Chapter 4 Installation

4.2 Unpacking and Inspection

Take out the analyzer and accessories from shipping carton carefully,
keep the packing material for future transport or storage.

(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.

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 50 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

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⮚ Analyzer should be used in the condition of well ground connection for

ensuring accuracy of analyzer 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 shall 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℃(Optimum temperature is 25℃)

(2) Relative humidity: 30% ~ 85%

(3) Recommend to install heating and cooling air conditioning

(4) Avoid using the analyzer 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 analyzer by
producing high frequency electric wave.

(8) Electromagnetic compatibility design for class A of group1,

electromagnetic environment assessment should be carried out before use.

WARNING

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The analyzer takes full account of the electromagnetic compatibility problems.

The electromagnetic interference generated by analyzer does not disturb itself
and devices nearby. If the test result has a large deviation, please check
whether the analyzer is placed near an electromagnetic field or a short wave
radioactive source (radar, X ray, centrifuge, scanner, cell phone etc).

4.6 Waste Requirements

For every 20L waste, it is recommended to add the following chemicals
into waste containers.

(1) 50ml of sodium hydroxide solution (200g / L) to prevent gas forming.

(2) 250ml of sodium hypochlorite solution (12% chlorine) to handle the waste
biological risk.

WARNING

⮚ To prevent environmental pollution, the waste is prohibited to pour into the

sewer directly. The waste must be processed by biological or chemical
methods before pouring into the sewer. Hospitals and laboratories have
the obligation to comply with the relevant provisions of environmental
protection department of local government.

4.7 System Installation

 
4.7.1 Tubing Installation
There are five tube-connectors on the back panel, which are DETERGENT,
DILUENT, LYSE, SHEATH and WASTE. Each of them is wrapped with a cap
to avoid contamination by the NeoMedica before delivery. Uncover and set
the caps aside carefully for further use on initial installation.

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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,

manufacturers recommend that all reagents should be placed on the
same base and lower than analyzer position.

1. LYSE Tubing Installation

Take out the lyse tube with red faucet from the accessories box, and inset
it to the LYSE connector on the back panel. Place the other end of the tube
into the lyse container and twist the cap tightly.
2. DILUENT Tubing Installation

Take out the diluent tube with blue faucet from the accessories box, and
inset it to the DILUENT connector on the back panel. Place the other end of
the tube into the diluent container and twist the cap tightly.
3. DETERGENT Tubing Installation

Take out the detergent tube with green faucet from the accessories box,
and inset it to the DETERGENT connector on the back panel. Place the other
end of the tube into the detergent container and twist the cap tightly.
4. SHEATH Tubing Installation

Take out the sheath tube with yellow faucet from the accessories box,
and inset it to the SHEATH connector on the back panel. Place the other end
of the tube into the sheath container and twist the cap tightly.
5. WASTE Tubing Installation

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 Chapter 4 Installation

  Take out the waste tube with faucet from the accessories box, and inset it
to the connector on the back panel. Inset BNC plug to the SENSOR connector
on the left panel. Tightly twist the tube’s cap clockwise onto the waste
container. Place the waster container on the level at least 50cm lower than the
analyzer.

4.7.2 Printer Installation

Please install the printer according to the following steps.

1. Place the printer in an appropriate location adjacent to the analyzer 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 analyzer 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 are as follows.

1. Select "Prepare Shipping" in "Maint" interface.

2. Follow the prompts to unplug the relevant tubing connectors.

3. Analyzer starts emptying operation.

4. Shut down the analyzer after emptying.

5. Keep well all reagents’ tubes.

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NOTE

⮚ Storage temperature: -20℃~ 55℃

⮚ Relative Humidity: ≤ 95%

⮚ Atmospheric pressure: 50kPa-106kPa

⮚ Before delivery, external disinfection is needed.

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 Chapter 5 Principles of Operation

5. Principles of Operation

5.1 Overview
NCC-61 uses electrical impedance method (also known as Coulter
principle) to detect the amount and volume distribution of RBC and PLT. The
colorimetric method is for determining the content of HGB. The Multi-angle
laser scattered method is for the five part differential of WBC. Three
separated channels are used for getting the blood cells counting results
respectively.
  (1)
WBC and five part differential data of sheath flow regulator are detected by
laser.
    
