose.
 Travel
Moto sounds Turn off the power, and contact with
Optocoupler problem.
abnormally NeoMedica.
 Moto problem;
 Moto drive circuit
problem.
 Check the power wire and connecting
wire of the printer. If the printer still
doesn’t work, please re-plug wires and
restart the computer and printer.
 Connecting wire
Printer no  If the fault still occurs, connect the
problem.
response printer to another normal computer
 Printer problem
separately and install the driver to test the
printer if it is normal.
with NeoMedica.
121
Appendix A Specifications
A.1 Technical Specifications
A.1.1 Parameters

MON% Monocyte Percent %
NEU% Neutrophile Percent %
EOS% Eosinophile Percent %
BAS% Basophil Percent %
MON# Monocyte Count 109cells/L
NEU# Neutrophile Granulocyte Count 109cells/L
EOS# Eosinophile Granulocyte Count 109cells/L
BAS# Basophil Granulocyte Count 109cells/L
HGB Hemoglobin g/L
RDW_CV Red Blood Cell Distribution Width repeat precision %
PCT Plateletcrit %
P_LCC Large Platelet Count 109cells/L
P_LCR Large Platelet Percent %
RETIC Reticulocyte %
RETIC_ABS Reticulocyte absolute number 109/ul
IIRF Immature Reticulocyte Fraction %
A.1.2 Test Speed

Not less than 60 / hour
122
A.1.3 QC Mode
There are four QC modes, L-J QC, X-B QC, X-R QC and X QC.
A.1.4 Reagents of Product

The reagents used in analyzer: diluent, Detergent, detergent and sheath. The
detail information about them is in A.4 Reagent Specification.
A.1.5 Calibration Mode

The modes of calibration are Calibrator Calibration, Whole Blood Calibration,
and Manual Calibration.
A.1.6 Parameters Measurement and Calculation

(1) The laser light method for determining the quantity and Five-Part-Diff of
WBC.
(2) Electrical impedance method for determining the quantity of RBC and PLT.
(3) The colorimetric method for determining the content of HGB.
(4) MCV，HCT，RDW，MPV，PDW，MCH，MCHC，PCT are obtained directly
by calculating the stored data.
A.1.7 Input/output Devices

(1) Outer computer;
(2) Outer printer (optional);
CAUTION
 Computer, printer and other external devices must be passed CCC(C&E)
Compulsory Certification. It may cause the system work improper system
work and personal injury by using substandard external devices.
123
A.2 Physical Specifications
A.2.1 Power Requirement
Optimum work Voltage Work Voltage range Frequency

AC 220V AC 100V～240V 50/60 Hz
A.2.2 Environment Requirement

(1) Temperature: 15°C~35°C;
(2) Relative Humidity: ≤85％;
(3) Barometric Pressure: 60kPa~106kPa;
A.2.3 Storage Environment

(1) Temperature: -20°C~55°C;
(2) Relative Humidity: ≤95%;
(3) Barometric Pressure: 50kPa~106kPa;
A.2.4 Size and Weight

(1) Height: about 488.5mm;
(2) Length: about 598.5mm ;
(3) Width: about 585mm;
(4) Weight: about 65Kg;
A.2.5 Waste Disposal

According to the standard of local or nation dispose the waste.
A.2.6 Minimum Sample Volume

Whole blood sampling mode 20µL
Pre-dilution Sampling Mode 20 µL
A.2.7 Dilution Ratio

(1) WBC: about 1:108
(2) RBC/PLT about 1:12500
A.2.8 Counting Aperture

(1) WBC: 100μm;
(2) RBC/PLT: 68μm;
A.2.9 HGB measurement

(1) Measure HGB in WBC/HGB cup;
(2) The illuminant is led, and the wavelength is 540nm.
124
A.3 Performance Index
A.3.1 Precision
Acceptable Limits
Parameter Precision Range
（CV%）
WBC 4.0 x109 /L ~15.0x109 /L ≤1.5%
RBC 3.00 x1012 /L ~6.00x1012 /L ≤1.0%
HGB 100 g/L ~180 g/L ≤1.5%
PLT 100 x109 /L ~500x109 /L ≤4.0%
HCT 35%~50% ≤2.0%
MCV 70 fL ~120 fL ≤1.0%
A.3.2 Linearity
Parameter Linearity Range Acceptable Limits
0 x109 /L ~10.0x109 /L ≤±0.3 x109 /L
WBC
10.1 x109 /L ~99.9x109 /L ≤±5%
0.10 x1012 /L ~1.00x1012 /L ≤±0.05 x1012 /L
RBC
1.01 x1012 /L ~7.00x1012 /L ≤±5%
0 g/L ~70 g/L ≤±2 g/L
HGB
71 g/L ~300 g/L ≤±2%
0x109 /L ~100x109 /L ≤±10 x109 /L
PLT
101 x109 /L ~999x109 /L ≤±10%
A.3.3 Accuracy of WBC five part differential

The measurement values of NEU, LYM, MON, EOS and BAS are in the
acceptable range. (99% of the confidence interval)
A.3.4 Carryover
Parameter Measurement Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
PLT ≤0.5%
A.3.5 Background Counting
Parameter Measured Value Range

WBC ≤0.20x109 /L
RBC ≤0.02x1012 /L
HGB ≤1g /L
PLT ≤10.0x109 /L
125
A.3.6 Accuracy
Parameter Acceptable Range (%)
WBC ≤±2.0%
RBC ≤±1.5%
HGB ≤±1.5%
MCV ≤±0.5%
HCT ≤±1.0%
PLT ≤±4.0%
A.3.7 Display Range of Main Parameter

Parameter Display Range
WBC 0～200.0 x 109/L
RBC 0～18.00 x 1012/L
HGB 0～300g/L
HCT 0%～80%
PLT 0～2000 x 109/L
A.4 Reagent Specifications
Name Model Specification

Diluent NCC-51 20L
Detergent NCC-51 20L
Sheath NCC-51 10L/20L
Detergent NCC-51 500mL/1L
CAUTION
 Do not pour the remaining reagent in it when replace a new reagent, or it
will lead to cross contamination of the reagents.
A.5 Reagent Consumption
Operation Diluent Detergent Sheath Lyse

Startup 36mL 25mL 9mL 3mL
Counting 41mL 18mL 7mL 0.4mL
Prime (Clean) 36mL 24mL 9mL 3mL
shutdown 30mL 10mL 9mL 0mL
126
A.6 Parameters Alert Messages
Suspect Suspect
Interpretive
Parameter Data Alerts Paramete Population
Messages
r Flags Flags
If the result
below lower
limit, it displays Leukopenia
in blue and NWBC Leukocytosis
marked L; FWBC When RRBC?
WBC WBC
If the result NRBC alarm, switch to
above upper RRBC RRBC mode for
limit, it displays counting again.
in red and
marked H;
Neutropenia
Differential
Neutrophilia
NEU BAND
Lymphopenia
LYM DFLT IG
Same as WBC Lymphocytosis
MON (NLMEB) BLAST
Monocytosis
EOS VARLYM
Eosinophilia
BAS
Basophilia
MPV
LRI Thrombocytopenia
Suppresse
PLT URI Thrombocytosis
Same as WBC d (not
MPV LURI Microcytic PLT
displayed
PLTR Macrocytic PLT
or printed )
127
Appendix B External communication protocol
A. Communication Protocol
Information is transferred by the following methods.
<SB>information<EB><CR>
<SB> is Start Block Character needs 1byte corresponds to ASCII <VT>
hexadecimal 0x0B
<EB> is End Block Character needs 1byte corresponds to ASCII <FS>
Hexadecimal 0x1C
<CR> is Carriage Return needs 1byte corresponds to ASCII <CR>
hexadecimal 0x0D
Information is the data that we want to transfer. Please refer to the following for
details.
B. Information Grammar
1. Delimiter
| --- Fields Delimiter
^ ---Component Delimiter
& --- Subcomponent Delimiter
~ --- Repeat Delimiter
\ --- Escape Character
2. Data Type
CX extended composite id which check digit
CE code element
CM composite
CQ composite quantity with units
DR date time range
DT data
DLN driver’s license number
EI entity identifier
HD hierarchic designator
FN family name
FT formatter text
IS coded value for user-defined tables
ID coded values for HL7 tables
JCC job code
NM numeric
PT processing type
PL person location
ST string
SI sequence ID
128
TS time stamp
TQ timing quantity
TX text data
XAD extended address
XCN extended composite ID number and name
XON extended composite name and ID number for organizations
XPN extended person name
XTN extended telecommunications number
VID version identifier
3. Field Meaning
3.1. There is a message header at the beginning of each message. It is
MSH field.
The meaning of MSH is shown as below
No. Field Data Type Length Explanation
1 Field mark ST 1 Separator
2 Encoding chars ST 4 Separator listing
Sending
3 EI 180 Sending end applications
Application
4 Sending Facility EI 180 Sending end facility
Receiving Receiving end
5 EI 180
Application applications
6 Receiving Facility EI 180 Receiving end facility
Date Time Current message event,
7 TS 26
Message system time
8 Security ST 40 Security
9 Message Type CM 7 Message Type
Message control ID is
Message Control used to distinguish
10 ST 20
ID different messages. See
the table below.
11 Processing ID PT 3 Dispose of ID P Product
12 Version ID VID 60 HL7 version is 2.3.1
Application
13 Acknowledgment IS 1 Set null
Type
14 Retain
15 Retain
16 Retain
17 Retain
18 Encoder ST Encoding is UNICODE
MSH-10 Description
0001 Instrument transmits results automatically.
129
1001 LIS responses, instrument transmits results automatically.

Example:
MSH|^~\&|URI|UT-5200|LIS|PC|20100930100436||ORU^R01|0001|P|2.3.1|1|||
||UNICODE
3.2. PID--- Definition of patients' data field

Identify different
1 Set ID PID SI 4 fields, fill with 1
generally.
Patient ID., hospital
2 Patient ID EI 20
No., set null
Indicate batch number
3 Patient Identifier List CX 20
when QC
4 Alternate Patient ID CX 20 Bed No.
5 Patient Name XPN 48 Name
Mother’s Maiden Mother’s Maiden
6 XPN 48
Name Name, set null
Birthday；Indicate
7 Date/Time of Birth TS 26
validity when QC
8 Sex IS 1 Male or female
9 Patient Alias XPN 48 Retain patient alias
10 Race CE 80 Retain race
Retain patient
11 Patient Address XAD 106
address
12 County Code IS 4 Retain county code
13 Phone Number XTN 40 Retain phone No.
Retain office phone
13 Phone Number Bus XTN 40
No.
14 Primary Language CE 60 Retain mother tongue
15 Marital Status CE 80 Retain Marital Status
16 Religion CE 80 Retain religion
The rest part is not
…
needed to be filled.
Example: PID|1|1010051|A1123145|15|Mary||19811011|M
3.3. PV1---Definition of patient visiting record field

Identify different
1 Set ID PV1 SI 4 fields, fill with 1
generally.
2 Patient Class IS 1 Patient category
3 Assigned Patient PL 80 Be used to indicate
130
Location patient department

Example: PV1|1Clinic| Surgery |
3.4. OBR--- Definition of Doctor's Advice

Identify different
1 Set ID OBR SI 4 fields, fill with 1
generally.
2 Placer Order Number EI 22 Serial number
Assigned Patient
3 EI 22 Sample number
Location
4 Universal Service ID CE 200 Universal service ID
5 Priority ID 2 Priority set null
6 Requested Date Time TS 26 Application time
Observation Date Inspection starting
7 TS 26
Time time, set null
Observation Date
8 TS 26 Inspection end time
Time end
Specimen collection
9 Collection Volume CQ 20
capacity, set null
10 Collector Identifier XCN 60 Sender name
Sample handling
11 SPE Action Code ID 1
code, set null
12 Danger Code CE 60 Danger code alarm
"Diagnosis" ^
"Remark", each length
13 Relevant Clinical Info ST 200
should not be more
than 100 bytes
SPE Received Date
14 TS 26 Sample receiving time
Time
Sample classification,
15 SPE Source CM 300
blood, urine etc.
16 Ordering Provider XCN 120 Inspector name
Order Callback Callback phone, set
17 XTN 40
Phone Number null
Sender field 1,
18 Placer Field1 ST 60
Inspection department
19 Placer Field2 ST 60 Set null
Operator field 1, set
20 Filler Field1 ST 60
null
The rest part is not
… Set null
needed to be filled.
28 Result Copies to XCN 60 Verifier
131
Example：
OBR|1|1010051|000001|URI^UT-5200||20101010093000||20101010093500||
sender||| diagnosis^remark||BLD|Inspector||||||||||||verifier|
3.5. OBX
Identify different
1 Set ID OBX SI 4 fields, fill with 1
generally.
NM means figure
2 Value Type ID 3 type, ST means value
type
Observe identifier
3 Observation Identifier CE 590
name
Observe sub-id
4 Observation Sub ID ST 20
project name
5 Observation value ST 65535 Check result
6 Units CE 90 Unit
Reference range is
from small to big; QC
7 References Range ST 90
means reference
value and deviation.
H,L and N indicate
8 Abnormal Flags ID 5 high, low and normal
value respectively.
9 Probability ID 5 Probability, set null
C indicates WBC and
Nature of Abnormal RBC clog; B indicates
10 ID 2
Test bubble, when normal,
set null
Observe results, take
11 Observe Status ID 1
F for final result.
The time for observing
12 Date Last Observe TS 26
normal value, set null
User Defined Access
13 ST 20 Original results
Checks
Example: OBX|1|NM|WBC||8.21|10^9/L|4.00-10.00|L|||F||
3.6. MSA
Confirmation code: AA
Acknowledgment is for receiving, AE for
1 ID 2
Code error and AR for
refusing.
132
Message Control ID
2 ST 20
3 Text Message ST 80 Message
Expected Sequence
4 NM 15
Number
Delayed
5 Acknowledgment ID 1
Type
6 Error Condition CE 100 Error condition
MMSA-6 is used to indicate different errors, see the table below.

MSA-1 MSA-6 MSA-3 False Description
AA 0 Message accepted Receive successfully
The fields order in
Segment sequence message is not correct, or
101
error the necessary fields are
lost.
Necessary fields of a
102 Required field missing
AE paragraph are lost.
Data type of fields is false.
103 Data type error For example, digital is
changed into character.
104 Key not found Key identifier is not found
105 Resend Resend data
Unsupported message Unsupported message
201
type type
Unsupported event
202 Unsupported event code
code
Unsupported Unsupported processing
203
processing id ID
Unsupported version
204 Unsupported version ID
id
Unknown key identifier，
AR For example, transmit an
205 Unknown key identifier
inexistent patient
information.
206 Duplicate key identifier Duplicate key identifier
Affairs in application
Application record storage level can't be
207
locked carried out. For example,
database is locked
Application internal Other errors in unknown
208
error application.
133
209 Application unready Application is not ready

3.7. ERR
1 Error Code and CM 80 Code and position
Location error
ERR-1
Assembly 1 Assembly 2 Assembly 3 Explanation
Record
The test tube record has
001 already Test tube No.
already existed.
exist
Lis
Lis receiving error,
002 Recieved Test tube No.
resending data is required.
Faild
Read REQ
003 Test tube No. Fail to read request form.
error
Read
Instrument fails to read test
004 BarCode Test tube rack No.
tube number.
Errer
3.8. QRD
1 Query Date/Time TS 26 Query time
Query Format
2 ID 1 D （display format）
Code
3 Query Priority ID 1 I（Immediate）
Distinguish different
queries ,accumulate with
4 Query ID ST 10
query times. The initial
value is 1.
Deferred
5 ID 1 Set null
Response Type
Deferred
6 Response TS 26 Set null
Date/Time
Quantity Limited
7 CQ 10 RD（Records）
Request
Take as a test tube code
8 Who Subject Filter XCN 60
\ sample number.
9 What Subject Filter CE 60 OTH
What Department
10 CE 60 Set null
Data Code
What Data Code
11 CM 20 Set null
Value Qual.
134
Query Results
12 ID 1
Level
3.9. QRF
Where Subject
1 ST 20 Take UT-5200
Filter
When Data Start
2 TS 26 Application time
Date/Time
When Data End
3 TS 26 Deadline
Date/Time
What User
4 ST 60 Set null
Qualifier
Other QRY Subject
5 ST 60 Set null
Filter
RCT(Specimen
Which Date/Time receipt date/time,
6 ID 12
Qualifier receipt of specimen in
filling ancillary (Lab))
Which Date/Time
7 ID 12 ANY(Any status)
Status Qualifier
Date/Time ALL(All values within
8 ID 12
Selection Qualifier the range)
When
9 Quantity/Timing TQ 60 Set null
Qualifier
3.10. QSP
1 Set ID - DSP 4 SI
2 Display Level SI 4
3 Data Line TX 300 Content queried
4 Logical Break Point ST 4
5 Result ID TX 20
Use QSP-1 to distinguish different queried information in QSP fields.