(2) HGB is detected by colorimetric assay in WBC/HGB transducer.
(3) The data of RBC and PLT is detected by electrical impedance analysis in
RBC transducer.
The analyzer aspirates, dilutes and mixes the samples and then
detects parameters in each counting process.

5.2  Sample Aspiration

NCC-61 supports two modes of blood cell counting analysis.

1. Whole blood sampling mode

2. Diluent sampling mode

The aspiration volumes:

Whole blood sampling: ≤ 20µL

Diluent sampling: ≤ 20 µL

The whole blood sample is aspirated into the analyzer by the precision

stepper motor and distributed into different measuring channels.

5.3 Sample Dilution

The sample is divided into three parts after being aspirated. These three
samples go to the WBC counting chambers, RBC counting chambers and
WOC cup respectively, and react with different reagents. Then finally getting
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the results of WBC count/HGB test, WBC/PLT count and WBC five part
differential.

5.3.1 Whole Blood Sampling & 5Diff

（1） WBC / HGB Dilution Process

（2） RBC / PLT Dilution Process

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（3） WBC Differential Dilution Process

5.3.2 Pre-diluent CBC & 5Diff

（1）WBC / HGB Dilution Process

（2）RBC / PLT Dilution Process

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（3）WBC Differential Dilution Process

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 Chapter 5 Principles of Operation

5.4 WBC Test Principle

5.4.1 Multi-Angle Laser Light Scatter Technology

Figure 5-1 Sheath Flow Regulator

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. Different
types of cells at different angles scattered light intensity is different due to the
differences of cell size, cell membrane and cell internal structure. Scattered
light signals received by photodetector at each angle are converted into
different amplitudes of the pulse signals. By analyzing the pulse signals of
different angles, we can get the scatter plot which represents the cell volume
and related information. WBC are classified by the distribution of the pulse
signals and the scatter plot.
 

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Figure 5-2 Scatter Diagram

The gray area 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.

5.4.2 WBC Classification

    
Theanalyzer divides the WBC into basophil, eosinophil, monocyte,
neutrophil and lymphocyte via Multi-Angle scatter analysis as the WBC going
through the sheath flow regulator. The default unit of cell amounts is 10^9/L.

● White Blood Cell Number

Get the value of WOC and WIC simultaneously by laser and electrical
impedance methods

● Lymphocyte Number (Lym#)

● Lymphocyte Percent
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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( Baso#)
● Basophil Percent
Baso%=Baso#/WBC

5.5 Test Principle of Hemoglobin Concentration

5.5.1 Colorimetry Principle

  Add
lyse into the diluted sample in WBC transducer, RBC dissolves and
hemoglobin is released. The hemoglobin combines with lyse to form
  hemoglobin mixture which is illuminated by the LED light-emitting diode with a

540nm-wavelength monochromatic light at one end of the WBC transducer.

Using the optical tube to receive the transmitted light at the other end,
amplifying the light intensity signal and convert it to the voltage signal.
Compare it with the voltage generated by the transmission light intensity
before adding the sample into the colorimetry chamber (only with diluent), the
  hemoglobin concentration is achieved. Hemoglobin concentration is

proportional to the sample absorbance in 540nm wavelength. The process of

measurement and calculation is done automatically by the analyzer, relevant
results is displayed in the analysis results area.

5.5.2 HGB Parameter

Hemoglobin (HGB) concentration is calculated by the following formula.

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5.6 RBC /PLT Test Principle

5.6.1    Electrical Impedance Principle

The analyzer uses the traditional electrical impedance for the blood cells
testing and counting. As shown in Figure 5-4, conductive liquid (mainly
diluent) provides constant current source for electrode to help the circuit form
a stable impedance loop. When cells pass through the pores, the conductive
liquid is substituted by cells, and the resistance of loop changes to produce
electrical pulses. As different volumes of cells passing through the pore,
different electrical pulses amplitude is generated. The number and size of
cells are determined according to the number and amplitude of electrical
pulses.

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 RBC, WBC, PLT and other groups
in accordance with pre-set volume classification procedure.

Figure 5-3 Electrical Impedance

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5.6.2 Volumetric Metering

 
Figure 5-4 Volumetric Metering

The volumetric metering unit controls the sample size passing through
the pore during counting to obtain the exact counting results in quantitative
  samples. The volumetric metering unit includes metering tube and two

photoelectric sensors.
As shown in Figure 5-5, empty the metering tube before testing. The
liquid level of metering tube declines slowly as the sample passing through
the pore. When the liquid level passes through the start detector, one
electrical signal generates, and the analyzer starts counting. When the liquid
level reaches the stop detector, it also generates an electrical signal, then the
counting finishes. If there were bubbles or other abnormal stream in the flow
system, "bubble" or "clog" alarm pops up. Please refer to Chapter 11
Troubleshooting.

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5.6.3 RBC Parameters

● RBC Number

The analyzer gets the number of red blood cell (RBC) by measuring the
corresponding electrical pulse numbers of RBC directly. The unit is 10^12/L.

RBC = n ×10^12 / L
● 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 pg. 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.

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● 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.

●   RBC Distribution Width

  The
RBC Distribution Width (RDW) which is gotten from the RBC
histogram is the geometric standard deviation of RBC volume distribution (10
GSD).

5.6.4 PLT Parameters

● PLT Number
 The analyzer gets the number of platelet (PLT) by measuring the
 corresponding electrical pulses of RBC directly. The unit is 10^9/L.

PLT = n ×10^9/ 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).
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● PCT

The PLT is calculated as follows. The unit of PLT is 10^9/L. The unit of
MPV is fL

5.7 Principles of Reticulocyte Analysis

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. The RNA can be considered as a kind of
in vitro cationic dyes which simultaneously stain and precipitate the polyanion
to form a net or reticulum.

5.7.1 RBC Development Process

The development process of RBC system in skeleton is : multipotential
stem cells→monopotential stem cells→prorubricyte→polychromatic
erythroblast→metarubricyte→reticulocyte→mature erythrocyte. So
reticulocyte is a immature red blood cell which has taken off cell nucleus, and
it’s a phase of RBC development process.

5.7.2 Characteristics of Reticulocyte

1、It contains ribosome（RNA）-- a kind of alkaline matter containing
dotted or net structure.

2、After reticulocyte is vital stained by brilliant crystal blue, the dotted or

net structure will be stained blue.

3、The reticulocyte in blood circulation takes about 24-48 hours to

mature.
Figure 5-5 Dyed Reticulocytes

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5.7.3 Testing Principle of Reticulocyte

Reticulocytes contain alkaline matter RNA which have dotted or net
structures, but mature RBC hasn’t. For this reason, we can distinguish mature
RBC and reticulocyte, as Figure 5-6.

Stain samples firstly:

Figure 5-6 Staining

Illuminated with polarized light, the stained dotted or net substances will
strengthen scatted light on wide-angle direction:

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Figure 5-1 Cells scatting of light

RBC and reticulocyte have the same laser scattering characteristics at 0

and 10 degrees. But Illuminated with polarized light at 90 degrees,
reticulocytes have different light scattering characteristics, so they can be
distinguished. When optical signal transforms to electrical signal, it can be
distinguished in scatter diagram visually.

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Figure 5-8 RTIC scatter diagram

5.7.4 RETIC_ABS

RETIC_ABS is the concentration of RETIC. It equals to the ratio of RETIC

to RBC multiplies by RBC concentration:

5.7.5 IRF
IRF has more RNA than mature reticulocytes and absorb more stain. So
their wide-angle scattering light signal is larger. IRF is classified as
reticulocyte population which exceeds preconcerted scattering threshold, as
the purple part in Figure 5-8.
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The IRF was initially designated as the Reticulocyte Maturation Index

(RMI), and defined by NCCLS H44-A 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.

1) Monitor hemopoietic regeneration after bone marrow transplant,

hemopoietic stem cell transplantation, or intensive chemotherapy

2) Monitor bone marrow toxic insults from drugs (for example, AZT)

3) Monitor erythropoietin therapy in renal failure, AIDS, infants,

myelodysplastic syndromes and blood donations

4) Classify anemia

5) Monitor efficacy of anemia therapy (Fe, B12 and Folate

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 Chapter 6 Settings

6. Settings

6.1 Overview
Initialization setting of NCC-61 has been done before delivery. Setting of
the interface at the first boot is default. To meet the different needs, some
parameters can be reset.