Set ID – DSP Message
1 Test Tube Number
2 Serial Number
3 Name
4 Sex
5 Birthday
6 Blood Type
7 Group
135
8 Patient Number
9 Bed Number
10 Patient Type
11 Department
12 Sender
13 Inspector
14 Verifier
15 BLDV is for venous blood, BLDC is for peripheral blood.
16 Clinical diagnosis
17 Remark
18 Sampling time, sending time
19 inspection time
Example
DSP|1||Mary||<CR>
4. Communication process
4.1. Instrument transmits test results to lis server
NCC-51 Lis
ORU^R01 server
<SB>
MSH
PID
PV1
OBR
OBX
OBX
……
<EB><CR>
OBX fields can be repeated. Transmitted test results include patient

information, 24 parameters, 2 histograms and 2 scatter plots. The 2 histograms
and 2 scatter plots are BMP format and transmitted with base64 code;
For example：
Instrument transmits test results to lis server
<SB>
136
Appendix D Toxic and Hazardous Substances or
Elements
Toxic and Hazardous Substances or Elements
Polybromi-
Polybrominate-
Parts Plumbum Mercur Cadmiu Chromium nated
d Diphenyl
（Pb） y（Hg） m（Cd） VI（Cr(VI)） Biphanyls(
Ethers（PBDE）
PBB)
Shell ○ ○ ○ ○ ○ ○
Printed
circuit
× ○ ○ ○ ○ ○
board
Assembly
Sheet
metal ○ ○ ○ × ○ ○
Parts
Hos Plastic
t ○ ○ ○ ○ ○ ○
Parts
Machining
○ ○ ○ ○ ○ ○
parts
Hardware ○ ○ ○ ○ ○ ○
Flow
System ○ ○ ○ ○ ○ ○
Parts
Cable ○ ○ ○ ○ ○ ○
Accessories ○ ○ ○ ○ ○ ○
Packaging
○ ○ ○ ○ ○ ○
Materials
○：The content of toxic or hazardous substance in the homogeneous materials of the parts above is
in the acceptable range of SJ/T11363-2006.
×：The content of toxic or hazardous substance is exceed the acceptable range of SJ/T11363-2006
in at least one kind of homogeneous material of the parts above.
(The circuit board used lead solder in machining process and sonme parts of the board contain
plumb；And some sheetmetal parts use chromium VI for surface ）
Memo：Printed circuit board Assembly is consist of printed circuit board, capacitance, connector
and other parts. Lithium cell is detachable and recyclable part.
140
-5500
I.
1. -
2. ).
3. ).
1. Diluent.
2.
3. Lyse.
4.
5. Detergent.
6. Sheath.
7.
1.
2.
3.
1. mass.
2. USB.
3. COM.
4.
5.
6.
II.
A.
1.
Test
Data
Maint
QC
Cal
Setup
2.
Next serial number
Mode
Transfer
Print
Print preview
B.
1.
 Lyse Lyse
2.
 Diluent Diluent
3.
 Sheath Sheath
4.
 Waste Waste
BNC SENSOR
C.

 background
 Setup > Maintenance > click Auto Blank
background
 Background :
WBC ≤0 20×109L
RBC ≤0 02×1012L
HGB ≤1 /
PLT ≤10 0×109L
Background
D.
 QC
 QC - - -
E.
 Click Data
Ctrl Shift
 Name
 Sex
 Age
 Blood
 Group
 ID 0000000 9999999 ID
 Case ID
 Bed NO
 Department
 Checker
 Sender
 Assessor
III.
A.
 Count ↓
B.
 Data > Query Click
Neo-Diluent CD5 1 Package insert
• Prime the reagents through instruments

WHOLE BLOOD DILUTING REAGENT (Operator's manual)
• When installing a new LOT of reagents
PRODUCT NAME recalibrate the instrument (Operator's manual)
Neo-Diluent CD5
Cat.No. / REF N12145 20 L- cubitainer STORAGE & STABILITY
The reagent has an unopened stability of 24
INTENDENT USE months from date of manufacture when stored at 5°C-
For In Vitro Diagnostic Use Only 30°C. See package label for expiry date.
Once installed reagent on the instrument, is stable
This diluent is necessary for the process involved in for 60 days.
counting (and differentiating) the blood cells. Neo- DO NOT use reagent once frozen.
Diluent CD5 is Reagents for Automated Hematology
Analyzer Abbott CD3000, CD3500, CD3700. EXPECTED RESULTS
Intended for use in a set NeoMedica, with Neo- Performance should be within instrument
WIC/HGB Lyse, Neo-Detergent CD5 and Neo-Sheath. specification.
SUMMARY & PRINCIPLE LIMITATIONS
A sample volume of a whole blood specimen is Reagent has to be used within the ambient
aspirated into the analyzer where a portion of it is temperature range of 15°C-30°C.
automatically diluted with Neo-Diluent CD5. NeoMedica reagents can be only used with other
Dilution of the sample is then introduced into Flow NeoMedica reagents. If the reagent is mixed with third
cytometer analyzer where the red blood cell count party reagents, incorrect results may be obtained.
(RBC) and the thrombocyte count (PLT) is measured.
Consult your specific instrument Operator’s Manual for MATERIALS REQUIRED BUT NOT PROVIDED
additional information with respect to procedures and Automated Hematology Analyzer (Cell Counter)
principles for whole blood hematological analysis. Abbott CD3000, CD3500, CD3700 .
• Neo-Detergent CD5
ACTIVE INGRIDIENTS Cat.No. / REF N 12325 20 L cubitainer
Sodium sulfate Anhydrous ≤ 1.0 % • Neo-Sheath
Sodium Chloride ≤ 8.3 % Cat.No. / REF N 12164 10L cubitainer
Anti-Microbial Agents ≤ 0.25 % Cat.No. / REF N 12165 20L cubitainer
Buffering Agents ≤ 0.3 % • Neo-WIC/HGB Lyse
Cat.No. / REF N 12233 3.8 L cubitainer
PRECAUTIONS • Neo-EZ-Cleanser
• Only for professional use. Cat.No. / REF N 12400 50 ml bottle
• Before use, please read Operator's manual of the
instrument carefully. SPECIMEN REQUIREMENTS
• Don't freeze. Blood specimens for hematological analysis may be
• Do not use reagents beyond the expiration date stored for up to 8 hours at 15°C-30°C or up to 24
printed on the label. hours after collection when refrigerated 2°C-8°C.
• Beafore use, check the package for signs of By taking samples from the fridge, they must be
damage. equal to room temperature with constant stirring
• Use within 60 days after opening the reagent.
• Don't ingest. Avoid skin and eyes contact. MANUFACTURER
• In case of contact, rinse with plenty of water NeoMedica d.o.o.
immediately. Bul. Sv.Cara Konstantina 82-86, 18000 Nis, Serbia
• Seek medical advice immediately in case of tel:+381 18 573822 fax:+381 18 573616
ingestion and / or eyes contact. email: ivd@neomedica.rs www.neomedica.rs
• Use Good Laboratory Practices when handling
these reagents. Wellkang Ltd t/a Wellkang Tech Consulting
Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
PERSONAL PROTECTION
Safety glasses and laboratory gloves are
recommended.
INSTRUCTION FOR USE

Person installing the reagents must be a trained
laboratory professional, versed for Abbott Hematology
Analyzer.
• Leave the reagents at room temperature (15°C-
30°C) for at least 24 hours.
• Connect the other reagents to the instrument (see
MATERIALS REQUIRED BUT NOT PROVIDED)
Version 16 SREN
1/1
Package insert
Neo-Detergent CD5 2
Reagent for washing STORAGE & STABILITY

Neo-Detergent CD5 months from date of manufacture when stored at 5°C-
Cat.No. / REF N12325 20 L- cubitainer 30°C in a dark place. See package label for expiry
date.
PRODUCT NAME Once installed reagent on the instrument, is stable
Neo-Detergent CD5 for 60 days.
DO NOT use reagent once frozen.
INTENDENT USE
For In Vitro Diagnostic Use Only EXPECTED RESULTS
Neo-Detergent CD5 is to be used to rinse CellDyn Performance should be within instrument
3000, 3500, 3700, hematological analyzers between specification.
measurements and cleaning.
It is designed for use with NeoMedica Set (Neo-Diluent LIMITATIONS
CD5 …). Reagent has to be used within the ambient
temperature range of 15°C-30°C.
SUMMARY & PRINCIPLE NeoMedica reagents can be only used with other
Neo-Detergent CD5 is a cleaning reagent that NeoMedica reagents. If the reagent is mixed with third
effectively cleans out cell debris, proteins and party reagents, incorrect results may be obtained.
triglycerides by detergent solubilization. Blood specimens for hematological analysis may be
stored for up to 8 hours at 15°C-30°C or up to 24
ACTIVE INGRIDIENTS hours after collection when refrigerated 2°C-8°C.
Sodium sulfate anhidr. ≤ 1.0 % By taking samples from the fridge, they must be
Sodium chloride ≤ 0.55 % equal to room temperature with constant stirring
Surfactant nonion ≤ 0.1 %
Anti-Microbial Agents ≤ 0.05 % MATERIALS REQUIRED BUT NOT PROVIDED
Cell Dyn3000, Cell Dyn 3500, Cell Dyn 3700.
PRECAUTIONS
Only for professional use. • Neo-Diluent-CD5
Before use, please read Operator's manual of the Cat.No. / REF N12145 20 L- cubitainer
instrument carefully. • Neo-Sheath
Don't freeze. Cat.No. / REF N12164 10 L- cubitainer
Do not use reagents beyond the expiration date printed
on the label
Use within 60 days after opening the reagent. MANUFACTURER
Don't ingest. Avoid skin and eyes contact. NeoMedica d.o.o.
In case of contact, rinse with plenty of water immediately. Bul.Sv.Cara Konstantina 82-86, 18000 Nis,
Seek medical advice immediately in case of ingestion Serbia
and / or eyes contact. tel:+381 18 573822 fax:+381 18 573616
Use Good Laboratory Practices when handling these email: ivd@neomedica.rs www.neomedica.rs
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE
• Person installing the reagents must be a trained Wellkang Ltd t/a Wellkang Tech Consulting
laboratory professional, versed for Abbott hematology Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
analyzers Cell Dyn series.
• Prime the reagents through instruments (Operator's
manual)
• When installing a new LOT of reagents recalibrate
the instrument (Operator's manual)
Version 16
1/1
Package insert
Neo-WIC/HGB Lyse 3
This reagent is used to lyse blood cells .

STORAGE & STABILITY
Cat.No. / REF N12233 3.8 L- cubitainer The reagent has an unopened stability of 24
months from date of manufacture when stored at 5°C-
PRODUCT NAME 30°C. See package label for expiry date.
Neo-WIC/HGB Lyse Once installed reagent on the instrument, is stable
for 60 days.
INTENDENT USE DO NOT use reagent once frozen.
For In Vitro Diagnostic Use Only
Neo-WIC/HGB Lyse is a reagent for lyse blood cells EXPECTED RESULTS
and determine hemoglobin on Cell Dyn3000, 3500, 3700. Performance should be within instrument
It is designed for use with Neo-Diluent CD5 and Neo- specification.
Sheath manufacturer Neomedica.
LIMITATIONS
SUMMARY & PRINCIPLE Reagent has to be used within the ambient
A sample volume of a whole blood specimen is temperature range of 15°C-30°C.
aspirated into the analyzer where a portion of it is NeoMedica reagents can be only used with other
automatically diluted with Neo-Diluent CD5, then NeoMedica reagents. If the reagent is mixed with third
introduced into flow cytometer where RBC and PLT is party reagents, incorrect results may be obtained.
measured. Blood specimens for hematological analysis may be
To the remainder of the first dilution a lysing reagent stored for up to 8 hours at 15°C-30°C or up to 24
Neo-WIC/HGB Lyse is added for the measurement hours after collection when refrigerated 2°C-8°C.
hemoglobin (HGB), and white blood cell (WBC), By taking samples from the fridge, they must be
lymphocytes (LYM), monocyte cell (MONO), eosinophil equal to room temperature with constant stirring
cell (EO) Basophil (BASO) and neutrophil cell (NEU)
measurement in the flow cytometer. MATERIALS REQUIRED BUT NOT PROVIDED
Consult your specific instrument Operator’s Manual for
additional information with respect to procedures and Cell Dyn 3000, 3500, 3700..
principles for whole blood hematological analysis.
• Neo-Diluent CD5
ACTIVE INGRIDIENTS Cat.No. / REF N12145 20 L- cubitainer
Quaternary Ammonium Salt ≤ 4.0 % • Neo-Sheath
Surfactant ≤ 0.2 % Cat.No. / REF N12164 10L – cubitainer
Cat.No. / REF N12165 20L – cubitainer
PRECAUTIONS
Only for professional use.
Before use, please read Operator's manual of the MANUFACTURER
instrument carefully. NeoMedica d.o.o.
Don't freeze. Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
Do not use reagents beyond the expiration date printed tel:+381 18 573822 fax:+381 18 573616
on the label email: ivd@neomedica.rs www.neomedica.rs
Use within 60 days after opening the reagent.
Don't ingest. Avoid skin and eyes contact.
In case of contact, rinse with plenty of water immediately.
Seek medical advice immediately in case of ingestion Wellkang Ltd t/a Wellkang Tech Consulting
and / or eyes contact. LONDON W1G 9QR, UK
Use Good Laboratory Practices when handling these
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE
• Person installing the reagents must be a trained
laboratory professional, versed for Abbott hematology
analyzers.
manual)
Version 16
1/1
Neo-Sheath 4 Package insert

WHOLE BLOOD SHEATH REAGENT
EXPECTED RESULTS
PRODUCT NAME Performance should be within instrument
Neo- Sheath specification.
Cat.No. / REF N12164 10 L- cubitainer
Cat.No. / REF N12165 20 L- cubitainer LIMITATIONS
Reagent has to be used within the ambient
INTENDENT USE temperature range of 15°C-30°C.
For In Vitro Diagnostic Use Only NeoMedica reagents can be only used with other
NeoMedica reagents. If the reagent is mixed with third
Neo-Sheath is sample blood diluting reagent, used for party reagents, incorrect results may be obtained.
WBC counting and differentiation in WOC channel of
Abbott Cell-Dyn 3500 and 3700 automated hematology MATERIALS REQUIRED BUT NOT PROVIDED
analyzers. Automated Hematology Analyzer (Cell Counter)
Intended for use in a set NeoMedica. Abbott CD3500 or 3700 .
Neomedica set reagents.
ACTIVE INGRIDIENTS SPECIMEN REQUIREMENTS

Buffering Agents ≤ 1.0 % Blood specimens for hematological analysis may be
Non ion surfactant ≤ 0.1 % stored for up to 8 hours at 15°C-30°C or up to 24
Stabilization Agents ≤ 0.55 % hours after collection when refrigerated 2°C-8°C.
By taking samples from the fridge, they must be
PRECAUTIONS equal to room temperature with constant stirring
• Only for professional use.
• Before use, please read Operator's manual of the MANUFACTURER
• Don't freeze. Bul. Sv.Cara Konstantina 82-86, 18000 Nis, Serbia
• Do not use reagents beyond the expiration date tel:+381 18 573822 fax:+381 18 573616
printed on the label. email: ivd@neomedica.rs www.neomedica.rs
• Before use, check the package for signs of damage.
• Use within 60 days after opening the reagent. Suite B, 29 Harley Street,
• Don't ingest. Avoid skin and eyes contact. LONDON W1G 9QR, UK
• In case of contact, rinse with plenty of water
immediately.
• Seek medical advice immediately in case of ingestion
and / or eyes contact.
• Use Good Laboratory Practices when handling these
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for Abbott Hematology
Analyzer.
• Leave the reagents at room temperature (15°C-30°C)
for at least 24 hours.
manual)
• When installing a new LOT of reagents recalibrate the
instrument (Operator's manual)
STORAGE & STABILITY

The reagent has an unopened stability of 18 months
from date of manufacture when stored at 5°C-30°C. See
package label for expiry date.
for 60 days.
Version 16 SREN
1/1
Package insert
Neo-Diluent/Sheath 5

WHOLE BLOOD DILUTING REAGENT
STORAGE & STABILITY
PRODUCT NAME The reagent has an unopened stability of 18
Neo-Diluent / Sheath months from date of manufacture when stored at 5°C-
Cat.No. / REF N12125 20 L- cubitainer 30°C. See package label for expiry date.
INTENDENT USE for 60 days.
For In Vitro Diagnostic Use Only DO NOT use reagent once frozen.
This diluent is necessary for the process involved in EXPECTED RESULTS
counting (and differentiating) the blood cells. Neo-Diluent / Performance should be within instrument
Sheath is Reagents for Automated Hematology Analyzer specification.
Abbott CD3200.
Intended for use in a set NeoMedica, with Neo-WBC Lyse LIMITATIONS
and Neo-HGB/NOC Lyse Reagent has to be used within the ambient
A sample volume of a whole blood specimen is NeoMedica reagents. If the reagent is mixed with third
aspirated into the analyzer where a portion of it is party reagents, incorrect results may be obtained.
automatically diluted with Neo-Diluent/Sheath.
Dilution of the sample is then introduced into Flow MATERIALS REQUIRED BUT NOT PROVIDED
cytometer analyzer where the red blood cell count (RBC) Automated Hematology Analyzer (Cell Counter)
and the thrombocyte count (PLT) is measured. Abbott CD3200 .
Consult your specific instrument Operator’s Manual for • Neo-WBC Lyse
additional information with respect to procedures and Cat.No. / REF N12212 1 L- bottle
principles for whole blood hematological analysis. • Neo-HGB/NOC Lyse
Cat.No. / REF N12223 3.8 L- cubitainer
ACTIVE INGRIDIENTS
Sodium sulfate Anhydrous ≤ 1.0 % SPECIMEN REQUIREMENTS
Anti-Microbial Agents ≤ 0.15 % Blood specimens for hematological analysis may be
Buffering Agents ≤ 0.4 % stored for up to 8 hours at 15°C-30°C or up to 24
hours after collection when refrigerated 2°C-8°C.
PRECAUTIONS By taking samples from the fridge, they must be
• Only for professional use. equal to room temperature with constant stirring
instrument carefully. MANUFACTURER
• Don't freeze. NeoMedica d.o.o.
• Do not use reagents beyond the expiration date printed Bul. Sv.Cara Konstantina 82-86, 18000 Nis, Serbia
on the label. tel:+381 18 573822 fax:+381 18 573616
• Before use, check the package for signs of damage. email: ivd@neomedica.rs www.neomedica.rs
• Don't ingest. Avoid skin and eyes contact. Wellkang Ltd t/a Wellkang Tech Consulting
• In case of contact, rinse with plenty of water immediately. LONDON W1G 9QR, UK
reagents.
PERSONAL PROTECTION
Safety glasses and laboratory gloves are recommended.
INSTRUCTION FOR USE

Person installing the reagents must be a trained laboratory
professional, versed for Abbott Hematology Analyzer.
• Leave the reagents at room temperature (15°C-30°C) for
at least 24 hours.
manual)
Version 16 SREN
1/1
Neo-WBC-Lyse 6 Package insert

(Operator's manual)
This reagent is used to lyse blood cells . • When installing a new LOT of reagents
recalibrate the instrument (Operator's manual)
Cat.No. / REF N12212 1 L- bottle
PRODUCT NAME
Neo-WBC-Lyse 30°C. See package label for expiry date.
Neo-WBC-Lyse is a reagent for lyse blood cells and
determine WBC, Lymphocyte, monocyte, eosinophil, EXPECTED RESULTS
basophil and neutrophil on Cell Dyn3200. Performance should be within instrument
It is designed for use with Neo-Diluent / Sheath and specification.
Neo HGB/NOC Lyse manufacturer Neomedica.
LIMITATIONS
automatically diluted with Neo-Diluent / Sheath, then NeoMedica reagents. If the reagent is mixed with third
introduced into flow cytometer wher RBC and PLT is party reagents, incorrect results may be obtained.
Neo-HGB/NOC Lyse is added for the measurement hours after collection when refrigerated 2°C-8°C.
hemoglobin (HGB). By taking samples from the fridge, they must be
A third portion of blood sample is diluted with the Neo equal to room temperature with constant stirring
WBC-Lyse and white blood cell (WBC), lymphocytes
(LYM), monocyte cell (MONO), eosinophil cell (EO) MATERIALS REQUIRED BUT NOT PROVIDED
Basophil (BASO) and neutrophil cell (NEU)
measurement in the flow cytometer.. Cell Dyn 3200.
additional information with respect to procedures and Neo-Diluent / Sheath
principles for whole blood hematological analysis. Cat.No. / REF N12125 20 L- cubitainer
ACTIVE INGRIDIENTS Neo-HGB / NOC Lyse
Quaternary Ammonium Salt ≤ 4.5 % Cat.No. / REF N12223 3.8 L- cubitainer
Surfactant ≤ 1.0 %
PRECAUTIONS MANUFACTURER
Only for professional use. NeoMedica d.o.o.
Before use, please read Operator's manual of the Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
instrument carefully. tel:+381 18 573822 fax:+381 18 573616
Don't freeze. email: ivd@neomedica.rs www.neomedica.rs
on the label
Don't ingest. Avoid skin and eyes contact. Suite B, 29 Harley Street,
In case of contact, rinse with plenty of water immediately. LONDON W1G 9QR, UK
Seek medical advice immediately in case of ingestion
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE
laboratory professional, versed for Abbot hematology
analyzers.
Version 16
1/1
Package insert
Neo-HGB/NOC Lyse 7
• When installing a new LOT of reagents

This reagent is used to lyse blood cells .
STORAGE & STABILITY
Cat.No. / REF N12223 3.8 L- cubitainer The reagent has an unopened stability of 24
PRODUCT NAME
30°C. See package label for expiry date.
Neo-HGB/NOC Lyse Once installed reagent on the instrument, is stable
for 60 days.
Neo-HGB/NOC Lyse is a reagent for lyse blood cells EXPECTED RESULTS
and determine hemoglobin on Cell Dyn3200. Performance should be within instrument
It is designed for use with Neo-Diluent / Sheath and specification.
Neo-WBC Lyse manufacturer Neomedica.
LIMITATIONS
automatically diluted with Neo-Diluent / Sheath, then NeoMedica reagents. If the reagent is mixed with third
introduced into flow cytometer where RBC and PLT is party reagents, incorrect results may be obtained.
Neo-HGB/NOC Lyse is added for the measurement hours after collection when refrigerated 2°C-8°C.
hemoglobin (HGB). By taking samples from the fridge, they must be
A third portion of blood sample is diluted with the Neo equal to room temperature with constant stirring
WBC-Lyse and white blood cell (WBC), lymphocytes
(LYM), monocyte cell (MONO), eosinophil cell (EO) MATERIALS REQUIRED BUT NOT PROVIDED
Basophil (BASO) and neutrophil cell (NEU)
measurement in the flow cytometer.. Cell Dyn 3200.
additional information with respect to procedures and Neo-Diluent / Sheath
principles for whole blood hematological analysis. Cat.No. / REF N12125 20 L- cubitainer
ACTIVE INGRIDIENTS Neo-WBC Lyse
Quaternary Ammonium Salt ≤ 5.0 % Cat.No. / REF N12223 1 L- bottle
Surfactant ≤ 3.0 %
PRECAUTIONS MANUFACTURER
Only for professional use. NeoMedica d.o.o.
Before use, please read Operator's manual of the Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
Don't freeze. email: ivd@neomedica.rs www.neomedica.rs
on the label
Don't ingest. Avoid skin and eyes contact. Suite B, 29 Harley Street,
In case of contact, rinse with plenty of water immediately. LONDON W1G 9QR, UK
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE
analyzers.
manual)
Version 16
1/1
Neo-Diluent CD3 8 Package insert
WHOLE BLOOD DILUTING REAGENT INSTRUCTION FOR USE

PRODUCT NAME laboratory professional, versed for Abbott Hematology
Neo-Diluent CD3 Analyzer.
Cat.No. / REF N12105 20 L- cubitainer • Leave the reagents at room temperature (15°C-
Cat.No. / REF N12103 5 L- cubitainer 30°C) for at least 24 hours.
INTENDENT USE MATERIALS REQUIRED BUT NOT PROVIDED)
For In Vitro Diagnostic Use Only • Prime the reagents through instruments (Operator's
manual)
This diluent is necessary for the process involved in • When installing a new LOT of reagents recalibrate
counting (and differentiating) the blood cells. Neo- the instrument (Operator's manual)
Diluent CD3 is Reagents for Automated Hematology
Analyzer Abbott CD1300, CD1400, CD1500, CD1600, STORAGE & STABILITY
CD1700, CD1800. The reagent has an unopened stability of 24
Intended for use in a set NeoMedica, with Neo-Lyse CD3
and Neo-Detergent CD3
30°C. See package label for expiry date.
SUMMARY & PRINCIPLE
for 60 days.
A sample volume of a whole blood specimen is
aspirated into the analyzer where a portion of it is
automatically diluted with Neo-DILUENT CD3.
EXPECTED RESULTS
Part of this first dilution is further diluted with the Neo-
Performance should be within instrument
DILUENT CD3 (second dilution). This second dilution of
specification.
the sample is then introduced into impedance particle
analyzer where the red blood cell count (RBC) and the
LIMITATIONS
thrombocyte count (PLT) is measured.
To the remainder of the first dilution a lysing reagent is
added for the measurement of hemoglobin (HGB), white
NeoMedica reagents can be only used with other
blood cell count (WBC), lymphocytes count (LYM), mid
cell (MID), granulocyte count (GRAN). Consult your
party reagents, incorrect results may be obtained.
specific instrument Operator’s Manual for additional
information with respect to procedures and principles for
MATERIALS REQUIRED BUT NOT PROVIDED
whole blood hematological analysis.
Automated Hematology Analyzer (Cell Counter)
Abbott CD1300, CD1400, CD1500, CD1600,
ACTIVE INGRIDIENTS
CD1700 and CD1800.
Sodium Chloride ≤ 0.5 %
Neo-Lyse CD3
Sodium sulfate Anhydrous ≤ 1.0 %
Anti-Microbial Agents ≤ 0.1 % Cat.No. / REF N12202 1 L- bottle
Buffer ≤ 0.1 % Neo-Detergent CD3
PRECAUTIONS Cat.No. / REF N12303 5 L- cubitainer
• Before use, please read Operator's manual of the SPECIMEN REQUIREMENTS
instrument carefully. Blood specimens for hematological analysis may be
• Don't freeze. stored for up to 8 hours at 15°C-30°C or up to 24
• Do not use reagents beyond the expiration date hours after collection when refrigerated 2°C-8°C.
printed on the label. By taking samples from the fridge, they must be
• Before use, check the package for signs of damage. equal to room temperature with constant stirring
immediately. Bul. Sv. Cara Konstantina 82-86,
• Seek medical advice immediately in case of ingestion 18000 Niš, Srbija
• Use Good Laboratory Practices when handling these email: ivd@neomedica.rs www.neomedica.rs
reagents.
PERSONAL PROTECTION LONDON W1G 9QR, UK
recommended.
Version 16 SREN
1/1
Neo-Detergent CD3 9 Package insert
STORAGE & STABILITY

Reagent for washing The reagent has an unopened stability of 18
Neo-Detergent CD3 30°C in a dark place. See package label for expiry
Cat.No. / REF N12305 20 L- cubitainer date.
Cat.No. / REF N12303 5 L- cubitainer Once installed reagent on the instrument, is stable
for 60 days.
PRODUCT NAME DO NOT use reagent once frozen.
Neo-Detergent CD3
EXPECTED RESULTS
INTENDENT USE Performance should be within instrument
For In Vitro Diagnostic Use Only specification.
Neo-Detergent CD3 is to be used to rinse CellDyn
1300, 1400, 1500, 1600, 1700 and Cell Dyn1800, LIMITATIONS
hematological analyzers between measurements and Reagent has to be used within the ambient
cleaning. temperature range of 15°C-30°C.
It is designed for use with Neo-Diluent CD3 and Neo- NeoMedica reagents can be only used with other
Lyse CD3 manufacturer Neomedica. NeoMedica reagents. If the reagent is mixed with third
SUMMARY & PRINCIPLE Blood specimens for hematological analysis may be
Neo-Detergent CD3 is a cleaning reagent that stored for up to 8 hours at 15°C-30°C or up to 24
effectively cleans out cell debris, proteins and hours after collection when refrigerated 2°C-8°C.
triglycerides by detergent solubilization. By taking samples from the fridge, they must be
equal to room temperature with constant stirring
ACTIVE INGRIDIENTS
Sodium sulphate anh. ≤ 1.0 % MATERIALS REQUIRED BUT NOT PROVIDED
Sodium hloride ≤ 0.6 % Cell Dyn1300, Cell Dyn 1400, Cell Dyn 1500, , Cell
Surfactant nonion ≤ 0.2 % Dyn 1600, Cell Dyn 1700, Cell Dyn1800.
Sodium hydroxide ≤ 0.01 %
Neo-Diluent-CD3
Only for professional use. • Neo-Lyse CD3
Before use, please read Operator's manual of the Cat.No. / REF N12203 5 L- cubitainer
instrument carefully. Cat.No. / REF N12202 1 L- bottle
Don't freeze.
on the label MANUFACTURER
Use within 60 days after opening the reagent. NeoMedica d.o.o.
Don't ingest. Avoid skin and eyes contact. Bul.Sv.Cara Konstantina 82-86, 18000 Nis,
In case of contact, rinse with plenty of water immediately. Serbia
Seek medical advice immediately in case of ingestion tel:+381 18 573822 fax:+381 18 573616
and / or eyes contact. email: ivd@neomedica.rs www.neomedica.rs
reagents.
PERSONAL PROTECTION
Safety glasses and laboratory gloves are Suite B, 29 Harley Street,
recommended. LONDON W1G 9QR, UK
INSTRUCTION FOR USE
• Person installing the reagets must be a trained
laboratory professional, versed for Abbott hematology
analyzers Cell Dyn series.
manual)
Version 16
1/1
Package insert
Neo-Lyse CD3 10
• Connect the other reagents to the instrument

This reagent is used to lyse blood cells and determine (see MATERIALS REQUIRED BUT NOT
hemoglobin concentration. PROVIDED)
Cat.No. / REF N12203 5 L- cubitainer (Operator's manual)
Cat.No. / REF N12202 1 L- bottle • When installing a new LOT of reagents
PRODUCT NAME
Neo-Lyse CD3 STORAGE & STABILITY
INTENDENT USE months from date of manufacture when stored at 5°C-
For In Vitro Diagnostic Use Only 30°C. See package label for expiry date.
Neo-Lyse CD3 is a reagent for lyse blood cells and Once installed reagent on the instrument, is stable
determine hemoglobin concentration in automated for 60 days.
hematology analyzers Abbott Cell Dyn 1300, Cell Dyn DO NOT use reagent once frozen.
1400, Cell Dyn 1500, Cell Dyn 1600, Cell Dyn 1700, Cell
Dyn1800. EXPECTED RESULTS
It is designed for use with Neo-Diluent CD3 and Neo Performance should be within instrument
Detergent CD3 manufacturer Neomedica. specification.
SUMMARY & PRINCIPLE LIMITATIONS

A sample volume of a whole blood specimen is Reagent has to be used within the ambient
aspirated into the analyzer where a portion of it is temperature range of 15°C-30°C.
automatically diluted with Neo-DILUENT CD3. NeoMedica reagents can be only used with other
Part of this first dilution is further diluted with the Neo- NeoMedica reagents. If the reagent is mixed with third
DILUENT CD3 (second dilution). This second dilution of party reagents, incorrect results may be obtained.
the sample is then introduced into impedance particle Blood specimens for hematological analysis may be
analyzer where the red blood cell count (RBC) and the stored for up to 8 hours at 15°C-30°C or up to 24
thrombocyte count (PLT) is measured. hours after collection when refrigerated 2°C-8°C.
To the remainder of the first dilution a lysing reagent is By taking samples from the fridge, they must be
added for the measurement of hemoglobin (HGB), white equal to room temperature with constant stirring
blood cell count (WBC), lymphocytes count (LYM), mid
cell (MID), granulocyte count (GRAN). Consult your MATERIALS REQUIRED BUT NOT PROVIDED
specific instrument Operator’s Manual for additional Cell Dyn1300, Cell Dyn 1400, Cell Dyn 1500, Cell
information with respect to procedures and principles for Dyn 1600, Cell Dyn 1700, Cell Dyn1800.
whole blood hematological analysis.
• Neo-Diluent-CD3
ACTIVE INGRIDIENTS Cat.No. / REF N12105 20 L- cubitainer
Quaternary Ammonium Salt ≤ 3.8 %
Surfactant ≤ 0.1 % • Neo-Detergent CD3
Before use, please read Operator's manual of the
Don't freeze. NeoMedica d.o.o.
Do not use reagents beyond the expiration date printed Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
on the label tel:+381 18 573822 fax:+381 18 573616
Use within 60 days after opening the reagent. email: ivd@neomedica.rs www.neomedica.rs
and / or eyes contact. Wellkang Ltd t/a Wellkang Tech Consulting
Use Good Laboratory Practices when handling these LONDON W1G 9QR, UK
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE
analyzers.
Version 16
1/1
Neo-EZ-Cleaner 11
SOLUTION FOR DAILY MAINTENANCE
Cat.No. / REF N 12400 Bottle 50 ml