6.2 Settings
Click “Setup” to enter setting interface, see Figure 6-1.

Figure 6-1 Setup Interface

6.3 System Maintenance

Click “Maintence” to enter maintenance interface, see Figure 6-2.

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Figure 6-2 Maintenance

Change lyse: click “Change Lyse” to primes lyse automatically after

replacement.

Change diluent: click “Change Diluent” to primes diluent automatically

after replacement.

Change detergent: click “Change Detergent” to primes detergent

automatically after replacement.

Change sheath: click “Change Sheath” to primes sheath automatically

after replacement.
  
Cauterize aperture: click this button to eliminate clogging

Flush aperture: click this button to eliminate clogging.

Soak impedance transducer: click this button as it plugging or getting

high blank test result.

Soak sheath flow regulator: click this button to clean inner wall of sheath
flow regulator.

Empty transducer：click this button to empty the transducer

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 Chapter 6 Settings

Rinse impedance channel: click it to clean the impedance channels.

Rinse optics channel: click it to clean the optical channels.

Prepare shipping: perform this function before shipping or unused for a

long time to empty fluid in the tubing.

6.4 X-B QC
Click “X-B QC” to enter QC interface. Please refer to Chapter 7 for
details.

6.5 X-R QC

Click “X-R QC” to enter QC interface. Please refer to Chapter 7 for

details.

6.6 X QC

Click “X QC” to enter QC interface. Please refer to Chapter 7 for details.

6.7 Limit

Click “Limit” to enter the interface. See Figure 6-3.

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 Chapter 6 Settings

Figure 6-3 Limits

Click “Group” to choose patient group, male, female, children, newborns,

infants, user1, user 2 and user 3. See Figure 6-4.

Figure 6-4 Limits

Click “Default” to revert to factory settings, for example, click “Default” in

group of Male, “Male” limits reverts to factory settings.

Click “OK” to save current edited limits.

Click “Export” to export current group limits.

Click “Print” to print current group limits.

Click “Back” to go back to setup interface.

6.8 Time
 Click “Time” to set it.

There are three formats of date, which are YYYY-MM-DD, MM-DD-YYYY

and DD-MM-YYYY. Y indicates Year, M indicates Month and D indicates Day.
See Figure 6-5.

Date display format changes according to date format.

Click “OK” to save modified settings.

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 Chapter 6 Settings

Figure 6-5 Time and Date

6.9 Parameter

Click “Parameter” to enter the interface. See Figure 6-6.

Choose unit of WBC, RBC, PLT and HGB/MCHC and modify the reaction
time of RRBC. Click “Default” to revert RRBC reaction time to factory settings.
Click “OK” to save modified settings.

Figure 6-6 Parameters

6.10 Print

Click “Print” to enter the interface. See Figure 6-7.

Printer type: USB port printer (A5), USB port printer (A4)
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 Chapter 6 Settings

Print format: print with histogram, print without histogram

Auto print: open/close auto print. If it’s open, test result is auto printed
after counting. If it’s closed, it needs to manual print.

Printer title: input hospital name here, hospital name displays in printed
report title. Click “OK” to save the modified settings.

Figure 6-7 Print

6.11 Transmit
   
Click “Transmit” to enter the interface as shown in Figure 6-8.

Set the local IP, server IP, local mask, local gateway and port number as
connecting with LIS system. The native mask and the local gateway can be
selected by default, the others shall be reset.

Select either “On” or “Off” auto transmit as connecting with LIS system. “Trans
Histo” and “Trans Scatter” can be selected.

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 Chapter 6 Settings

Figure 6-8 Transmit

6.12 Maint.Set

Click “Maint.Set” to enter the interface. See Figure 6-9.

Figure 6-9 Maintenance

  
Auto blank: click to select “On” or “Off” and then click “OK” to save

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 Chapter 6 Settings

settings as blank test is necessary in each boot. The analyzer does not
perform it if it is “Off”.

Auto clean: the analyzer does not perform it if it is “Off”. Click to

select “Auto clean” and choose times (50 times, 75 times, 100 times, 125
times and 150 times) according to your necessary. Auto clean is performed
after 50 sample testing, if 50 times is selected. If shut down the analyzer in
the condition of sample test times being less than 50, the analyzer shall
re-count after rebooting.