STORAGE & STABILITY
PRODUCT NAME Unopened reagent has stability of 12 months from
Neo-EZ-Cleaner date of manufacture when stored at 5°C- 30°C. See
INTENDENT USE Once installed reagent on the instrument, is stable for
For In Vitro Diagnostic Use Only. 60 days.
Neo-EZ-Cleaner is solution for periodic - daily cleaning Do not use reagent wich was on temperature lower
automated hematology analyzers Abbott CD1300, than 2º C ( or reagent wich was frozen).
CD1400, CD1700, CD1800, CD3000, CD3200, CD3500,
EXPECTED RESULTS
CD3700..
SUMMARY & PRINCIPLE specification.
See instruction for your specific analyzer if you want
more informations. LIMITATIONS AND SPECIAL REQUEST
Recommendation is to use solution only for
ACTIVE INGRIDIENTS automated hematology analyzers Abbott CD1300,
CD1400, CD1700, CD1800, CD3000, CD3200,
Proteolitic enzym ≤ 0.8 %
CD3500, CD3700..
Sodium hlorid ≤ 0.5 %
Nonionic surfactants ≤ 0.15 %
Buffering Agents ≤ 0.4 % PROIZVOĐAČ
Antifung. & Antibact. agents ≤ 0.25% NeoMedica d.o.o.
Bul. Sv. Cara Konstantina 82-86, 18000 Niš, Srbija
tel:+381 18 573822 fax:+381 18 573616
PRECAUTIONS
email: ivd@neomedica.rs www.neomedica.rs
instrument carefully. Wellkang Ltd t/a Wellkang Tech Consulting
• Don't freeze. Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
• Don’t shake.
• Do not use reagents beyond the expiration date
printed on the label.
• Don't ingest. Avoid skin and eyes contact. In case of
contact, rinse with plenty of water immediately.
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional hematology analyzer Abbott.
manual)
V16
2/2
Neo-Diluent- M 12 Package insert
60, OT16, OT18 and BAYER Advia 60

WHOLE BLOOD DILUTING REAGENT Haematology Analyzer.
 Leave the reagents at room temperature (15C-
Cat.No. / REF N 13104 10 L- cubitainer 30C) for at least 24 hours.
Cat.No. / REF N 13114 10 L- canister  Connect the other reagents to the instrument (see
Cat.No. / REF N 13105 20 L-cubitainer MATERIALS REQUIRED BUT NOT PROVIDED)
 Prime the reagents through instruments (Operator's
PRODUCT NAME manual)
Neo-Diluent -M  When installing a new LOT of reagents recalibrate
INTENDENT USE
For In Vitro Diagnostic Use Only STORAGE & STABILITY
Neo-Diluent M is Reagents for Automated Haematology The reagent has an unopened stability of 15
Analyzer - diluent (dilute the blood sample). It is desgned
months from date of manufacture when stored at 5C-
for ABX Micros 45 and 60, OT16, OT18, BAYER Advia
30C. See package label for expiry date.
60 and Horiba LC550.
Once installed reagent on the instument, is stable
 Intended for use in a set NeoMedica, with Neo-
for 60 days.
Cleaner-M and Neo-M-Lyse
SUMMARY & PRINCIPLE
EXPECTED RESULTS
Dilutions are prepared for whole blood to disperse the
cells so that, in most cases, the cells pass through the
specification.
aperture individually. Also in this way, the conductive
environment for cell counting and sizing is available. LIMITATIONS
The diluted specimens are aspirated into the RBC and
WBC apertures under a negative pressure.
temperature range of 15C-30C.
White Blood Cell, Red Blood Cell and Platelet are
counted and sized by the Electrical Impedance Method.
This method is based on the measurement of changes in
electrical resistance produced by a particle passing
through an aperture.
Consult your specific instrument Operator's manual for
additional information.
 Automated Haematology Analyzer (Cell Counter)
ACTIVE INGRIDIENTS ABX Micros 45 and 60, OT16, OT18, BAYER Advia
60 and Horiba LC550.
Sodium Sulphate Anhydrous  1.0 %
 Neo-Cleaner-M
Sodium Chloride  0.5 %
 Neo-M-Lyse
Buffering Agents  0.2 %
Anti-Microbial Agents  0.25 % SPECIMEN REQUIREMENTS
Blood specimens for hematological analysis may be
PRECAUTIONS
stored for up to 8 hours at 15C-30C or up to 24
 Only for professional use.
hours after collection when refrigerated 2C-8C.
 Before use, please read Operator's manual of the
instrument carefully.
 Don't freeze.
 Do not use reagents beyond the expiration date METHOD FOR CLEANING UP
printed on the label. If any apsorbent material are used.. Clean with plenty
 Baefore use, check the package for signs of damage. water.
 Use within 60 days after opening the reagent.
 Don't ingest. Avoid skin and eyes contact. MANUFACTURER
 In case of contact, rinse with plenty of water NeoMedica d.o.o.
immediately. Bul.Sv Cara Konstantina 82-86, 18000 Niš, Srbija
 Seek medical advice immediately in case of ingestion tel:+381 18 573822 fax:+381 18 573616
 Use Good Laboratory Practices when handling these
reagents.
PERSONAL PROTECTION Suite B, 29 Harley Street,
Safety glasses and laboratory gloves are LONDON W1G 9QR, UK
recommended.
INSTRUCTION FOR USE

 Person installing the reagets must be a trained
laboratory professional, versed for ABX Micros 45 and
Version 2.1 SREN

Neo-M-Lyse 13
REAGENT FOR LYSIS OF ERYTHROCYTES

PACKAGE INSERT
Cat.No. / REF N 13202 1 l bottle
Cat.No. / REF N 13201 0.5 l bottle STORAGE & STABILITY
PRODUCT NAME 30C. See package label for expiry date.
Neo-M-Lyse Once installed reagent on the instument, is stable
for 60 days.
EXPECTED RESULTS
Neo-M-Lyse is a reagent for lysis of erythrocytes in Performance should be within instrument
automāted hematology analyzers. Designed for the ABX specification.
Micros 45 and 60, OT 16, OT 18, BAYER Advia 60 and
Horiba LC550. LIMITATIONS
It is designed for use in the kit Neomedica, with Neo- Reagent has to be used within the ambient
Diluent-M and Neo-Cleaner-M temperature range of 15C-30C.
PRINCIPLE NeoMedica reagents. If the reagent is mixed with third
White Blood Cell, Red Blood Cell and Platelet are party reagents, incorrect results may be obtained.
counted and sized by the Electrical Impedance Method. Blood specimens for hematological analysis may be
This method is based on the measurement of changes in stored for up to 8 hours at 15C-30C or up to 24
electrical resistance produced by a particle passing hours after collection when refrigerated 2C-8C.
through an aperture. By taking samples from the fridge, they must be
Consult your specific instrument Operator's manual for equal to room temperature with constant stirring
ACTIVE INGREDIENTS Haematology Analyzer (Cell Counter) ABX Micros 45
Quaternary Ammonium Salt  3.5 % and 60, OT 16, OT 18 and BAYER Advia 60.
Surfactant  0.5 %
Buffer  0.5 %  Neo-Cleaner-M
Cat.No. / REF N13302 1 L- bottle
PRECAUTIONS
 Only for professional use.  Neo-Diluent-M
 Before use, please read Operator's manual of the Cat.No. / REF N13105 20 L- cubitainer
 Don't freeze.
 Do not use reagents beyond the expiration date
printed on the label
 Use within 60 days after opening the reagent. MANUFACTURER
 Don't ingest. Avoid skin and eyes contact. NeoMedica d.o.o.
 In case of contact, rinse with plenty of water Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
immediately. tel:+381 18 573822 fax:+381 18 573616
 Seek medical advice immediately in case of ingestion
 Use Good Laboratory Practices when handling these Wellkang Ltd t/a Wellkang Tech Consulting
reagents. Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE
Person installing the reagets must be a trained laboratory
professional, versed for ABX Micros 45 and 60, OT 16,
OT 18 BAYER Advia 60 and Horiba LC550.
hematology analyzers.
 Leave the reagents at room temperature (15C-30C)
 Connect the other reagents to the instrument (see
manual)
 When installing a new LOT of reagents recalibrate the
Version 2.1
2/2
Neo-Cleaner-M 14
Reagent for washing

STORAGE & STABILITY
Cat.No. / REF N 13302 1 L- bottle Unopened reagent has stability of 24 months from
Cat.No. / REF N 13301 0.5 L- boca date of manufacture when stored at 5C-30C. See
Once installed reagent on the instument, is stable for
PRODUCT NAME
60 days.
Neo-Cleaner-M Do not use reagent wich was on temperature lower
than 5º C ( or reagent wich was frozen).
INTENDENT USE
For In Vitro Diagnostic Use Only. EXPECTED RESULTS
Neo-Cleaner-M is reagent for washing tubing system Performance should be within instrument
of automated haematology analyzers ABX Micros 45 and specification.
60 , OT 16, OT 18 and BAYER Advia 60.
It is designed for use in the kit Neomedica, with Neo- LIMITATIONS
Diluent-M, Neo-M-Lyse Reagent has to be used within the ambient
METHOD PRINCIP NeoMedica reagents can be only used with other
This reagent is necessary for the Washung of Protein
NeoMedica reagents. If you use reagent Neo-
buildup from the Counting Apertures and Chambers
Cleaner M with reagents other manufacturers
ACTIVE INGREDIENTS you can expect wrong results.
Surfactant  0.5 % Blood specimens for hematological analysis may be
Proteolytic enzyme  0.5 % stored for up to 8 hours at 15C-30C or up to 24
Sodium chloride  1.0 % hours after collection when refrigerated 2C-8C.
By taking samples from the fridge, they must be equal
PRECAUTIONS to room temperature with constant stirring.
REQUIRED REAGENTS WITH WICH IT IS USED
 Neo-M-Lyse
 Don't freeze.
Cat.No. / REF N13202
 Don”t shake.
 Do not use reagents beyond the expiration date  Neo-Diluent –M
printed on the label. Cat.No. / REF N 13 105 20 L-cubitainer
 Don't ingest. Avoid skin and eyes contact. In case of
contact, rinse with plenty of water immediately. MANUFACTURER
 Seek medical advice immediately in case of ingestion NeoMedica d.o.o.
and / or eyes contact. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
 Use Good Laboratory Practices when handling these tel:+381 18 573822 fax:+381 18 573616
reagents. email: ivd@neomedica.rs www.neomedica.rs
PERSONAL PROTECTION
Safety glasses and laboratory gloves are Wellkang Ltd t/a Wellkang Tech Consulting
recommended. Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
INSTRUCTION FOR USE
laboratory professional, versed for ABX Micros 45 and
60, OT 16, OT 18, BAYER Advia 60 and Horiba LC550
manual)
PL/PI 015
Version 2.2
2/2
Neo-Cleaner-C 15 Package insert
Solution for maintenance and cleaning. Once installed reagent on the instument, is stable
for 60 days.
Cat.No. / REF N 13401 500 ml Bottle DO NOT use reagent once frozen.
Cat.No. / REF N 13402 1 L Bottle
EXPECTED RESULTS
Neo-Cleaner-C specification.
INTENDENT USE LIMITATIONS

For In Vitro Diagnostic Use Only Reagent has to be used within the ambient
Neo-Cleaner-C is solution for periodic cleaning needle temperature range of 15C-30C.
and systems of automated hematology analyzers
Micros 45 and 60, OT16 , OT18, Advia 60, Horiba
LC550, Pentra 60, Pentra 80, Pentra 120, hematology MANUFACTURER
analyzers. NeoMedica d.o.o.
Bul.Sv.Cara Konstantina 82-86, 18000 Nis, Serbia
SUMMARY & PRINCIPLE tel:+381 18 573822 fax:+381 18 573616
Neo-Cleaner-C is a hypochlorite cleaning reagent that email: ivd@neomedica.rs www.neomedica.rs
effectively cleans out cell debris, proteins and
triglycerides by oxidative digestion and detergent
solubilization. Wellkang Ltd t/a Wellkang Tech Consulting
Consult your specific instrument Operator’s Manual for Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
additional information with respect to procedures and
principles for whole blood hematological analysis.
ACTIVE INGRIDIENTS
Sodium hipohlorat  6.0 %
Sodium hidroksid  1.0 %
PRECAUTIONS
Before use, please read Operator's manual of the
Don't freeze.
on the label
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE
 Person installing the reagets must be a
trained laboratory professional, versed for ABX
hematology analyzers
 Leave the reagents at room temperature
(15C-30C) for at least 24 hours.
 Connect the other reagents to the instrument
(see MATERIALS REQUIRED BUT NOT PROVIDED)
 Prime the reagents through instruments
(Operator's manual)
 When installing a new LOT of reagents
STORAGE & STABILITY

from date of manufacture when stored at 5C-30C. See
Version 2.1
02.2013
1/1
16
Neo-Lyse NK PACKAGE INSERT
REAGENT FOR LYSIS OF ERYTHROCYTES EXPECTED RESULTS

Cat.No. / REF N110201 0.5 L-bottle specification.
LIMITATIONS
PRODUCT NAME Reagent has to be used within the ambient
Neo-Lyse NK temperature range of 15C-30C.
INTENDENT USE NeoMedica reagents. If the reagent is mixed with third
For In Vitro Diagnostic Use Only party reagents, incorrect results may be obtained.
Neo-Lyse NK is a reagent for lysis of erythrocytes in stored for up to 8 hours at 15C-30C or up to 24
automated hematology analyzers. Designed for the hours after collection when refrigerated 2C-8C.
Nihon Kohden MEK-8222, MEK-7222. By taking samples from the fridge, they must be
It is designed for use in the kit Neomedica, with Neo- equal to room temperature with constant stirring
Diluent NK, Neo-Rinse NK and Neo-Lisis NK.
ACTIVE INGRIDIENTS Hematology Analyzer Nihon Kohden MEK-8222,
Quaternary Ammonium Salts  4.5 % MEK-7222.
Nonion surfactant  1.0%
 Neo-Diluent NK
 Only for professional use.  Neo-Rinse NK
 Before use, please read Operator's manual of the Cat.No. / REF N110303 5 L- cubitainer
instrument carefully.  Neo-Lisis NK
 Don't freeze. Cat.No. / REF N110211 0.5 L- boca
 Do not use reagents beyond the expiration date  Neo-Cleanac NK
printed on the label Cat.No. / REF N110403 5 L- cubitainer
 Don't ingest. Avoid skin and eyes contact.
 In case of contact, rinse with plenty of water
immediately.
 Seek medical advice immediately in case of
ingestion and / or eyes contact. MANUFACTURER
 Use Good Laboratory Practices when handling NeoMedica d.o.o.
these reagents. Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
tel:+381 18 573822 fax:+381 18 573616
PERSONAL PROTECTION
Safety glasses, laboratory gloves and laboratory coat Wellkang Ltd t/a Wellkang Tech Consulting
are recommended. Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
INSTRUCTION FOR USE

laboratory professional, versed for Nihon Kohden
hematology analyzer.
30C) for at least 24 hours.
manual)
 When installing a new LOT of reagents recalibrate
STORAGE & STABILITY

from date of manufacture when stored at 5C-30C. See
Once installed reagent on the instrument, is stable for
60 days.
Version 2.1 SREN

03.2013
Neo-Lysis NK 17 PACKAGE INSERT
EXPECTED RESULTS
Lysing reagent for lysis of erythrocytes Performance should be within instrument
specification.
PRODUCT NAME
Neo-Lysis NK LIMITATIONS
Cat.No. / REF N110211 0.5 L- bottle temperature range of 15C-30C.
NeoMedica reagents. If you use reagent Neo-Lysis
INTENDENT USE NK with reagents other manufacturers you can
For In Vitro Diagnostic Use Only. expect wrong results.
Neo-Lysis NK is a reagent for lysis of erythrocytes in Blood specimens for hematological analysis may be
NIHON KOHDEN automated hematology analyzers. stored for up to 8 hours at 15C-30C or up to 24
INSTRUMENTS By taking samples from the fridge, they must be equal
It is designed for Nihon Kohden MEK-8222, 8118, 7222, to room temperature with constant stirring
6318, 6410 and 6400 hematology analysers.
ACTIVE INGRIDIENTS
Quaternary Ammonium Salts  5.0 % MANUFACTURER
NeoMedica d.o.o.
PRECAUTIONS tel:+381 18 573822 fax:+381 18 573616
 Only for professional use. email: ivd@neomedica.rs www.neomedica.rs
instrument carefully. Wellkang Ltd t/a Wellkang Tech Consulting
 Don't freeze. Suite B, 29 Harley Street,
 Do not use reagents beyond the expiration date LONDON W1G 9QR, UK
 Before use, check the package for signs of damage.
immediately.
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for NIHON KOHDEN
MATERIALS REQUIRED WITH WICH IS IT USED)
manual)
STORAGE & STABILITY

Unopened reagent has stability of 18 months from date
of manufacture when stored at 5C-30C. See package
label for expiry date.
Once installed reagent on the instrument, is stable for 60
days.
Do not use reagent wich was on temperature lower than
5º C ( or reagent wich was frozen).
Version 2.1 SREN

Neo-Rinse NK 18 PACKAGE INSERT
REAGENT FOR CLEANING/EMERGENCY CLEANING TF3.06 077.005
PRODUCT NAME  When installing a new LOT of reagents recalibrate

Neo-Rinse NK the instrument (Operator's manual)
Cat.No. / REF N110303 5 L- cubitajner STORAGE & STABILITY
Unopened reagent has stability of 12 months from
INTENDENT USE date of manufacture when stored at 5C-30C. See
For In Vitro Diagnostic Use Only package label for expiry date.
Neo-Rinse NK is to be used to Cleaning or Emergency Once installed reagent on the instrument, is stable for
cleaning NIHON KOHDEN hematological analyzers 60 days.
between measurements. Do not use reagent wich was on temperature lower
INSTRUMENTS
It is designed for cleaning NIHON KOHDEN MEK-8222, EXPECTED RESULTS
8118, 7222, 6318 hematology analysers. Performance should be within instrument
It is for Emergency cleaning for Nihon Kohden MEK- specification.
6108, 6400, 6410 hematology analysers.
LIMITATIONS
Neo-Rinse NK is a cleaning reagent that effectively temperature range of 15C-30C.
cleans out cell debris, proteins and triglycerides by NeoMedica reagent can only be used with other
detergent solubilization. NeoMedica reagents. If you use reagent Neo-Rinse
NK with reagents other manufacturers you can
ACTIVE INGRIDIENTS
expect wrong results.
Sodium hypochlorite ≤ 1.0 %
Sodium hydroxide  1.0 %
PRECAUTIONS
to room temperature with constant stirring
 Don't freeze. NeoMedica d.o.o.
 Do not use reagents beyond the expiration date Bul. Sv. Cara Konstantina 82-86, 18000 Niš, Srbija
printed on the label. tel:+381 18 573822 fax:+381 18 573616
 Before use, check the package for signs of damage. email: ivd@neomedica.rs www.neomedica.rs
 In case of contact, rinse with plenty of water Suite B, 29 Harley Street,
immediately. LONDON W1G 9QR, UK
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

manual)
Version V2.1 SREN

Neo-Diluent-ST 19
STORAGE & STABILITY

Cat.No. / REF N16105 20 L cubitainer The reagent has an unopened stability of 15
PRODUCT NAME 30C. See package label for expiry date.
Neo-Diluent - ST Once installed reagent on the instument, is stable
for 60 days.
EXPECTED RESULTS
Neo-Diluent-ST is Reagents for Automated Performance should be within instrument
Haematology Analyzer - (dilute the blood sample). specification.
It is desgned for Sysmex KX-21,KX-21N, POCH-100i,
K-100, XT-1800i, XT-2000i i SF-3000. LIMITATIONS
Intended for use with Neo-Lyser –WH i Neo CelN- Reagent has to be used within the ambient
Cleaner. temperature range of 15C-30C.
SUMMARY & PRINCIPLE NeoMedica reagents. If the reagent is mixed with third
White Blood Cell, Red Blood Cell and Platelet are party reagents, incorrect results may be obtained.
This method is based on the measurement of changes in MATERIALS REQUIRED BUT NOT PROVIDED
electrical resistance produced by a particle passing Automated Haematology Analyzer (Cell Counter)
through an aperture. Sysmex KX-21, KX-21N, POCH-100i, K-100,
Consult your specific instrument Operator's manual for XT-1800i, XT-2000i i SF-3000.
 Neo-Lyser –WH
ACTIVE INGRIDIENTS
N Cat.No. / REF N 16201 - 0.5 l bottle
Sodium Sulphate Anhydrous  1.0 %
Buffering Agents  0.2 %  Neo CelN-Cleaner
Anti-Microbial Agents  0.1 % Cat.No. / REF N16400 50 ml -bottle
PRECAUTIONS
 Only for professional use. SPECIMEN REQUIREMENTS
 Before use, please read Operator's manual of the Blood specimens for hematological analysis may be
instrument carefully. stored for up to 8 hours at 15C-30C or up to 24
 Don't freeze. hours after collection when refrigerated 2C-8C.
 Do not use reagents beyond the expiration date By taking samples from the fridge, they must be
printed on the label. equal to room temperature with constant stirring
 Baefore use, check the package for signs of damage.
immediately. MANUFACTURER
 Seek medical advice immediately in case of ingestion NeoMedica d.o.o.
and / or eyes contact. Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
 Use Good Laboratory Practices when handling these tel:+381 18 573822 fax:+381 18 573616
reagents. email: ivd@neomedica.rs www.neomedica.rs
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE LONDON W1G 9QR, UK
laboratory professional, versed for Sysmex
Haematology Analyzer.
manual)
Version 2.0 SRP/ENG
1/1
PACKAGE INSERT
Neo-SLS Lyser 20
REAGENT FOR LYSIS OF ERYTHROCYTES EXPECTED RESULTS

Cat.No. / REF N16281 0.5 L-bottle specification.
Cat.No. / REF N16282 5 L-cubitainer
LIMITATIONS
PRODUCT NAME temperature range of 15°C-30°C.
Neo-SLS Lyser NeoMedica reagents can be only used with other
INTENDENT USE party reagents, incorrect results may be obtained.
For In Vitro Diagnostic Use Only Blood specimens for hematological analysis may be
Neo-SLS Lyser is lysing solution for determination of hours after collection when refrigerated 2°C-8°C.
HGB in blood on na Sysmex XT-1800i, XT-200i, XE- By taking samples from the fridge, they must be
2100, XS-800i, XS-1000i and SF-3000 hematology equal to room temperature with constant stirring
analyzers.
It is designed for use in the Neomedica set reagents.
ACTIVE INGRIDIENTS MANUFACTURER

Sodium dodecyl sulfate ≤ 0.2 % NeoMedica d.o.o.
Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
• Only for professional use. email: ivd@neomedica.rs www.neomedica.rs
• Don't freeze. Wellkang Ltd t/a Wellkang Tech Consulting
• Do not use reagents beyond the expiration date LONDON W1G 9QR, UK
• Don't ingest. Avoid skin and eyes contact.
immediately.
reagents.
PERSONAL PROTECTION
Safety glasses, laboratory gloves and laboratory coat
are recommended.
INSTRUCTION FOR USE

laboratory professional, versed for SYSMEX hematology
analyzer.
manual)
STORAGE & STABILITY

60 days.
Version 16 SREN
Neo-FB-Lyser 21 PACKAGE INSERT
Lysing solution for Basophil count and WBC total count

TF3.06 040.003
076.003
PRODUCT NAME
Neo-FB-Lyser STORAGE & STABILITY
Cat.No. / REF N16283 5 L- cubitainer date of manufacture when stored at 5C-30C. See
Neo-FB-Lyser is a lyse reagent for determination of Do not use reagent wich was on temperature lower
WBC and Basophils on SYSMEX automated hematology than 5º C ( or reagent wich was frozen).
analyzers.
It is designed for SYSMEX XT-1800i, XT-2000i, XE-2100
and SYSMEX SF-3000 hematology analysers.
EXPECTED RESULTS
PRINCIPLE Performance should be within instrument
Neo-FB-Lyser lyses red blood cells and eliminates specification.
White blood cell stroma other then Basophil to count and
size Basophil, and to determine WBC total count. The LIMITATIONS
denucleated White cells will be shunken to be smaller Reagent has to be used within the ambient
than other blood cells. temperature range of 15C-30C.
Consult your specific instrument Operator's manual for NeoMedica reagents can be only used with other
additional information. NeoMedica reagents. If you use reagent Neo-FB-
Lyser with reagents other manufacturers you can
ACTIVE INGRIDIENTS expect wrong results.
Buffer  0.3 % Blood specimens for hematological analysis may be
Surfactant  0.6 % stored for up to 8 hours at 15C-30C or up to 24
Stabilizer  0.09 % hours after collection when refrigerated 2C-8C.
After taking samples from the fridge, they must be
PRECAUTIONS brought to room temperature with constant stirring
 Don't freeze. MANUFACTURER
 Do not use reagents beyond the expiration date NeoMedica d.o.o.
printed on the label. Bul.Sv.Cara Konstantina 82-86, Niš 18000, Serbia
 Before use, check the package for signs of damage. tel:+381 18 573822 fax:+381 18 573616
 Use within 60 days after opening the reagent. email: ivd@neomedica.rs www.neomedica.rs
 In case of contact, rinse with plenty of water Wellkang Ltd t/a Wellkang Tech Consulting
immediately. Suite B, 29 Harley Street,
 Seek medical advice immediately in case of ingestion LONDON W1G 9QR, UK
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

analyzers.
manual)
Version 2.0 SREN

1/1
Neo-4DN-Lyser 22 PACKAGE INSERT
Lysing solution for differential counting of WBC

PRODUCT NAME STORAGE & STABILITY
Neo-4DN-Lyser Unopened reagent has stability of 18 months from
date of manufacture when stored at 5C-30C. See
Cat.No. / REF N16263 5 L- cubitainer package label for expiry date.
INTENDENT USE 60 days.
For In Vitro Diagnostic Use Only. Do not use reagent wich was on temperature lower
Neo-4DN- Lyser is a lysing solution for sizing and than 5º C ( or reagent wich was frozen).
counting of white blood cells on SYSMEX automated
hematology analyzers. EXPECTED RESULTS
It is designed for SYSMEX XT-1800i, XT-2000i, XE- Performance should be within instrument
2100, XS-800i and XS-1000i hematology analysers. It specification.
has to be used in combination with Neo-4DS Lyser.
LIMITATIONS
PRINCIPLE Reagent has to be used within the ambient
Neo-4DN-Lyser used in combination with Neo-4DS- temperature range of 15C-30C.
Lyser, eliminates red blood cell stroma for accurate NeoMedica reagents can be only used with other
counting and sizing of the Lymphocytes, Monocytes, NeoMedica reagents. If you use reagent Neo-4DN-
Eosinophils and Neutrophils. Lyser with reagents other manufacturers you can
Consult your specific instrument Operator's manual for expect wrong results.
additional information. Blood specimens for hematological analysis may be
ACTIVE INGRIDIENTS hours after collection when refrigerated 2C-8C.
Buffer  2.0 % After taking samples from the fridge, they must be
Surfactant  10.0 % brought to room temperature with constant stirring
PRECAUTIONS
 Before use, please read Operator's manual of the MANUFACTURER
 Don't freeze. Bul. Sv. Cara Konstantina 82-86, 18000 Niš, Srbija
 Do not use reagents beyond the expiration date tel:+381 18 573822 fax:+381 18 573616
 Don't ingest. Avoid skin and eyes contact. Suite B, 29 Harley Street,
 In case of contact, rinse with plenty of water LONDON W1G 9QR, UK
immediately.
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

analyzers.
manual)
Version 2.0 SREN

1/1
Neo-4DS-Lyser 23
PRODUCT NAME Do not use reagent wich was on temperature lower

Neo-4DS Lyser than 5º C ( or reagent wich was frozen).
Cat.No. / REF N16260 42 ml bottle EXPECTED RESULTS

INTENDENT USE specification.
For In Vitro Diagnostic Use Only.
Neo-4DS-Lyser is a lysing solution for the stain LIMITATIONS
leukocytes on SYSMEX automated hematology Reagent has to be used within the ambient
analyzers. temperature range of 15C-30C.
NeoMedica reagents. If you use reagent Neo-4DS
PRINCIPLE Lyser with reagents other manufacturers you can
Neo-4DS-Lyserused in combination with Neo-4DN expect wrong results.
Lyser. Blood specimens for hematological analysis may be
Consult your specific instrument Operator's manual for stored for up to 8 hours at 15C-30C or up to 24
additional information. hours after collection when refrigerated 2C-8C.
After taking samples from the fridge, they must be
ACTIVE INGRIDIENTS brought to room temperature with constant stirring
Ethylen glycol  97 %
Methanol  2.9% MATERIALS REQUIRED BUT NOT PROVIDED
Dye  0.1 % Hematology analyzers SYSMEX XS-800i, XS-1000i,
XT-1800i, XT-2000i, XT-2100i.
PRECAUTIONS
 Only for professional use.  Neo-Diluent-ST
instrument carefully.  Neo-FB-Lyser
 Don't freeze.
 Do not use reagents beyond the expiration date  Neo-SLS-Lyser
 Before use, check the package for signs of damage.  Neo-4DN-Lyser
MANUFACTURER
immediately. NeoMedica d.o.o.
Bul Sv Cara Konstantina 82-86, 18000 Niš, Srbija
tel:+381 18 573822 fax:+381 18 573616
reagents.
PERSONAL PROTECTION Wellkang Ltd t/a Wellkang Tech Consulting

recommended.
INSTRUCTION FOR USE

analyzers.
manual)
STORAGE & STABILITY

days.
Version 1.0 SRP

2/2
Neo-FD-I Lyser 24
PRODUCT NAME
Neo-FD-I Lyser STORAGE & STABILITY
Cat.No. / REF N16273 5 L- cubitainer date of manufacture when stored at 5°C-30°C. See
Neo-FD-I Lyser is a lysing solution for the staining and Do not use reagent wich was on temperature lower
differential counting of white blood cells on SYSMEX than 5º C ( or reagent wich was frozen).
automated hematology analyzers.
It is designed for SYSMEX SF-3000 hematology EXPECTED RESULTS
analysers. It has to be used in combination with Neo-FD- Performance should be within instrument
II Lyser. specification.
PRINCIPLE LIMITATIONS
Neo-FD-I Lyser used in combination with Neo-FD-II Reagent has to be used within the ambient
Lyser, eliminates red blood cell stroma for accurate temperature range of 15°C-30°C.
counting and sizing of the Lymphocytes, Monocytes, NeoMedica reagents can be only used with other
Eosinophils, and the group of Neutrophils and Basophils NeoMedica reagents. If you use reagent Neo-FD-I
Consult your specific instrument Operator's manual for Lyser with reagents other manufacturers you can
additional information. expect wrong results.
ACTIVE INGRIDIENTS stored for up to 8 hours at 15°C-30°C or up to 24
Org. Buffer ≤ 1.0 % hours after collection when refrigerated 2°C-8°C.
Surfactant ≤ 1.5 % After taking samples from the fridge, they must be
Dye ≤ 0.5 % brought to room temperature with constant stirring
Stabilizer ≤ 0.5 %
PRECAUTIONS Hematology analyzers SYSMEX SF-3000
• Before use, please read Operator's manual of the • Neo-Diluent-ST
instrument carefully. • Neo-SLS-Lyser
• Don't freeze. • Neo-FB- Lyser
• Do not use reagents beyond the expiration date • Neo-FD-II Lyser
• Use within 60 days after opening the reagent. MANUFACTURER
• Don't ingest. Avoid skin and eyes contact. NeoMedica d.o.o.
• In case of contact, rinse with plenty of water Bul Sv Cara Konstantina 82-86, 18000 Niš, Srbija
• Seek medical advice immediately in case of ingestion email: ivd@neomedica.rs www.neomedica.rs
reagents. Wellkang Ltd t/a Wellkang Tech Consulting
LONDON W1G 9QR, UK
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

analyzers.
manual)
Version 16 SREN
2/2
Neo-FD-II Lyser 25
PRODUCT NAME STORAGE & STABILITY