Diluent reminders: dialog box pops up in each counting if “On” is

selected.

Auto sleep: the analyzer automatically enters the dormant state without
any operation for an interval of time. Users can adjust dormancy length
according to the necessary.

Soak and exit: prompts do not pop up if “ Off” is selected. Soak is

performed when shutting down, if “On” is selected. The analyzer prompts to
put the detergent under the aspiration probe which absorbs it to soak sample
cup. Shut down the analyzer after soaking.

Auto soak: click to choose counting times. The analyzer reminds

users of putting detergent under the sample probe and absorb it to soak
sample cup, when counting times is over selected times.

6.13 Version
Click “Version” to pop up version dialog. See Figure 6-10.

The current version information displays here. Version upgrade can be

achieved

Click “Back” to return to setup interface.

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 Chapter 6 Settings

Figure 6-10 Version Information

6.14 User

Click “User” to enter the interface. See Figure 6-11.

Figure 6-11 User

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 Chapter 6 Settings

Click “Delete” to delete selected user.

Click “Add” to pop up “Add user” dialog to edit new user’s name,
password and group. “Group” is divided into “Ordinary user” and
“Administrator”, which are given different permissions. The administrator's
permissions are higher than the Ordinary user’s. The administrator can
operate all the functions, while the general user can not delete data, use the
export function or calibrate the analyzer. See Figure 6-12.

Figure 6-12 Add User

6.15 Service

Click “Service” to pop up the following dialog. Only the NeoMedica

service engineers can perform this function in maintenance.

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 Chapter 6 Settings

Figure 6-13 Service

6.16 Reagent

Click “Setup” as changing reagent. Click “Reagent” to pop up below

dialog. See Figure 6-14.

The activation date, reagent amount, valid period of lyse, sheath, diluents
and detergent. For example, click “Change” of diluent to change diluent, see
the popup dialog in Figure 6-15.

Take out the diluent activation card from the diluent container and click
“Activate”. 15 seconds countdown starts. Put the IC card onto card reader and
hear a "tick" sound, which means successful card read. Successful activation
displays in dialog box. The activation date is the current date after activating.
The valid period is three months. The reagent balance is the current
maximum reagent dose. The remaining amount subtracts the amount
consumed by the analyzer during operation. The activation method of other
reagents is the same as diluent’s.

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 Chapter 6 Settings

Figure 6-14 Reagents

Figure 6-15 Activation

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 Chapter 6 Settings

6.17 System Log

Click ”System log”，we can check the warnings and the status of the
instrument and so on.See figure 6-16.

figure 6-16 System log

6.18Display

Click “Display” to choose the parameters to display or pint ,this depend on

our requirement.See figure:6-17.

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 Chapter 6 Settings

figure6-17 Display

CAUTION

Transmit setup 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 engineers.

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 Chapter7 Daily Operation

7. Daily Operation
7.1 Overview
This chapter describes the whole procedures of daily operation from
startup to shutoff, and explains the process of different modes of sample
analysis in detail.

Daily Operation Flow Chart as follows:

CAUTION

⮚ The analyzer must be operated by medical inspection professionals,

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trained doctors and technicians.

7.2 Preparations
Check the analyzer as the following steps before startup.

1. Check the Waste Container

The waste should be processed properly and cleaned up before startup

every day.

2. Check the Reagents, Tubing and Power

Ensure diluent, lyse, detergent and sheath meet the test requirements.

Ensure the tubing of reagents and waste connected well and without
bending.

Ensure the power plugs of instrument, computer and outlet connection is

reliable.

3. Check the Printer

Ensure printing paper is sufficient and the installation is proper.

Ensure the power is on and the cable has been connected with the
analyzer and the computer properly.

WARNING

⮚ All clinical specimens, control materials, calibrators and waste with

potentially infectious hazard. The operator should comply with the safe
operation provisions in laboratory and wear personal protective equipment
(lab coats, gloves etc.) when handling these materials.

7.3 Startup
Turn on the power switch on the left panel, then the status indicator on
the front panel turns orange. The analyzer automatically checks the operation
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of the components when self-checking and initialization after loading. Then it

rinses the flow system. It takes about 4 minutes to finish this process. Status
indicator turns blue after initiation. See Figure 7-1.