Neo-FD-II Lyser Unopened reagent has stability of 18 months from
date of manufacture when stored at 5°C-30°C. See
Cat.No. / REF N16271 0.5 L- bottle package label for expiry date.
INTENDENT USE 60 days.
For In Vitro Diagnostic Use Only. Do not use reagent wich was on temperature lower
Neo-FD-I Lyser is a lysing solution for the staining and than 5º C ( or reagent wich was frozen).
differential counting of white blood cells on SYSMEX
automated hematology analyzers. EXPECTED RESULTS
It is designed for SYSMEX SF-3000 hematology Performance should be within instrument
analysers. It has to be used in combination with Neo-FD- specification.
II Lyser.
LIMITATIONS
PRINCIPLE Reagent has to be used within the ambient
Neo-FD-II Lyser used in combination with Neo-FD-I temperature range of 15°C-30°C.
Lyser, eliminates red blood cell stroma for accurate NeoMedica reagents can be only used with other
counting and sizing of the Lymphocytes, Monocytes, NeoMedica reagents. If you use reagent Neo-FD-II
Eosinophils, and the group of Neutrophils and Basophils Lyser with reagents other manufacturers you can
Consult your specific instrument Operator's manual for expect wrong results.
ACTIVE INGRIDIENTS hours after collection when refrigerated 2°C-8°C.
Buffer ≤ 3.5 % After taking samples from the fridge, they must be
Surfactant ≤ 1.0 % brought to room temperature with constant stirring
Quaternary Ammonium salt ≤ 4.5 %
PRECAUTIONS Hematology analyzers SYSMEX SF-3000
• Before use, please read Operator's manual of the • Neo-Diluent-ST
instrument carefully. • Neo-SLS-Lyser
• Don't freeze. • Neo-FB- Lyser
• Do not use reagents beyond the expiration date • Neo-FD-II Lyser
• Use within 60 days after opening the reagent. MANUFACTURER
• Don't ingest. Avoid skin and eyes contact. NeoMedica d.o.o.
• In case of contact, rinse with plenty of water Bul Sv Cara Konstantina 82-86, 18000 Niš, Srbija
• Seek medical advice immediately in case of ingestion email: ivd@neomedica.rs www.neomedica.rs
LONDON W1G 9QR, UK
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

analyzers.
manual)
Version 16 SREN
2/2
Neo-Lyser-WH 26 Package insert
Lysing reagent for lysis of erythrocytes
Cat.No. / REF N 16201 -bottle 0.5 l STORAGE & STABILITY

PRODUCT NAME months from date of manufacture when stored at 5C-
Neo-Lyser - WH 30C. See package label for expiry date.
Neo-Lyser WH is a reagent for lysis of erythrocytes in EXPECTED RESULTS

automāted hematology analyzers (designed for the Performance should be within instrument
Sysmex KX-21,KX-21N,POCH-100i hematology specification.
analyzer) .
It is designed for use with Neo-DIiluent - ST and Neo- LIMITATIONS
CelN-Cleaner manufacturer Neomedica Reagent has to be used within the ambient
PRINCIP METODE NeoMedica reagents can be only used with other
White Blood Cell, Red Blood Cell and Platelet are NeoMedica reagents. If the reagent is mixed with third
counted and sized by the Electrical Impedance Method. party reagents, incorrect results may be obtained.
This method is based on the measurement of changes in Blood specimens for hematological analysis may be
electrical resistance produced by a particle passing stored for up to 8 hours at 15C-30C or up to 24
through an aperture. hours after collection when refrigerated 2C-8C.
Consult your specific instrument Operator's manual for By taking samples from the fridge, they must be
additional information. equal to room temperature with constant stirring
ACTIVE INGRIDIENTS MATERIALS REQUIRED BUT NOT PROVIDED

Quaternary Ammonium Salts  3.0 %  Automated Haematology Analyzer (Cell Counter).
Sysmex KX-21,KX-21N,POCH-100i.
PRECAUTIONS  Neo-Diluent –ST

 Only for professional use. Cat.No. / REF N16105 20 L- cubitainer
instrument carefully.  Neo-CelN-Clean
 Don't freeze. Cat.No. / REF N16400 50 ml -bottle
 Don't ingest. Avoid skin and eyes contact. MANUFACTURER
 In case of contact, rinse with plenty of water NeoMedica d.o.o.
immediately. Bul.Sv Cara Konstantina 82-86, 18000 Niš, Srbija
 Seek medical advice immediately in case of ingestion tel:+381 18 573822 fax:+381 18 573616
recommended.
INSTRUCTION FOR USE
laboratory professional, versed for Sysmex
Haematology Analyzer.
manual)
Version 2.0 SREN

1/1
Neo CelN-Cleaner 27 Pack. Insert
SOLUTION FOR PERIODIC CLEANING
Cat.No. / REF N 16400 Bottle 50 ml STORAGE & STABILITY

date of manufacture when stored at 5C-30C. See
PRODUCT NAME
Neo-CelN-Cleaner Once installed reagent on the instument, is stable for
60 days.
INTENDENT USE
Do not use reagent wich was on temperature lower
For In Vitro Diagnostic Use Only than 5º C ( or reagent wich was frozen).
Neo-Probe Cleaner is solution for periodic cleaning
needle and systems of automated hematology
analyzers analizatore Sysmex KX-21,KX-21N, POCH- EXPECTED RESULTS
100i etc. Performance should be within instrument
specification.
METHOD PRINCIP
Consult your specific instrument Operator's manual for LIMITATIONS AND SPECIAL REQUEST
additional information. Recommendation is to use solution only for
automated hematology analyzers analizatore Sysmex
ACTIVE INGREDIENTS KX-21,KX-21N, POCH-100i.
Sodium hipohlorat  10 % .
Sodium hidroksid  5%
PRECAUTIONS PROIZVOĐAČ
 Only for professional use. NeoMedica d.o.o.
 Before use, please read Operator's manual of the Bul. Sv. Cara Konstantina 82-86, 18000 Niš, Srbija
 Don't freeze. email: ivd@neomedica.rs www.neomedica.rs
 Don”t shake.
printed on the label. Wellkang Ltd t/a Wellkang Tech Consulting
 Use within 60 days after opening the reagent. LONDON W1G 9QR, UK
 Don't ingest. Avoid skin and eyes contact. In case of
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for hematology
analyzer.
 Leave the solution at room temperature (15C-30C)
 Offer solution to the needle, press taster for sampling
and wait instrument to finish cleaning (read Operator's
manual for that analyzer)
V2.0
04.2013
2/2
Neo-Diluent BC3 28 PACKAGE INSERT
Cat.No. / REF N11103 5 L-cubitainer • Leave the reagents at room temperature (15°C-
Cat.No. / REF N11105 20 L-cubitainer 30°C) for at least 24 hours.
PRODUCT NAME MATERIALS REQUIRED BUT NOT PROVIDED)
Neo-Diluent BC3 • Prime the reagents through instruments (Operator's
manual)
INTENDENT USE • When installing a new LOT of reagents recalibrate
For In Vitro Diagnostic Use Only the instrument (Operator's manual)
Neo-Diluent BC3 is Reagents for Automated
Hematology Analyzer - diluent (dilute the blood sample). STORAGE & STABILITY
It is designed for family BC3200, BC3000 BC3000+, The reagent has an unopened stability of 24
BC2800, BC2600 and BC2300 Hematology Analyzer months from date of manufacture when stored at 5°C-
Mindray. 30°C. See package label for expiry date.
Intended for use in a set NeoMedica, with Neo-Rinse & Once installed reagent on the instrument, is stable
HGB Ref and Neo-Lyse BC3.
for 60 days.
SUMMARY & PRINCIPLE
Dilutions are prepared for whole blood to disperse the
EXPECTED RESULTS
cells so that, in most cases, the cells pass through the
aperture individually. Also in this way, the conductive
specification.
environment for cell counting and sizing is available.
The diluted specimens are aspirated into the RBC and LIMITATIONS
WBC apertures under a negative pressure. Reagent has to be used within the ambient
This method is based on the measurement of changes in
electrical resistance produced by a particle passing
through an aperture.
• Automated Hematology Analyzer (Cell Counter)
Mindray BC3200, BC3000, BC3000+, BC2800,
ACTIVE INGRIDIENTS
BC2600 or BC2300.
Sodium Sulphate Anhydrous ≤ 1.0 %
• Neo-Rinse & HGB Ref
Sodium Chloride ≤ 0.55 %
Cat.No. / REF N11313 5L-cubitainer
Buffering Agents ≤ 0.3 % Cat.No. / REF N11305 20 L-cubitainer
Anti-Microbial Agents ≤ 0.25 % • Neo-Lyse BC3
Cat.No. / REF N11201 0.5 L-bottle
PRECAUTIONS
• Only for professional use. SPECIMEN REQUIREMENTS
• Before use, please read Operator's manual of the Blood specimens for hematological analysis may be
instrument carefully. stored for up to 8 hours at 15°C-30°C or up to 24
• Don't freeze. hours after collection when refrigerated 2°C-8°C.
• Do not use reagents beyond the expiration date By taking samples from the fridge, they must be
printed on the label. equal to room temperature with constant stirring
• Use within 60 days after opening the reagent. METHOD FOR CLEANING UP
• Don't ingest. Avoid skin and eyes contact. If any absorbent material are used.. Clean with plenty
• In case of contact, rinse with plenty of water water.
immediately.
and / or eyes contact. MANUFACTURER
• Use Good Laboratory Practices when handling these NeoMedica d.o.o.
reagents. Bul.Sv Cara Konstantina 82-86, 18000 Niš, Srbija
tel:+381 18 573822 fax:+381 18 573616
PERSONAL PROTECTION email: ivd@neomedica.rs www.neomedica.rs
recommended. Wellkang Ltd t/a Wellkang Tech Consulting
LONDON W1G 9QR, UK
INSTRUCTION FOR USE
laboratory professional, versed for Mindray
Hematology Analyzer.
Version 16
Neo-Lyse BC3 29
Lysing reagent for lysis of erythrocytes PACKAGE INSERT
Cat.No. / REF N 11201 -bottle 0.5 l STORAGE & STABILITY

PRODUCT NAME months from date of manufacture when stored at 5°C-
Neo-Lyse BC3 30°C. See package label for expiry date.
Neo-Lyse BC3 is a reagent for lysis of erythrocytes in EXPECTED RESULTS

automated hematology analyzers. Designed for the Performance should be within instrument
range of BC3200, BC3000, BC3000 + BC2800, BC2600 specification.
and BC2300 hematology analyzer Mindray.
It is designed for use in the kit Neomedica, with Neo- LIMITATIONS
Rinse & HGB Ref and Neo-Diluent BC3. Reagent has to be used within the ambient
PRINCIP METODE NeoMedica reagents can be only used with other
White Blood Cell, Red Blood Cell and Platelet are NeoMedica reagents. If the reagent is mixed with third
counted and sized by the Electrical Impedance Method. party reagents, incorrect results may be obtained.
This method is based on the measurement of changes in Blood specimens for hematological analysis may be
electrical resistance produced by a particle passing stored for up to 8 hours at 15°C-30°C or up to 24
through an aperture. hours after collection when refrigerated 2°C-8°C.
Consult your specific instrument Operator's manual for By taking samples from the fridge, they must be
additional information. equal to room temperature with constant stirring
ACTIVE INGRIDIENTS MATERIALS REQUIRED BUT NOT PROVIDED

Quaternary Ammonium Salts ≤ 5.0 % • Automated Hematology Analyzer (Cell Counter)
Nonion surfactant ≤ 1.0 % Mindray BC3200, BC3000, BC3000+, BC2800,
BC2600 or BC2300.
PRECAUTIONS
• Only for professional use. • CAP component for Lyse - Mindray.
• Before use, please read Operator's manual of the Mindray REF: 3001-30-06924 or
instrument carefully. 2800-30-28818
• Don't freeze.
• Do not use reagents beyond the expiration date • Neo-Rinse & HGB Ref
printed on the label Cat.No. / REF N11313 5 L- cubitainer
• Use within 60 days after opening the reagent. Cat.No. / REF N11305 20 L- cubitainer
• In case of contact, rinse with plenty of water • Neo-Diluent BC3
immediately. Cat.No. / REF N11103 5 L- cubitainer
• Seek medical advice immediately in case of ingestion Cat.No. / REF N11105 20 L- cubitainer
reagents.
MANUFACTURER
PERSONAL PROTECTION
NeoMedica d.o.o.
Safety glasses and laboratory gloves are Bul. Svetog Cara Konstantina 82-86, 18000 Nis,
recommended. Serbia
INSTRUCTION FOR USE tel:+381 18 573822 fax:+381 18 573616
• Person installing the reagents must be a trained email: ivd@neomedica.rs www.neomedica.rs
laboratory professional, versed for Mindray
• Leave the reagents at room temperature (15°C-30°C) Wellkang Ltd t/a Wellkang Tech Consulting
for at least 24 hours. LONDON W1G 9QR, UK
manual)
Version 16
Neo-CE-Clean 30

Cat.No. / REF N 11400 Bottle 100 ml Unopened reagent has stability of 12 months from
date of manufacture when stored at 5°C- 30°C. See
PRODUCT NAME 60 days.
Neo-CE-Clean Do not use reagent wich was on temperature lower
INTENDENT USE
For In Vitro Diagnostic Use Only. EXPECTED RESULTS
Neo-CE-Clean is solution for periodic - daily cleaning Performance should be within instrument
automated hematology analyzers BC3200, BC3000, specification.
BC3000+, BC2800, BC2600 and BC2300 Mindray.
LIMITATIONS AND SPECIAL REQUEST
SUMMARY & PRINCIPLE Recommendation is to use solution only for
See instruction for your specific analyzer if you want automated hematology analyzers BC3200, BC3000,
more informations. BC3000+, BC2800, BC2600 and BC2300 Mindray.
ACTIVE INGRIDIENTS
Proteolitic enzym ≤ 0.8 % PROIZVOĐAČ
Sodium hlorid ≤ 0.5 % NeoMedica d.o.o.
Nonionic surfactants ≤ 0.15 % Bul. Sv. Cara Konstantina 82-86, 18000 Niš, Srbija
Buffering Agents ≤ 0.4 % tel:+381 18 573822 fax:+381 18 573616
Antifung. & Antibact. agents ≤ 0.25% email: ivd@neomedica.rs www.neomedica.rs
PRECAUTIONS Wellkang Ltd t/a Wellkang Tech Consulting

• Only for professional use. Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
• Don't freeze.
• Don”t shake.
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional hematology analyzer Mindray.
manual)
V16
2/2
Neo-Probe Cleaner 31 PRATEĆI LIST

Neo-Probe Cleaner Do not use reagent wich was on temperature lower
INTENDENT USE
Neo-Probe Cleaner is solution for periodic cleaning EXPECTED RESULTS
needle and systems of automated hematology Performance should be within instrument
analyzers Mindray BC3200, BC3000, BC3000+, specification.
BC2800, BC2600 and BC2300 , and other automated
hematology analyzers ( for example Phoenix NCC-2310 LIMITATIONS AND SPECIAL REQUEST
and NCC-1211 and etc.) Recommendation is to use solution only for
automated hematology analyzers Mindray BC3200,
BC3000, BC3000+, BC2800, BC2600 and BC2300;
METHOD PRINCIP Phoenix NCC-2310 and NCC-1211.
ACTIVE INGREDIENTS
Sodium hipohlorat ≤ 10 % PROIZVOĐAČ
Sodium hidroksid ≤ 5% NeoMedica d.o.o.
• Only for professional use. email: ivd@neomedica.rs www.neomedica.rs
• Don't freeze. Suite B, 29 Harley Street,
• Don’t shake. LONDON W1G 9QR, UK
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for hematology
analyzer.
• Leave the solution at room temperature (15°C-30°C)
• Offer solution to the needle, press taster for sampling
V16
2/2
Neo-Diluent NK 32 PACKAGE INSERT
TF3.06 074.005
PRODUCT NAME
Neo-Diluent NK EXPECTED RESULTS
Cat.No. / REF N110104 10 L- cubitainer Performance should be within instrument
Cat.No. / REF N110114 10 L- canister specification.
LIMITATIONS
INTENDENT USE Reagent has to be used within the ambient
For In Vitro Diagnostic Use Only. temperature range of 15C-30C.
Neo-Diluent NK is sample blood diluting reagent for NeoMedica reagent can only be used with other
NIHON KOHDEN Automated Hematology Analyzers. NeoMedica reagents. If you use reagent Neo-
Diluent
INSTRUMENTS NK with reagents other manufacturers you can
It is designed for Nihon Kohden MEK-8222, 8118, 7222, expect wrong results.
6318, 6410, 6400 hematology analysers. Blood specimens for hematological analysis may be
AKTIVE INGREDIENTS hours after collection when refrigerated 2C-8C.
Sodium sulphate anhydrous  1.1 % By taking samples from the fridge, they must be equal
Sodium hlorid  0.5 % to room temperature with constant stirring
Buffering agents  0.5 %
Anti-Mikrobial agents  0.3 %
MANUFACTURER
PRECAUTIONS NeoMedica d.o.o.
 Only for professional use. Bul.Sv Cara Konstantina 82-86, 18000 Niš, Srbija
 Before use, please read Operator's manual of the tel:+381 18 573822 fax:+381 18 573616
instrument carefully. email: ivd@neomedica.rs www.neomedica.rs
 Don't freeze.
 Do not use reagents beyond the expiration date Wellkang Ltd t/a Wellkang Tech Consulting
printed on the label. Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
immediately.
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

manual)
STORAGE & STABILITY

days.
Version 2.0 SREN

Neo-Cleanac NK 33 Package insert
STORAGE & STABILITY

Reagent for washing The reagent has an unopened stability of 12
Neo-Cleanac NK 30C in a dark place. See package label for expiry
Cat.No. / REF N110403 5 L- cubitainer date.
PRODUCT NAME for 60 days.
Neo-Cleanac NK DO NOT use reagent once frozen.
INTENDENT USE EXPECTED RESULTS

For In Vitro Diagnostic Use Only Performance should be within instrument
Enzymatic detergent for cleaning hematology analyzer specification.
Nihon Kohden MEK 8222, 7222, 6318, 6400..).
It is designed for use with Neo-DIiluent NK, Neo-Lyse LIMITATIONS
NK and Neo-Lysis NK manufacturer Neomedica. Reagent has to be used within the ambient
Neo-Cleaner NK is a cleaning reagent that effectively NeoMedica reagents. If the reagent is mixed with third
cleans out cell debris, proteins and triglycerides by party reagents, incorrect results may be obtained.
detergent solubilization. Blood specimens for hematological analysis may be
ACTIVE INGRIDIENTS hours after collection when refrigerated 2C-8C.
Protealztic enzyme ≤ 0.5 % By taking samples from the fridge, they must be
Buffer ≤ 0.1 % equal to room temperature with constant stirring
Detergents  1.0 %
PRECAUTIONS
Only for professional use. N110105 Neo-Diluent NK
Before use, please read Operator's manual of the N110303 Neo-Rinse NK
instrument carefully. N110211 Neo-Lysis NK
Don't freeze. N110201 Neo-Lyse NK
on the label
Don't ingest. Avoid skin and eyes contact. MANUFACTURER
In case of contact, rinse with plenty of water immediately. NeoMedica d.o.o.
Seek medical advice immediately in case of ingestion Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
Use Good Laboratory Practices when handling these email: ivd@neomedica.rs www.neomedica.rs
reagents.
PERSONAL PROTECTION Wellkang Ltd t/a Wellkang Tech Consulting
recommended.
INSTRUCTION FOR USE
laboratory professional, versed for Nihon Kohden
30C) for at least 24 hours.
 Prime the reagents through instruments
(Operator's manual)
 When installing a new LOT of reagents recalibrate
Version 2.0
1/1
Neo-Diluent AC 34
Cat.No. / REF N 117105 20 L-cubitainer

STORAGE & STABILITY
Neo-Diluent AC date of manufacture when stored at 5°C-30°C. See
For In Vitro Diagnostic Use Only Once installed reagent on the instument, is stable for
Neo-Diluent AC is sample blood diluting reagent for 60 days.
Automated Hematology Analyzer Phoenix NCC- 2310 Do not use reagent wich was on temperature lower
and NCC-1211. than 5º C ( or reagent wich was frozen).
Intended for use in a set NeoMedica, with Neo-R –
Cleaner and Neo-Lyser AC. EXPECTED RESULTS
METHOD PRINCIP specification.
counted and sized by the Electrical Impedance Method. LIMITATIONS
This method is based on the measurement of changes in Reagent has to be used within the ambient
electrical resistance produced by a particle passing temperature range of 15°C-30°C.
through an aperture. NeoMedica reagents can be only used with other
Consult your specific instrument Operator's manual for NeoMedica reagents. If you use reagent Neo-Diluent
additional information. AC with reagents other manufacturers you can
ACTIVE INGREDIENTS Blood specimens for hematological analysis may be
Sodium sulfat anh. ≤ 0.9 % stored for up to 8 hours at 15°C-30°C or up to 24
Sodium hlorid ≤ 0.3% hours after collection when refrigerated 2°C-8°C.
Stabilizing agents ≤ 0.2% By taking samples from the fridge, they must be equal
Anti-microbal agents ≤ 0.25 % to room temperature with constant stirring
PRECAUTIONS
• Only for professional use. REQURED REAGENTS WITH WICH IT IS USED
• Before use, please read Operator's manual of the Automated hematology analyzers, Phoenix NCC-
instrument carefully. 2310 and NCC-1211.
• Don't freeze.
• Do not use reagents beyond the expiration date • Neo-R-Cleaner
printed on the label. Cat.No. / REF N 117313 5L
• Use within 60 days after opening the reagent. • Neo-Lyser AC
• Don't ingest. Avoid skin and eyes contact. Cat.No. / REF N117201 0.5 L
immediately.
• Seek medical advice immediately in case of ingestion MANUFACTURER
and / or eyes contact. NeoMedica d.o.o.
• Use Good Laboratory Practices when handling these Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
reagents. tel:+381 18 573822 fax:+381 18 573616
PERSONAL PROTECTION
recommended. Wellkang Ltd t/a Wellkang Tech Consulting
LONDON W1G 9QR, UK
INSTRUCTION FOR USE
laboratory professional, versed for Phoenix NCC- 2310
and NCC-1211 hematology analyzers.
manual)
PL089
V16
Neo-Lyser AC 35 PRATEĆI LIST
REAGENT FOR LYZES OF ERYTHROCYTES
Cat.No. / REF N 117201 …..0.5 l

STORAGE & STABILITY
Neo-Lyser AC date of manufacture when stored at 5°C-30°C. See
INTENDENT USE Once installed reagent on the instument, is stable for
For In Vitro Diagnostic Use Only 60 days.
Neo-Lyse AC is a reagent for lysis of erythrocytes in
automated hematology analyzers Phoenix NCC-2310 EXPECTED RESULTS
and NCC-1211. Performance should be within instrument
It is designed for use in the kit Neomedica, with Neo- specification.
Diluent AC and Neo-R-Cleaner
LIMITATIONS
METHOD PRINCIP Reagent has to be used within the ambient
White Blood Cell, Red Blood Cell and Platelet are temperature range of 15°C-30°C.
counted and sized by the Electrical Impedance Method. NeoMedica reagents can be only used with other
This method is based on the measurement of changes in NeoMedica reagents. If the reagent is mixed with third
electrical resistance produced by a particle passing party reagents, incorrect results may be obtained.
through an aperture. Blood specimens for hematological analysis may be
Consult your specific instrument Operator's manual for stored for up to 8 hours at 15°C-30°C or up to 24
additional information. hours after collection when refrigerated 2°C-8°C.
ACTIVE INGREDIENTS to room temperature with constant stirring
Quaternary ammonium salt ≤ 5.0%
Buffer ≤ 1.0%
Stabilizer agents ≤ 0.2% REQUIRED REAGENT WITH WICH IT IS USED
Automated hematology analyzers, Phoenix NCC-
PRECAUTIONS 2310 and NCC-1211.
• Before use, please read Operator's manual of the • Neo-R-Cleaner
instrument carefully. Cat.No. / REF N117313 5 L- cubitainer
• Don't freeze.
• Don't shake. • Neo-Diluent AC
• Do not use reagents beyond the expiration date Cat.No. / REF N117105 20 L- cubitainer
• In case of contact, rinse with plenty of water MANUFACTURER
immediately. NeoMedica d.o.o.
• Seek medical advice immediately in case of ingestion Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
reagents.
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for Mindray Hematology
Analyzer.
manual)
PL 090
V16 SREN
Neo-R-Cleaner 36
Reagent for washing
Cat.No. / REF N117313 5 L-cubitainer • When installing a new LOT of reagents recalibrate
Cat.No. / REF N117311 0.5 L-bottle the instrument (Operator's manual)
STORAGE & STABILITY

Neo-R-Cleaner date of manufacture when stored at 5°C-30°C. See
INTENDENT USE Once installed reagent on the instument, is stable for
Neo-R Cleaner is reagent for washing tubing system of Do not use reagent wich was on temperature lower
automated hematology analyzers, Phoenix NCC- than 5º C ( or reagent wich was frozen).
2310 and NCC-1211.
It is designed for use in the kit Neomedica, with Neo- EXPECTED RESULTS
Lyser AC and Neo-Diluent AC. Performance should be within instrument
specification.
METHOD PRINCIP
White Blood Cell, Red Blood Cell and Platelet are LIMITATIONS
counted and sized by the Electrical Impedance Method. Reagent has to be used within the ambient
This method is based on the measurement of changes in temperature range of 15°C-30°C.
electrical resistance produced by a particle passing NeoMedica reagents can be only used with other
through an aperture. NeoMedica reagents. If you use reagent Neo-R-
Consult your specific instrument Operator's manual for Cleaner with reagents other manufacturers you
additional information. can expect wrong results.
ACTIVE INGREDIENTS
Proteolytic enzyme ≤ 0.5 %
Sodium hlorid ≤ 1.0 %
Detergents ≤ 1.0 % to room temperature with constant stirring.
PRECAUTIONS
• Only for professional use. REQUIRED REAGENTS WITH WICH IT IS USED
• Before use, please read Operator's manual of the Automated hematology analyzers, Phoenix NCC-
instrument carefully. 2310 and NCC-1211.
• Don't freeze.
• Don”t shake. • Neo-Lyser AC
• Do not use reagents beyond the expiration date Cat.No. / REF N117201-0.5L
• Use within 60 days after opening the reagent. • Neo-Diluent AC
• Don't ingest. Avoid skin and eyes contact. In case of Cat.No. / REF N 117103 5 L- cubitainer
contact, rinse with plenty of water immediately. Cat.No. / REF N 117105 20 L- cubitainer
• Use Good Laboratory Practices when handling these MANUFACTURER
reagents. NeoMedica d.o.o.
Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
PERSONAL PROTECTION tel:+381 18 573822 fax:+381 18 573616
Safety glasses and laboratory gloves are email: ivd@neomedica.rs www.neomedica.rs
recommended.
INSTRUCTION FOR USE Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
laboratory professional, versed for Phoenix NCC-
2310 and NCC-1211 hematology analyzers.
manual)
PL091
Version V16 SREN
1/1
Neo-EA-Cleaner 37

date of manufacture when stored at 5°C- 30°C. See
PRODUCT NAME Once installed reagent on the instrument, is stable for
Neo-EA-Cleaner 60 days.
INTENDENT USE than 2º C ( or reagent wich was frozen).
For In Vitro Diagnostic Use Only.
Neo-EA-Cleaner is solution for periodic - daily cleaning EXPECTED RESULTS
automated hematology analyzers Phoenix NCC-2310 Performance should be within instrument
and NCC-1211. specification.
SUMMARY & PRINCIPLE LIMITATIONS AND SPECIAL REQUEST

See instruction for your specific analyzer if you want Recommendation is to use solution only for
more informations. automated hematology analyzers Phoenix NCC-2310
and NCC-1211.
ACTIVE INGRIDIENTS
Proteolitic enzym ≤ 0.8 %
Sodium hlorid ≤ 0.5 % PROIZVOĐAČ
Nonionic surfactants ≤ 0.15 % NeoMedica d.o.o.
Buffering Agents ≤ 0.4 % Bul. Sv. Cara Konstantina 82-86, 18000 Niš, Srbija
Antifung. & Antibact. agents ≤ 0.25% tel:+381 18 573822 fax:+381 18 573616
PRECAUTIONS
• Only for professional use. Wellkang Ltd t/a Wellkang Tech Consulting
• Before use, please read Operator's manual of the LONDON W1G 9QR, UK
• Don't freeze.
• Don’t shake.
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional hematology analyzer Phoenix.
manual)
V16
2/2
38
Neo-U-Sheath
WHOLE BLOOD SHEATH REAGENT

EXPECTED RESULTS
Neo-U-Sheath specification.
Cat.No. / REF N117123 5 L- cubitainer LIMITATIONS
Neo-U-Sheath is sample blood diluting reagent, used for party reagents, incorrect results may be obtained.
WBC counting and differentiation in WOC channel of
Phoenix NCC-5500, NCC-51 automated hematology MATERIALS REQUIRED BUT NOT PROVIDED
analyzers. Automated Hematology Analyzer (Cell Counter)
Intended for use with NeoMedica reagents. Phoenix NCC-5500, NCC-51.
NeoMedica set reagents.
ACTIVE INGRIDIENTS SPECIMEN REQUIREMENTS

Buffering Agents ≤ 0.1 % Blood specimens for hematological analysis may be
Nonion surfactant ≤ 0.1 % stored for up to 8 hours at 15°C-30°C or up to 24
Stabilization Agents ≤ 0.2% hours after collection when refrigerated 2°C-8°C.
• Baefore use, check the package for signs of damage.
• Use within 60 days after opening the reagent. Suite B, 29 Harley Street,
immediately.
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for Phoenix NCC
manual)
STORAGE & STABILITY

package label for expiry date. Package insert
for 60 days.
V 16 SREN
1/1
Neo-U-Diluent 39
STORAGE & STABILITY

Cat.No. / REF N 117145 20 L-cubitainer Unopened reagent has stability of 24 months from
PRODUCT NAME
60 days.
Neo- U-Diluent Do not use reagent wich was on temperature lower
Neo-U-Diluent is sample blood diluting reagent for EXPECTED RESULTS
Automated Hematology Analyzer Phoenix NCC-5500, Performance should be within instrument
NCC-51. specification.
Intended for use in a set NeoMedica, with Neo-U-
Sheath, Neo-Cleanser and Neo-Lyser-WHP LIMITATIONS
METHOD PRINCIP temperature range of 15°C-30°C.
Consult your specific instrument Operator's manual for NeoMedica reagents can be only used with other
additional information. NeoMedica reagents. If you use reagent Neo-U-
Diluent with reagents other manufacturers you
ACTIVE INGREDIENTS
can expect wrong results.
Sodium sulfat anh. ≤ 1.5 %
Sodium hlorid ≤ 0.6%
Buffering agents ≤ 0.2%
Anti-microbal agents ≤ 0.2% By taking samples from the fridge, they must be
PRECAUTIONS
• Before use, please read Operator's manual of the REQURED REAGENTS WITH WICH IT IS USED
instrument carefully. Automated hematology analyzers, Phoenix NCC-
• Don't freeze. 5500, NCC-51.
• Do not use reagents beyond the expiration date • Neo-Cleanser
printed on the label. Cat.No. / REF N 117325 20 L
• Use within 60 days after opening the reagent. • Neo-Lyser -WHP
• Don't ingest. Avoid skin and eyes contact. Cat.No. / REF N117212 1L
immediately. • Neo-U-Sheath
• Seek medical advice immediately in case of ingestion Cat.No. / REF N117125 20 L
reagents. MANUFACTURER
NeoMedica d.o.o.
PERSONAL PROTECTION Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
Safety glasses and laboratory gloves are tel:+381 18 573822 fax:+381 18 573616
recommended. email: ivd@neomedica.rs www.neomedica.rs
INSTRUCTION FOR USE

Person installing the reagents must be a trained Wellkang Ltd t/a Wellkang Tech Consulting
laboratory professional, versed for Phoenix NCC-5500, Suite B, 29 Harley Street,
NCC-51 hematology analyzers. LONDON W1G 9QR, UK
manual)
V16 SREN
Package insert
Neo-U-Stain 40
Reticulocyte Stain for Hematology Analyzer Once installed reagent on the instrument, is stable
for 60 days.
PRODUCT NAME DO NOT use reagent once frozen.
Neo-U-Stain
Cat.No. / REF N117222 4mL EXPECTED RESULTS
specification.
INTENDENT USE
For In Vitro Diagnostic Use Only LIMITATIONS
1. Add 20uL blood samples to be tested to reticulocyte temperature range of 15°C-30°C.
dye test tube, and place it at about 30 ° C ~ 35 ° C for NeoMedica reagents can be only used with other
15 to 30 minutes after mixing. NeoMedica reagents. If the reagent is mixed with third
2. The accuracy of the results will be affected more than party reagents, incorrect results may be obtained.
2 hours.
NOTE MATERIALS REQUIRED BUT NOT PROVIDED
Avoid contacting with skin and clothing when using the Automated Hematology Analyzer (Cell Counter)
reticulocyte reagent, since it contains new methylene Phoenix NCC-5500, NCC-51.
blue which will contaminate skin, clothing and many Neomedica set reagents.
other surfaces.
SPECIMEN REQUIREMENTS
ACTIVE INGRIDIENTS stored for up to 8 hours at 15°C-30°C or up to 24
New Methylene Blue ≤ 0.3 % hours after collection when refrigerated 2°C-8°C.
• Use within 60 days after opening the reagent. Wellkang Ltd t/a Wellkang Tech Consulting
immediately.
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for Phoenix NCC
manual)
STORAGE & STABILITY