Figure 7-1 Login

  Virtual keyboard pops up as entering password and user’s name. See

Figure 7-2.

Figure 7-2 Virtual keyboard

The analyzer enters test interface after entering password and user’s
name. See Figure 7-3.

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Figure 7-3 Test Interface

After startup, blank test should be done before sample test. Operator can
 set
to run it automatically after startup, see Chapter 6 Settings for details. The
acceptable range of blank test is listed in Table 7-1.

Table 7-1 Range of blank Test

Parameter Acceptable range

WBC ≤0.20x10∧9 /L

RBC ≤0.02x10∧12 /L

HGB ≤1g /L

PLT ≤10.0x10∧9 /L

If the blank result is out of this range, please repeat the above procedures
until it is in this range. If the results are still out of this range after repeating
five times, please refer to Section 11.4.2 of Chapter 11 Troubleshooting.

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7.4 Quality Control

Quality Control should be performed before daily test for accurate results.
Please refer to Chapter 8 Quality Control.。

7.5 Collection of Blood Samples

WARNING

⮚ Considering all the clinical specimens, control materials and calibrators

that contain human blood or serum as being potentially infectious, wear
lab coats, gloves and safety glasses and follow required laboratory or
clinical procedures when handling these materials.

⮚ Do not directly contact blood samples, control materials or calibrators.

Please follow required procedures when disposing.

CAUTION

⮚ Blood collection and disposal should be performed according to the local

and national environmental regulations or laboratory’s requirements.

⮚ Ensure the whole procedure of blood collection is clean and

contamination-free. All specimens must be properly collected in tubes
containing the EDTA (EDTA-K2·2H2O) anticoagulant.

⮚ Do not shake the sample tube violently.

⮚ Venous blood can only be stored for 4 hours at room temperature.

NeoMedica recommends the blood sample be kept at the temperature
between 2℃~8℃ for longer storage.
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7.5.1 Whole blood collection

Collect whole blood sample by vein-puncture and store it in a clean
  sample tube which contains EDTA-K2·2H2O (1.5~2.2mg/mL). The
EDTA-K2·2H2O which keeps the configuration of WBC and RBC inhibits PLT
aggregation. Gently shake the tube 5~10 times and ensure to mix it 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.

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7.5.2 Diluent Sample Preparation

1． Set the current test mode to “Diluent” in “Test” interface, as shown in
Figure 7-4.

Figure7-4 Mode Switch operations

2． Take a clean test tube under the aspiration probe, press “Drain” button
on front panel. The system automatically drains 500 μL diluent from
aspiration probe. It is recommended to put the test tube close to the
aspiration probe, so as to avoid bubbles or spillage.

3． Please quickly inject 20uL peripheral blood into the test tube filled with
diluents and mix it well.

CAUTION

⮚ Avoid the collected diluent mixing with dust; otherwise it may cause
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.

⮚ Each laboratory should according to their respective sample number,

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sampling method and the technical level to evaluate the stability of the
results under the diluent 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 mixed well,
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 New Next Blood Sample

  User can either input detailed sample information before sample analysis
or after sample analysis. See Figure 7-5.

Figure7-5 New Next Blood Sample

The system comes with English input method, clicking on the

corresponding input box shall pop up the virtual keyboard. If necessary, the
user can connect to external PS2 or USB interface keyboard to help enter the
information. See Figure 7-6.

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Figure7-6 Virtual keyboard

  Name: input patients’ name

Gender:
   male and female, the default is blank if not selected.
Age: year, month, day and hour can be selected.
Blood Type: A, B, O, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-,
O Rh+ and O Rh- can be selected. The default is blank if not selected.
Group: divided into male, female, Children, infants, newborns, general,
user1, user2 and user3.

System automatically selects corresponding group as age and gender

are input. The reference values are listed as Table 7-2.

Table 7-2 Reference Value

Reference Value Age Gender

 
General NO input Blank, Male, Female

General ≥16 years Blank

Male ≥16 years Male

Female ≥16 years Female

Children >1 month and ＜16 Blank, Male, Female

years

Infants >1 month and ＜1 Blank, Male, Female

years

Newborns <1 month Blank, Male, Female

ID: only numbers can be input here. If there’s no SN input, the analyzer
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