V 16 SREN
1/1
Neo-Lyser-WHP 41
REAGENT FOR LYZES OF ERYTHROCYTES
Cat.No. / REF N 117212 …1 l EXPECTED RESULTS
Cat.No. / REF N 117211 …0.5l Performance should be within instrument
specification.
PRODUCT NAME
Neo-Lyser-WHP LIMITATIONS
Neo-Lyser-WHP is a reagent for lysis of erythrocytes in party reagents, incorrect results may be obtained.
automated hematology analyzers Phoenix NCC-5500, Blood specimens for hematological analysis may be
NCC-51. stored for up to 8 hours at 15°C-30°C or up to 24
It is designed for use with Neo-U-Diluent, Neo-U-sheath hours after collection when refrigerated 2°C-8°C.
and Neo-Cleanser By taking samples from the fridge, they must be equal
to room temperature with constant stirring
METHOD PRINCIP
additional information. REQUIRED REAGENT WITH WICH IT IS USED
Automated hematology analyzers, Phoenix NCC-
ACTIVE INGREDIENTS 5500, NCC-51.
Quaternary ammonium salt ≤ 5.0%
• Neo-Cleanser
PRECAUTIONS Cat.No. / REF N 117325 20 L
• Only for professional use. Cat.No. / REF N 117324 10 L
instrument carefully. • Neo-U-Diluent
• Don't freeze. Cat.No. / REF N117145 20 L
• Don't shake.
• Do not use reagents beyond the expiration date • Neo-U-Sheath
printed on the label. Cat.No. / REF N117125 20 L
immediately.
• Use Good Laboratory Practices when handling these Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
reagents. tel:+381 18 573822 fax:+381 18 573616
PERSONAL PROTECTION
Safety glasses and laboratory gloves are Suite B, 29 Harley Street,
recommended. LONDON W1G 9QR, UK
INSTRUCTION FOR USE

laboratory professional, versed for Phoenix Hematology
Analyzer.
manual)
STORAGE & STABILITY

of manufacture when stored at 5°C-30°C. See package
days.
V16 SREN
Neo-Rinse&HGB Ref 42 PACKAGE INSERT
Reagent for washing
Cat.No. / REF N 11313 5 L- cubitainer • When installing a new LOT of reagents recalibrate
Cat.No. / REF N 11305 20 L- cubitainer the instrument (Operator's manual)
STORAGE & STABILITY

Neo-Rinse&HGB Ref date of manufacture when stored at 5°C-30°C. See
Neo-Rinse&HGB Ref is reagents for washing tubing Do not use reagent wich was on temperature lower
system of automated hematology analyzers, BC3200, than 5º C ( or reagent wich was frozen).
BC3000, BC3000+, BC2800, BC2600 and BC2300 -
Mindray EXPECTED RESULTS
It is designed for use in the kit Neomedica, with Neo- Performance should be within instrument
Lyse BC3 and Neo-Diluent BC3. specification.
METHOD PRINCIP LIMITATIONS

White Blood Cell, Red Blood Cell and Platelet are Reagent has to be used within the ambient
counted and sized by the Electrical Impedance Method. temperature range of 15°C-30°C.
This method is based on the measurement of changes in NeoMedica reagents can be only used with other
electrical resistance produced by a particle passing NeoMedica reagents. If you use reagent Neo-
through an aperture. Rinse&HGB with reagents other manufacturers
Consult your specific instrument Operator's manual for you can expect wrong results.
ACTIVE INGREDIENTS hours after collection when refrigerated 2°C-8°C.
Sodium sulfat anh. ≤ 1.0 % By taking samples from the fridge, they must be equal
Sodium hlorid ≤ 0.55 % to room temperature with constant stirring.
Emulsion agents ≤ 0.05 %
Anti microbal agents ≤ 0.05% REQUIRED REAGENTS WITH WICH IT IS USED
Automated hematology analyzers, Mindray BC3200,
PRECAUTIONS BC3000, BC3000+, BC2800, BC2600 and BC2300
• Before use, please read Operator's manual of the • Neo-Lyse BC3
instrument carefully. Cat.No. / REF N11201
• Don't freeze.
• Don’t shake. • Neo-Diluent BC3
Cat.No. / REF N 11103 5 L- cubitainer
Cat.No. / REF N 11105 20 L- cubitainer
• Use Good Laboratory Practices when handling these Bul.Sv Cara Konstantina 82-86, 18000 Niš, Srbija
reagents. tel:+381 18 573822 fax:+381 18 573616
PERSONAL PROTECTION
Safety glasses and laboratory gloves are Wellkang Ltd t/a Wellkang Tech Consulting
recommended. Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
INSTRUCTION FOR USE

laboratory professional, versed for Mindray hematology
analyzers.
manual)
Version 16
1/1
43
Neo Detergent C
Reagent for washing

PRODUCT NAME package label for expiry date.
Neo Detergent C Once installed reagent on the instrument, is stable for
60 days.
INTENDENT USE Do not use reagent wich was on temperature lower
For In Vitro Diagnostic Use Only. than 5º C ( or reagent wich was frozen).
Neo Detergent C is reagent for washing tubing system
of automated hematology analyzers, Phoenix NCC-3300. EXPECTED RESULTS
It is designed for use in the kit NeoMedica, with Neo Performance should be within instrument
Lyse C and Neo Diluent C. specification.
METHOD PRINCIP LIMITATIONS

White Blood Cell, Red Blood Cell and Platelet are Reagent has to be used within the ambient
counted and sized by the Electrical Impedance Method. temperature range of 15°C-30°C.
This method is based on the measurement of changes in NeoMedica reagents can be only used with other
electrical resistance produced by a particle passing NeoMedica reagents. If you use reagent Neo
through an aperture. Detergent C with reagents other manufacturers
Consult your specific instrument Operator's manual for you can expect wrong results.
ACTIVE INGREDIENTS hours after collection when refrigerated 2°C-8°C.
Proteolytic enzyme ≤ 0.3 % By taking samples from the fridge, they must be equal
Sodium hlorid ≤ 1.0 % to room temperature with constant stirring.
Detergents ≤ 1.0 %
Buffer ≤ 0.5 %
REQUIRED REAGENTS WITH WICH IT IS USED
PRECAUTIONS Automated hematology analyzers Phoenix NCC-
• Only for professional use. 3300.
instrument carefully. • Neo Lyse C
• Don't freeze.
• Don’t shake. • Neo Diluent C
• Don't ingest. Avoid skin and eyes contact. In case of MANUFACTURER
contact, rinse with plenty of water immediately. NeoMedica d.o.o.
• Seek medical advice immediately in case of ingestion Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
reagents.
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for NCC-3300
manual)
V 3.0, 2016
Neo Diluent C
Cat.No. / REF N 128105 20 L-cubitainer

Cat.No. / REF N 128103 5L-cubitainer STORAGE & STABILITY
PRODUCT NAME date of manufacture when stored at 5°C-30°C. See
Neo Diluent C package label for expiry date.
For In Vitro Diagnostic Use Only 60 days.
Neo Diluent C is sample blood diluting reagent for Do not use reagent wich was on temperature lower
Automated Hematology Analyzer Phoenix NCC-3300. than 5º C ( or reagent wich was frozen).
Intended for use in a set NeoMedica, with Neo
Detergent C and Neo Lyse C. EXPECTED RESULTS
METHOD PRINCIP specification.
counted and sized by the Electrical Impedance Method. LIMITATIONS
This method is based on the measurement of changes in Reagent has to be used within the ambient
electrical resistance produced by a particle passing temperature range of 15°C-30°C.
through an aperture. NeoMedica reagents can be only used with other
Consult your specific instrument Operator's manual for NeoMedica reagents. If you use reagent Neo Diluent
additional information. C with reagents other manufacturers you can
ACTIVE INGREDIENTS Blood specimens for hematological analysis may be
Sodium sulfat anh. ≤ 1.5 % stored for up to 8 hours at 15°C-30°C or up to 24
Sodium hlorid ≤ 1.0% hours after collection when refrigerated 2°C-8°C.
Stabilizing agents ≤ 0.3% By taking samples from the fridge, they must be equal
Anti-microbal agents ≤ 0.2 % to room temperature with constant stirring
PRECAUTIONS
• Only for professional use. REQURED REAGENTS WITH WICH IT IS USED
• Before use, please read Operator's manual of the Automated Hematology analyzer, Phoenix NCC-3300
• Don't freeze. • Neo Detergent C
printed on the label. • Neo Lyse C
immediately. Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
• Seek medical advice immediately in case of ingestion tel:+381 18 573822 fax:+381 18 573616
reagents.
PERSONAL PROTECTION Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
recommended.
INSTRUCTION FOR USE

manual)
V3.0, 2016
Neo Lyse C
REAGENT FOR LYSIS OF ERYTHROCYTES

PACKAGE INSERT
Cat.No. / REF N 128201 1 l bottle
Cat.No. / REF N 128202 0,5 l bottle STORAGE & STABILITY
PRODUCT NAME months from date of manufacture when stored at 5°C-
Neo Lyse C 30°C. See package label for expiry date.
Neo Lyse C is a reagent for lysis of erythrocytes in EXPECTED RESULTS

automated hematology analyzers. Designed for the Performance should be within instrument
Phoenix NCC-3300. specification.
It is designed for use in the kit NeoMedica, with Neo
Diluent C and Neo Detergent C. LIMITATIONS
PRINCIPLE temperature range of 15°C-30°C.
White Blood Cell, Red Blood Cell and Platelet are NeoMedica reagents can be only used with other
counted and sized by the Electrical Impedance Method. NeoMedica reagents. If the reagent is mixed with third
This method is based on the measurement of changes in party reagents, incorrect results may be obtained.
electrical resistance produced by a particle passing Blood specimens for hematological analysis may be
through an aperture. stored for up to 8 hours at 15°C-30°C or up to 24
Consult your specific instrument Operator's manual for hours after collection when refrigerated 2°C-8°C.
additional information. By taking samples from the fridge, they must be
ACTIVE INGREDIENTS
Quaternary Ammonium Salt ≤ 4.5 % MATERIALS REQUIRED BUT NOT PROVIDED
Stabilizer agents ≤ 0.2 % Hematology Analyzer (Cell Counter) NCC-3300.
Buffer ≤ 1.0 %
• Neo Detergent C
PRECAUTIONS
• Only for professional use. • Neo Diluent C
• Don't freeze.
printed on the label MANUFACTURER
• Use within 60 days after opening the reagent. NeoMedica d.o.o.
• Don't ingest. Avoid skin and eyes contact. Bul. Sv. Cara Konstantina 82-86, 18000 Nis, Serbia
• In case of contact, rinse with plenty of water tel:+381 18 573822 fax:+381 18 573616
immediately. email: ivd@neomedica.rs www.neomedica.rs
and / or eyes contact. Wellkang Ltd t/a Wellkang Tech Consulting
• Use Good Laboratory Practices when handling these Suite B, 29 Harley Street,
LONDON W1G 9QR, UK
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE
manual)
V3.0, 2016
Neo Cleaner 100
STORAGE & STABILITY

Cat.No. / REF N 239301 Bottle 100 ml Unopened reagent has stability of 12 months from
Neo Cleaner 100 Do not use reagent wich was on temperature lower
INTENDENT USE
Neo Cleaner 100 is solution for periodic cleaning EXPECTED RESULTS
needle and systems of automated hematology Phoenix Performance should be within instrument
NCC-3300. specification.
METHOD PRINCIP LIMITATIONS AND SPECIAL REQUEST

Consult your specific instrument Operator's manual for Recommendation is to use solution only for
additional information. automated hematology analyzers Phoenix NCC-3300.
ACTIVE INGREDIENTS
Sodium hipohlorat ≤ 10 %
Sodium hidroksid ≤ 5% PROIZVOĐAČ
NeoMedica d.o.o.
PRECAUTIONS Bul. Sv. Cara Konstantina 82-86, 18000 Niš, Srbija
• Only for professional use. tel:+381 18 573822 fax:+381 18 573616
• Before use, please read Operator's manual of the email: ivd@neomedica.rs www.neomedica.rs
• Don't freeze.
• Don”t shake. Wellkang Ltd t/a Wellkang Tech Consulting
• Do not use reagents beyond the expiration date LONDON W1G 9QR, UK
reagents.
PERSONAL PROTECTION
recommended.
INSTRUCTION FOR USE

laboratory professional, versed for hematology analyzer.
• Leave the solution at room temperature (15°C-30°C)
• Offer solution to the needle, press taster for sampling
V3.0, 2016

Phoenix NCC 1211

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Phoenix NCC-1211

OPERATION MANUAL ......................................................................................................... I

NEOMEDICA DOO ................................................................................................................ I

COPYRIGHT AND STATEMENT ......................................................................................... i

HOW TO USE THE MANUAL ............................................................................................... 1

SAFETY NOTICE .................................................................................................................... 3

OPERATION NOTICE ........................................................................................................... 5

CHAPTER 1 INSTRUMENT INTRODUCTION ............................................................... 6

1.1 NAME ........................................................................................................................ 6

1.2 STRUCTURE ............................................................................................................ 6

1.3 PURPOSE .................................................................................................................. 6

1.4 SPECIFICATION ..................................................................................................... 7

1.5 STRUCTURE .......................................................................................................... 11

1.6 OPERATION .......................................................................................................... 13

1.7 DETECTION PRINCIPLES ................................................................................. 19

CHAPTER 2 INSTALLATION ............................................................................................. 23

2.2 UNPACKING .......................................................................................................... 23

2.3 INSTALLATION REQUIREMENTS .................................................................. 23

2.4 REAGENT TUBING CONNECTION .................................................................. 24

2.5 RECORDER PAPER INSTALLATION .............................................................. 26

2.6 KEYBOARD AND MOUSE INSTALLATION ................................................... 26

2.7 PRINTER INSTALLATION (OPTIONAL) ........................................................ 27

2.8 POWER CABLE CONNECTION ........................................................................ 27

CHAPTER3 SAMPLE ANALYSIS ...................................................................................... 28

3.1 PREPARATION BEFORE STARTUP ................................................................ 28

3.2 STARTUP ................................................................................................................ 28

3.3 BACKGROUND TEST .......................................................................................... 29

3.4 QUALITY CONTROL ........................................................................................... 30

3.5 PREPARATION FOR SAMPLE COLLECTION .............................................. 30

3.6 SAMPLE COUNT AND ANALYSIS .................................................................... 33

3.7 ANALYTICAL RESULTS MODIFICATION .................................................... 36

CHAPTER 4 QUALITY CONTROL ................................................................................... 38

4.1 L-J QUALITY CONTROL EDIT ......................................................................... 38

4.2 L-J ANALYSIS ....................................................................................................... 40

4.3 L-J CHART VIEW ................................................................................................. 41

4.4 L-J QUALITY CONTROL LIST VIEW .............................................................. 42

CHAPTER 5 CALIBRATION .............................................................................................. 44

5.1 MANUAL CALIBRATION ................................................................................... 44

5.2 AUTO CALIBRATION ......................................................................................... 47

9.6 MAINTENANCE BEFORE TRANSPORT OR FOR THE INSTRUMENT

ANNEX 2: TOXIC MATTER OR ELEMENTS NAME AND CONTENT ........................ 97

ANNEX 3: SUPPORTED EXTERNAL PRINTER ............................................................. 98

COPYRIGHT AND STATEMENT

Copyright ©NeoMedica DOO , all rights reserved.

Manual would bring you the best experience and conveniences.

not duplicate, copy, translate, or disclose this manual in any form.

of changing the content of this manual without prior notice.

 Phoenix NCC-1211 Hematology Analyzer Operation Manual involves the agreement

and service between NeoMedica DOO and user.

malfunction or error resulting from improper operating the instrument.

 Upon request, NeoMedica DOO may provide, with compensation,

necessary circuit diagrams and other information to help qualified technician to

 Freight charges (including customs charges and insurance).

 Related losses caused by the instrument can not be used normally.

caused by direct, indirect or consequential damages and delay:

 Maintain the instrument out of accordance with maintenance regulations.

 Use the reagent or accessories not provided or authorized by NeoMedica DOO

 Replace accessories unauthorized by NeoMedica DOO or personnel

unauthorized by NeoMedica DOO repairs or modifies the instrument.

advice, please contact us.

CUSTOMER SERVICE INFORMATION:

Address: street Cara Konstantina 82-86, 18000 Niš, Serbia

Fax: +381 (18) 573-616

Phoenix NCC-1211 Hematology Analyzer Operation Manual involves the agreement

Upon request, NeoMedica DOO may provide, with compensation,

Freight charges (including customs charges and insurance).

Related losses caused by the instrument can not be used normally.

Maintain the instrument out of accordance with maintenance regulations.

Use the reagent or accessories not provided or authorized by NeoMedica DOO

Replace accessories unauthorized by NeoMedica DOO or personnel

Avoid electric shock

Defence for biohazrd and chemical hazards

Prevention of fire and explosion

Limitation of operating environment

The instrument should be installed according to the required installation environment

Maintenance and service

Standard Classification of the Instrument

Parameters of Measurement Basic Parameters: