PHOENIX NCC-3300
Automated Hematology Analyzer

User Manual

V15.05 eng 
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.
  
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CONTENTS 
GUIDANCE ............................................................................................................................................... 9 
CHAPTER 1 SYSTEM DESCRIPTION ........................................................................................................ 10 
1.1 Overview ..................................................................................................................................... 10 
1.1.1 Function ............................................................................................................................... 10 
1.1.2 Intended Use ........................................................................................................................ 10 
1.1.3 Front Panel ........................................................................................................................... 11 
1.1.4 Rear Panel ................................................................................................................................ 15 
1.2 Parameters .................................................................................................................................. 16 
1.3 Structure ..................................................................................................................................... 17 
1.3.1 Flow System ......................................................................................................................... 17 
1.3.2 Electrical System .................................................................................................................. 17 
1.3.2.1 FPGA Board ....................................................................................................................... 17 
1.3.2.2 WBC Metering Assembly .................................................................................................. 17 
1.3.2.3 RBC/PLT Metering  Assembly ............................................................................................ 18 
1.3.3 Display .................................................................................................................................. 18 
1.4 Accessory .................................................................................................................................... 18 
1.5 Sample Volume ........................................................................................................................... 18 
1.6 Reagent Volume for Single sample ............................................................................................. 19 
1.7 Test Speed ................................................................................................................................... 19 
1.8 Storage ........................................................................................................................................ 19 
1.9 Background Test .......................................................................................................................... 19 
1.10 Carryover ................................................................................................................................... 19 
1.11 Accuracy .................................................................................................................................... 19 
1.12 Precision .................................................................................................................................... 20 
1.13 Linearity .................................................................................................................................... 20 
1.14 Transport and Storage Specifications ....................................................................................... 20 
1.15 Environment Requirement ....................................................................................................... 20 
1.16 Electrical Requirement .............................................................................................................. 21 
1.17 Reagent ..................................................................................................................................... 21 
1.17.1 Diluent ................................................................................................................................ 21 
1.17.2 Lyse .................................................................................................................................... 21 
1.17.3 Detergent ........................................................................................................................... 22 
  
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1.17.4 Probe Detergent ................................................................................................................ 22 
1.17.5 Note of Reagent Use .......................................................................................................... 22 
1.17.8 Reagent Storage ................................................................................................................. 23 
CHAPTER 2 PRINCIPLES OF OPERATION ................................................................................................ 23 
2.1 PRINCIPLES OF MEASURING ........................................................................................................... 23 
2.1.1 Electrical Impedance Method .................................................................................................. 23 
2.1.2 HGB Colorimetric Method ....................................................................................................... 25 
2.2 REAGENTS FUNCTION ..................................................................................................................... 25 
2.3 CALCULATION OF PARAMETERS ..................................................................................................... 25 
CHAPTER 3 INSTALLATION AND SPECIMEN  ANALYSIS ......................................................................... 27 
3.1 UNPACKING AND INSPECTION ........................................................................................................ 27 
3.2 INSTALLATION REQUIREMENTS ...................................................................................................... 27 
3.3 POWER SUPPLY INSPECTION........................................................................................................... 28 
3.4 TUBING INSTALLATION ................................................................................................................... 28 
3.4.1 LYSE Tubing Installation ........................................................................................................... 29 
3.4.2 DILUENT Tubing Installation .................................................................................................... 29 
3.4.3 WASTE Tubing Installation ....................................................................................................... 29 
3.4.4 DETERGENT Tubing Installation ............................................................................................... 29 
3.5 PRINTER INSTALLATION (OPTIONAL) .............................................................................................. 30 
3.6 KEYBOARD AND MOUSE INSTALLATION ......................................................................................... 30 
3.7 POWER CONNECTION ..................................................................................................................... 30 
3.8 STARTUP .......................................................................................................................................... 30 
3.9 BACKGROUND TEST ........................................................................................................................ 31 
3.10 QUALITY CONTROL ........................................................................................................................ 32 
3.11 CALIBRATION ................................................................................................................................. 32 
3.12 COLLECTION OF BLOOD SAMPLE .................................................................................................. 32 
3.12.1 Venous Blood Collection ........................................................................................................ 33 
3.12.2 Peripheral Blood Collection ............................................................................................... 33 
3.13 MODE SWITCH .............................................................................................................................. 33 
3.14 SAMPLE COUNTING AND ANALYSIS .............................................................................................. 33 
3.14.1 Information Input ................................................................................................................... 33 
3.14.2 Counting and Analysis ............................................................................................................ 35 
3.14.3 Special Function ..................................................................................................................... 36 
3.14.3.1 Parameter Alarm ............................................................................................................. 36 
  
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3.14.3.2 Histogram Alarm ............................................................................................................. 36 
3.16 REPORT OUTPUT ........................................................................................................................... 38 
3.17 RESULT MODIFICATION................................................................................................................. 38 
3.18 Shutdown .................................................................................................................................. 40 
3.19 Data Query ................................................................................................................................ 40 
3.19.1 Selection, Browse, Modification and Output of Data ........................................................ 42 
3.19.2 Data Deletion ..................................................................................................................... 43 
3.19.3 Workload Statistics ............................................................................................................ 44 
3.20 Special Function ........................................................................................................................ 45 
3.20.1 Precision Counting ............................................................................................................. 45 
3.20.1.1 Select Sample Results ..................................................................................................... 45 
3.20.1.2 Check Precision ............................................................................................................... 45 
3.20.2 Trend Graph ....................................................................................................................... 46 
CHAPTER 4 SOFT KEYBOARD ................................................................................................................. 50 
4.1 Soft Keyboard Introduction ......................................................................................................... 50 
4.2 Function ...................................................................................................................................... 51 
4.2.1 Data Edit ............................................................................................................................... 51 
4.2.2 Condition Query ................................................................................................................... 52 
4.2.3 parameter Limit setting ....................................................................................................... 53 
4.2.4 L‐J QC Edit ............................................................................................................................ 54 
4.2.5 X‐B QC Edit ........................................................................................................................... 55 
4.2.6 X QC Edit............................................................................................................................... 56 
4.2.7 Manual Calibration ............................................................................................................... 57 
4.2.8 Automatic Calibration .......................................................................................................... 58 
4.2.9 System Setting...................................................................................................................... 59 
4.2.10 Service ................................................................................................................................ 60 
CHAPTER 5 SYSTEM SETTING ................................................................................................................ 62 
5.1 System Maintenance .................................................................................................................. 62 
5.2 Transfer Setting ........................................................................................................................... 63 
5.3 Print Setting ................................................................................................................................ 64 
5.4 Parameter Setting ....................................................................................................................... 65 
5.5 Date/Time Setting ....................................................................................................................... 66 
5.6 System Version ............................................................................................................................ 67 
CHAPTER 6 QUALITY CONTROL ............................................................................................................. 68 
  
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6.1 Quality Control Options .............................................................................................................. 68 
6.2 QC Operation .............................................................................................................................. 69 
6.2.1 QC Mode Select .................................................................................................................... 69 
6.2.2 L‐J QC .................................................................................................................................... 70 
6.2.2.1 L‐J QC Edit ......................................................................................................................... 71 
6.2.2.2 L‐J QC Run ......................................................................................................................... 72 
6.2.2.3 LJ QC Review ..................................................................................................................... 73 
6.2.3 X QC ...................................................................................................................................... 75 
6.2.3.1 X QC Edit ........................................................................................................................... 75 
6.2.3.2 X QC Run ........................................................................................................................... 76 
6.2.3.3  QC Review ........................................................................................................................ 77 
6.2.4 X‐R QC .................................................................................................................................. 79 
6.2.4.1 X‐R QC Run ........................................................................................................................ 79 
6.2.4.2 X ‐R QC Review .................................................................................................................. 80 
6.2.5 X‐B QC .................................................................................................................................. 83 
6.2.5.1 X‐B QC Edit ........................................................................................................................ 83 
6.2.5.2 X‐B QC Run ........................................................................................................................ 84 
6.2.5.3 X‐B QC Review ................................................................................................................... 85 
CHAPTER 7 CALIBRATION ...................................................................................................................... 88 
7.1 Preparation for Calibration ......................................................................................................... 89 
7.3 Auto Calibration .......................................................................................................................... 91 
CHAPTER 8 PARAMETER LIMIT ............................................................................................................. 93 
8.1 Limit Review ................................................................................................................................ 93 
8.2 Limit Modification ....................................................................................................................... 95 
8.3 Print ............................................................................................................................................. 95 
CHAPTER 9 MAINTENANCE ................................................................................................................... 96 
9.1 Daily Maintenance ...................................................................................................................... 96 
9.2 Weekly Maintenance .................................................................................................................. 97 
9.2.1 Surface Maintenance ........................................................................................................... 97 
9.3 Monthly Maintenance ................................................................................................................ 98 
9.4 System Maintenance .................................................................................................................. 98 
9.4.1 Cauterize Aperture ............................................................................................................... 99 
9.4.2 Flush Aperture...................................................................................................................... 99 
9.4.3 Drain Cups ............................................................................................................................ 99 
  
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9.4.4 Rinse Cups .......................................................................................................................... 100 
9.4.5 Rinse Fluidics ...................................................................................................................... 100 
9.4.6 Prime Lyse .......................................................................................................................... 101 
9.5 Maintenance before Shipping ................................................................................................... 102 
CHAPTER 10 SERVICE .......................................................................................................................... 104 
10.1 System Check .......................................................................................................................... 104 
10.1.1 System Status Check ............................................................................................................ 104 
10.1.2 Valve Check ...................................................................................................................... 105 
10.1.3 Motor Check..................................................................................................................... 107 
10.2 System Log .............................................................................................................................. 108 
10.2.1 System Log Query Mode .................................................................................................. 109 
CHAPTER 11 TROUBLESHOOTING ....................................................................................................... 112 
11.1 Troubleshooting Guidance ...................................................................................................... 112 
11.2 Obtaining Technical Assistance ............................................................................................... 113 
11.3 Troubleshooting ...................................................................................................................... 113 
11.4.1 Faults Related to Reagents .............................................................................................. 114 
11.3.2 Faults Relate to Vacuum .................................................................................................. 114 
11.3.3 Faults Relate to 5V Voltage .............................................................................................. 115 
11.3.4 Faults Relate to Test Results ............................................................................................ 115 
11.3.5 Faults Relate to Hardware ............................................................................................... 116 
11.3.6 Faults Relate to Temperature .......................................................................................... 116 
CHAPTER 12 PRECAUTINOS, LIMITATIONS AND HAZARDS ................................................................. 117 
12.1 Limitations ............................................................................................................................... 117 
12.2 Location Limitations ................................................................................................................ 117 
12.3 Personal Protection and Infection Control ............................................................................. 118 
APPENDIX A: INSTRUMENT SPECIFICATIONS ...................................................................................... 119 
APPENDIX B: INSTRUMENT ICONS AND SYMBOLS ............................................................................. 122 
APPENDIX C: COMMUNICATION ......................................................................................................... 123 
1. HEXADECIMAL FORMAT COMMUNICATION .................................................................................. 123 
1.1 Data Link MAC Sublayer Parameters Convention ..................................................................... 123 
1.2 Data Link Layer Frame Format .................................................................................................. 123 
1.2.1 Frame Format ..................................................................................................................... 123 
1.2.2 Meaning of Fields or Control Fields ................................................................................... 123 
1.2.3 Convention ......................................................................................................................... 124 
  
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1.3 Message Field Structure ............................................................................................................ 124 
1.3.1 Message Structure ............................................................................................................. 124 
1.3.2 DATA Field Definition ......................................................................................................... 124 
2. ASCII FORMAT COMMUNICATION .................................................................................................. 125 
2.1 Message Transfer Format ......................................................................................................... 125 
2.2 Massage Grammar .................................................................................................................... 125 
2.3 Data Type .................................................................................................................................. 125 
2.4 Message Type ........................................................................................................................... 126 
  
  
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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-3300 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-3300 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-3300 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.
  
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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
  
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GUIDANCE 

General information for the operation of the analyzer is contained in this manual, which
covers the best guidance for a new operator to master the characteristics of the ainstrument
and operation methods, as well as for daily inquiry. Do peruse before first operation.

This manual uses the following warning conventions:

WARNING: Denotes a hazard which, if not avoided, could result in moderate to serious
injury.

CAUTION: Denotes potential hazards that could result in a minor injury, also used for
condition or activities which could interfere with proper function of the analyzer.

NOTE: Denotes special operator/service infoermation or standard practices

Do read trough this manual before operation, maintenance, displacement to the

analyzer.

 
  
  Page 10
 

CHAPTER 1 SYSTEM DESCRIPTION 
 

1.1 Overview 
This is multi-parameters, automated hematology analyzer designed for in vitro
diagnostic use. It gives accurate test data of human blood cells as the necessary
reference of clinical diagnosis.

1.1.1 Function 
The automated hematology analyzer adopt Coulter electrical impedance and
colorimetry methods to obtain test data of WBC, RBC, PLT, HGB and other
parameters. Meanwhile analyzer gives 3 differentials of WBC and provides histogram
informations.

1.1.2 Intended Use 
The automated hematology analyzer is appropriate to the qualitative and quantitative
analysis of the visible components in human beings blood.

 
  
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1.1.3 Front Panel 
 

3 2

Figure 1-1 Front Panel

1. Aspiration Probe
Aspirate samples.
2. RUN Key
Press the RUN key to startup the aspiration probe and then analyze specimen
only in the screens of main menu or Quality Control. At other screens, the RUN
key is invalid.
3. Recorder
Print the test result.

4. Touch Screen
10.4 inch LCD. The screen is divided into 5 areas as shown in Figure 1-2.
  
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Figure 1-2 Screen

• Prompt Information
Display the prompt information.
• Mode
Display the work mode: whole blood mode or pre-diluent mode.
• System Time
Display the system date and time.
• Test Result
Display the test result.
• Menu
Display functional menus which fall into two categories.
First category menu is displayed across the bottom of the main
menu screen as shown in Figure 1-3.
  
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Figure 1-3 Main Menu Screen

Func: Direct to second category menus.

Info: Direct to next specimenn’s information-input window.
Rev: Direct to query stored specimens data.
Histo: Direct to histogram-modification window of the current specimen.
Drain: Dispens the diluent from the aspiration probe, mainly used for pre-diluent mode.
Trans: Transmit specimen data to the network.
Print: Print the specimen data.
Mute: Mute the alert sound.
Help: Direct to system help window.
Exit: Click „Exit”, „Thank you, now turn off power” will appear to instruct the operator to
turn off the power switch on the rear panel.

Second category meny is shown in Figure 1-4:

Figure 1-4 Function Menu

  
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Back: Return to the first category menus.
Maint.: Direct to maintain screen to perform operations of flush, prime, cautery, etc.
Limit: Direct to limit-setting screen to modify the liits of parameters.
Stast.: Calculate the workload during a certain time.
QC: Direct to quality-control window to process QC.
Cal.: Direct to calibration window to calibrate the analyzer.
Setup: Direct to setup window to reset parameters.
Sev.: Direct to service window to process self-check and maintenance.
Help: Direct to system help window.
  
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1.1.4 Rear Panel 

 
Figure 1-6 Rear Panel
1.COMI and COM2
Connect to the standard RS-232 network.
2. PRINTER
Connect to the printers
3.USB Port
Connect to USB equipment.
4. PS2 port
Connect to the keyboard and mouse.
5. Grounding Terminal
It's used to ground the analyzer.
6.Fan
It is for the heat dissipation of power supply.
7.Power Receptacle
Connect to the main power cord to the analyzer.
8.Power Switch
Turn the power supply on or off.
9.SENSOR
Connect to the waste sensor
10. DETERGENT
Detergent port connect to the detergent inlet tube.
11. WASTE
Waste port connect to the waste outlet tube
  
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12. LYSE
Lyse port connect to the lyse inlet tube.
13. DILUENT
Diluent port connect to the diluent inlet tube.

1.2 Parameters 
Analyzer can automatically analyze the sample data, differentiates WBCs into 3
differentials and display 21 parameters and 3 histograms of WBC, RBC and PLT. Refer
to Table 1-1 for details of 21 parameters.

Table 1-1 21parameters

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

  
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PCT Plateletcrit %

P_LCR Large Platelet Percent %

P_LCC Large Platelet 109cells/L

1.3 Structure 
The automated hematology analyzer consists of a host, accessories and an external
printer (optional). A host mainly includes FPGA board, WBC metering assembly,
RBC/PLT metering assembly, flow system and a touch screen etc. Accessories include
power cord and grounding cord.

1.3.1 Flow System 
The flow system is composed of solenoid valves, a vacuum pump, a force pumpe, a vacuum
chamber and plastic tubes.

Solenoid Valve --- These contact two-way or tree-way solenoid valves control the flow of
reagent.

Vacuum Pump --- Pump the waste generated in the processing out to the analyzer and
produce negative pressure.

Force Pump --- Provide positive pressure for reverse clean and lyse mixture.

Vacuum Chamber --- Generate negative pressure and play the role of temporary waste
reservoir.

Plastic Tube --- Reagent and waste flow in the plastic tube.

1.3.2 Electrical System 

1.3.2.1 FPGA Board 
FPGA board is the control center of the analyzer, it controls the following components and
their movement:

• All the valves open and close, reagent aspiration, rinse and waste discharge.

• Run force pump and vacuum pump to offer power to mix reagent, eliminate clog,
aspirate and discharge reagents.

• Control step motors to aspirate sample and reagent.

• Control the A/D conversion of WBC, RBC/PLT and HGB; provide previous service for
the computer’s data processing; check all optical and electrical switch movements.

1.3.2.2 WBC Metering Assembly 
WBC metering assembly is composed of a signal collection board, electrodes, a micro-
aperture sensor and flow system etc..
  
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• Signal Collection Board --- It provides constant current for electrodes. Then
amplifies and deals with the collected pulse signals for mainboard.

• Electrode --- There are two electrodes in WBC metering assembly. One is located
within WBC cup, and the other one is outer. Both electrodes are submerged in the
conductive liquid, creating an electrical pathway trough the micro-aperture.

• Micro-aperture Sensor --- Micro-aperture sensor is mounted an the front end of

WBC cup. Particles pass trough the aperture whose diameter is 100µm when
processing a sample.

• Flow System --- The flow system uses negative pressure to aspirate diluent,
detergent and sample from each container into metering tube, and discharge waste
at the end of the processing. The step motor controlled by mainboard runs to add
specific volume lyse into WBC cup, then mix it by the air created by force pump.

1.3.2.3 RBC/PLT Metering  Assembly 
RBC/PLT Metering Assembly is composed of a signal collection board, electrodes, a micro-
aperture sensor and flow system etc..

• Signal Collection Board --- It provides constant current for electrodes. Then
amplifies and deals with the collected pulse signals for mainboard.

• Electrode --- There are two electrodes in RBC/PLT metering assembly. One is
located within RBC/PLT cup, and the other one is outer. Both electrodes are
submerged in the conductive liquid, creating an electrical pathway trough the micro-
aperture.

• Micro-aperture Sensor --- Micro-aperture sensor is mounted an the front end of

RBC/PLT cup. Particles pass trough the aperture whose diameter is 68µm when
processing a sample.

• Flow System --- The flow system uses negative pressure to aspirate diluent,
detergent and sample from each container into metering tube, and discharge waste
at the end of the processing.

1.3.3 Display 
The automated hematology analyzer uses a 10.4-inch LCD which can display 21 parameters
and 3 histograms.

1.4 Accessory 
The accessory of the analyzer include power cord, grounding cord, external printer
(optional), etc...

1.5 Sample Volume 
Whole Blood Mode for Venous Blood: Venous Blood 10µL

Pre-diluent Mode for Peripheral Blood: Capillary Blood 20µL

Whole Blood Mode for peripheral Blood: Capillary Blood 10µL

  
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1.6 Reagent Volume for Single sample 
Diluent: 31mL

Detergent: 8mL

Lyse: 0.7mL

NOTE: Reagent consumption is various according to the software version.

1.7 Test Speed 
The automated hematology analyzer is able to process at least 60 samples per hour. 

1.8 Storage 
The automated hematology analyzer is equipped with a memory which can store
100.000 samples data.

1.9 Background Test 
WBC≤0.2x109/L; RBC≤0.02x109/L; HGB≤1g/L; PLT≤10x109/L

1.10 Carryover 
WBC≤0.5%; RBC≤0.5%; HGB≤0.5%; HCT≤0.5%; PLT≤0.5%

1.11 Accuracy 
The accuracy of analyzer should be complied with Table 1-2

Table 1-2 Accuracy

Measurement item AcceptableLimits

WBC ≤±2.0％
RBC ≤±1.5％
HGB ≤±1.5％
MCV ≤±0.5％
HCT ≤±1.0％
PLT ≤±4.0％
 

 
 

 
  
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1.12 Precision 
Table 1-3 Precision

Parameter Acceptable Limits Precision Range

(CV %)
WBC ≤2.0 % 4.0x109/L – 15.0x109/L
RBC ≤1.5% 3.00x1012/L -6.00x1012/L
HGB ≤1.5% 100g/L - 180g/L
HCT ≤2.0% 35% - 50%
MCV ≤1.0% 76fL – 110fL
PLT ≤5.0% 100x109/L – 500x109/L
 

1.13 Linearity 

The linearity of analyzer should be conformed to Table 1-4.

Table 1 4 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%
 

1.14 Transport and Storage Specifications 

1) Temperature: 10°C ~ 55°C

2) Relative Humidity: ≤95%RH
3) Barometric Presssure: 50kPa~106kPa

1.15 Environment Requirement 

1) Temperature: 15 ~35°C
2) Relative Humidity: ≤90%RH
3) Barometric Pressure: 60kPa~106kPa
  
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1.16 Electrical Requirement 
 

1) Power Supply: AC 100V÷240V

2) Frequency: 50/60Hz
3) Power: 100VA-180VA
4) Fuse: 250V/3A

1.17 Reagent 
The reagent is configured specifically for the PHOENIX NCC-3300 flow systems in order to
provide optimal system performance. Each PHOENIX NCC-3300 is checked at the factory
using the specified reagents and all performance claims were generated using these
reagents. Thus non-NEOMEDICA reagents will lead to defects in the performance of the
analyzer and serious mistakes, even accidents.

NOTE

¾ Reagents must be stored at room temperature to ensure optimal performance. All

reagents should be protected from direct sunlight, undercooling and overheating during
storage.
¾ The background test should be done after the replacement of diluent, lyse and detergent
to ensure it is within the normal range.
¾ The reagent inlet tubes have a cap attached that minimizes evaporation and
contamination during use. The pipe can only insert reagent through the cap. Please
close the cap tightly.
¾ Ensure all reagents to be used in validity period.

1.17.1 Diluent 
Diluent is a kind of reliable isotonic diluent to meet the requirements as follows:
(1) Dilute WBC, RBC, PLT, HGB.
(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 ℃, 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.

1.17.2 Lyse 
Lyse is a new reagent without azide (NaN3 complex) and cyanide and meets the
requirements as follows:
  
  Page 22
 
(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 ℃, 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.

1.17.3 Detergent 
Detergent contains the active enzyme to clean the agglomerated proteins in the WBC, RBC
probes, the WBC, RBC cups and measurment devices.
Storage and service life after opening: Please store it in a cool dry place under 5-35℃. Away
from direct sunlight, or ingredients of detergent will be invalid as the exposure time goes on.
Once opened (connected to the instrument), the product shelf life is only 60 days.

1.17.4 Probe Detergent 
Probe detergent contains effective oxide to clean the stubbornly-blocked apertures on the
WBC, RBC probes.

1.17.5 Note of Reagent Use 

1) Using supported reagents

Appropriate reagent is necessary for normal operation, daily maintenance and
accurate results. The reagent used must match with analyzer model. The reasons are as
follows:
• Impedance method is to get the data according to cell pulse size and
setting threshold value.
• Cell pulse size is related to type, concentration and adding amount of lyse as well as
hemolysis time.
• Cell pulse size is related to osmotic pressure of diluents, ion strength and
conductivity.
• Cell pulse size is related to valve voltage, mesh current and pulse gain.

2)Please operate under professional‘s instruction..

3) Avoid contacting with skin and eyes. If does, rinse with water and seek medical
advice immediately.
4) Avoid inhaling reagent gas.

CAUTION
¾ Detergent and probe detergent is alkali cleaning agent
  
  Page 23
 
(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.

1.17.8 Reagent Storage 

1) Please store in a cool place.

2) Seal the cap of the container to avoid evaporation and contamination.
3) Avoid freeze.
4) Reagent should be used within 60 days after open, if not, dispose as waste.

CHAPTER 2 PRINCIPLES OF OPERATION 

Principles of operation of the automated hematology analyzer will be discussed in this

chapter. The two independent measurement methods are:
1) The electrical impedance method for determining the quantity and volume
of blood cell.
2) The colorimetric method for determining the content of hemoglobin.

2.1 Principles of Measuring 

The measurement is mainly on the quantity, volume of blood cells and HGB.

2.1.1 Electrical Impedance Method 

The cells are counted and sized by the electrical impedance method. As Figure
2-1 shows, this method is based on the measurement of changes in electrical
current which are produced by a particle, suspended in a conductive liquid, as
it passes through an aperture of known c:limensions. An electrode is submerged in the
liquid on either side of the aperture in order to create an electrical pathway through it.

As each particle passes through the aperture, a transitory change in the resistance between
the electrodes is produced. This change produces a measurable electrical pulse. The
number of pulses generated is indicative of the number of particles that traversed the
aperture. The amplitude of each pulse is essentially proportional to the volume of the
particle that produced it.
  
  Page 24
 

Each pulse is amplified and compared to internal reference voltage channels. These
channels are delineated by calibrated size discriminators to accept only pulses of a certain
amplitude. Thus, the pulses are sorted into various size channels according to their
amplitude.
 

Cell-flow
Direction

Iner electrode

Outer electrode

Electric liquid Aperture

Figure 2-1 Electrical Impedance Method

The size channels are basically divided into three categories by a pre-set
classification program in the analyzer as follows:

WBC 35 450 fL
RBC 30-110 fL
PLT 2-30 fL

According to the volume, WBCs handled by lyse can be subdivided into three
Categories: Lymphocyte (LYM), Monocyte (MID) and Granulocyte (GRAN).

LYM 35-98 fL
MID 99-135 fL
GRAN 136-450 fL
  
  Page 25
 
2.1.2 HGB Colorimetric Method 

Lyse added into the blood sample will crack the membrane of red blood cells promptly
and transfer into a kind of compound which can absorb the wavelength of 540 nm.
Through the comparison of the absorbance between the pure diluent and the sample,
the concentration of sample hemoglobin is calculated.

2.2 Reagents Function 

In automated hematology analyzer, counting system has a high sensitivity of the cell
volume. Cells which are suspended in conducting liquid should be protected from physical
condense and adhesion. Control the osmotic pressure of conducting liquid (mainly diluent)
and keep the structure of cells so as to minimize the volume change. Lyse can dissolve the
RBC membrane fleetly and keep the structure of WBC so that the instrument can count and
classify cells.

2.3 Calculation of Parameters 
 

All parameters of blood sample are expressed in three ways:

1) parameters generated by analyzer directly: WBC , RBC , PLT, HGB

2) parameters generated by histograms: LYM%, MID%, GRAN%, RDW_CV, RDW_SD,

MPV, PDW, P_LCR, P_LCC,.
3) parameters derived from certain formulas: LYM#, MID#, GRAN#, MCHC, PCT
The formulas are as follows:

• HCT ( % ) = RBCxMCV/10
• MCH ( pg ) = HGB/RBC
• MCHC ( g/L ) = 100xHGB/HCT
• PCT ( % ) = PLTxMPV/ 10000
• LYM ( % ) = 100xAL / ( AL+AM+AG )
• MID ( % ) = 100xAM / ( AL+AM+AG )
• GRAN ( % ) = 100xAG/ ( AL+AM+AG)
  
  Page 26
 

WBC histogram is as Figure 2-2:

Figure2-2 WBC Histogram

AL: quantity of cells in LYM area.

AM: quantity of cells in MID area.
AG: quantity of cells in GRAN area.

The calculation formulas for absolute value of lymphocyte (LYM#), monocyte

(MID#) and granulocyte (GRAN#) are as follows:
• Lymphocyte ( 109L ) LYM# = LYM%xWBC/100
• Monocyte ( 109L ) MID# = MID%x WBC/100
• Granulocyte ( 109L ) GRAN# = GRAN%xWBC /100
• RBC Distribution Width Repeat Precision ( RDW-CV ) is derived from
RBC histogram, shows the volume distribution differentiation coefficient of
RBC, with the unit of %.
• RBC Distribution Width Standard Difference CROW-SD) is derived from
RBC histogram, shows the volume distribution standard difference of RBC, with the
unit of fL.
• Platelet Distribution Width (PDW) is derived from PLT histogram, shows the
volume distribution of PLT.
• Mean Platelet Volume (MPV) is derived from PLT distribution histogram, its unit is
fL.
• P-.LCR indicates the ratio of large platelet (212 fL). It is derived from
PLT histogram. See Figure 2-3. LD,UD is the differentiating line of 2~6
fL and 12~30 fL. These two lines are decided by analyzer
automatically. P-LCR is the ratio of particles between 12 fL line and UD
to particles between LD and UD.
• P_LCC: Large platelet, it is the particles between 12 fL line and UD.
  
  Page 27
 

12fL
Figure 2-3 P-LCR

CHAPTER 3 Installation and Specimen  Analysis 
 

Installation procedures must be repeated.in conformation to this chapter if the

analyzer is moved from the original installation site.

3.1 Unpacking and Inspection 

Carefully remove the analyzer and accessories from shipping carton, keep the
kit stored for further transport or storage. Check the following:
1) Quantity of accessories according to the packing list.
2) Leakage or soakage.
3) Mechanical damage.
4) Bare lead, inserts and accessories.

3.2 Installation Requirements 
Details please refer to chapter 12 Precautions, Limitations and Hazards

WARNING: Not for home use.

WARNING: Not for therapy.
WARNING: The Power switch is used as disconnect device, the disconnect
  
  Page 28
 
device shall remain readily operable. Please do not place the instrument in the
location where is difficult to operate the disconnect device.

CAUTION: Away from direct sunlight.

CAUTION: Avoid temperature extreme.
CAUTION: Away from centrifuge, X-ray equipment, display or copier.
CAUTION: No cell phone, wireless phone and equipments with strong radiation
which will interfere with the normal operation of the analyzer.

3.3 Power Supply Inspection 

Be sure that the system is located at the desired site before attempting any connections.
See Table 3-1 for details.

Table 3-1 Power Supply Inspection

WARNING: A grounded power outlet is required to connect directly with the grounding
terminal on the rear panel. Be sure to guarantee the security of the work site.
CAUTION: A fluctuated voltage would impair performance and reliability of the
analyzer. Proper action such as the installation of E.C manostat should be taken before
operation.
CAUTION: Frequent power failure will seriously decrease the performance and
reliability of the analyzer. Proper action such as the installation of UPS should be taken
before operation.

3.4 Tubing Installation 

There are four tube-connectors on the rear panel: LYSE, DILUENT, DETERGENT and
WASTE, each of which is wrapped with a cap to avoid contamination before shipment.
Uncover and set the caps aside carefully for further use on initial installation.
  
  Page 29
 
3.4.1 LYSE Tubing Installation 

Remove the lyse tube with red faucet from reagent kit and attach it to LYSE connector
on the rear panel, place the other end into the lyse container. Twist the cap until secure.
Place the container on the same level as the analyzer.

3.4.2 DILUENT Tubing Installation 

Remove diluent tube with blue faucet from reagent kit and attach it to DILUENT connector
on rear panel. Place the other end into diluent container. Twist cap until secure. Place the
container on the same level as the analyzer.

3.4.3 WASTE Tubing Installation 

Remove the waste tube with black faucet from reagent kit and attach it to WASTE connector
on the rear panel, connect BNC plug with the socket marked "SENSOR" on the rear panel.
Twist the tube's cap clockwise onto the waste container until secure. Place the container on
the level at least 50cm lower than the analyzer.

3.4.4 DETERGENT Tubing Installation 

Remove the detergent tube with yellow faucet from reagent kit and attach it to DETERGENT
connector on the rear panel. Place the other end into the detergent container. Twist the cap until
secure. Place the container on the same level as the analyzer.
CAUTION: keep the tube in loose condition after installation, no distortion or folding.
CAUTION: All the tubes should be installed manually. Do NOT utilize any tool.
CAUTION: If any damage or leakage occurs in the reagent container, or the reagents have
exceeded expiry date, contacts Customer Support Centre for replacement.

WARNNING: The waste must be handled with biochemical or chemical methods before disposal,
or it will cause contamination to the environment. Users have obligation to follow the local and
national environmental regulations.
  
  Page 30
 
 

3.5 Printer Installation (optional) 

Take out the printer from the shipping carton. Inspect the printer carefully according to its manual
and Section 3.1 and perform the following procedures:

1) Find a suitable location adjacent to the analyzer. Location of at least 30cm away from analyzer
on its right side is recommended.
2) Assemble the printer as directed in the printer manual.

3) Connect the printer and analyzer with printer cable which plug into PRINTER or US8
on rear panel of the analyzer according to the type of printer.
4) Be sure that the printer power switch is OFF; plug the end of power cord to power
socket.
5)install printing paper as directed in the manual.

3.6 Keyboard and Mouse Installation 

Remove keyboard, mouse and mouse pad from the shipping carton, and insert the plugs of
keyboard and mouse into the two connector of the line, then connect to the rear panel with
"PS/2" port. It is recommended to place the keyboard beneath the display.

3.7 Power Connection 

Make sure the power switch is OFF (O) and the grounding terminal on the rear panel is well
grounded firstly, then connect the analyzer to the main power with the power cable.

3.8 Startup 

Turn on the power switch on the rear panel. The analyzer will start system check, self-
checking and after system is up, the analyzer starts with fluidic initialization and
automatically prime the diluent, detergent and lyse, then rinse the tubing.
The main menu screen is displayed after self-checking (See Figure 3-1).
  
  Page 31
 

Figure 3-1 Main menu Screen

3.9 Background Test 

Background test should be performed after startup and before blood sample test, operate as
follow:

1) Put the clean empty tube under the aspiration probe. At main menu screen, click the
mode switch button on the top of the screen, current mode will be switched to “Pre-diluent”
mode, then click “Drain to discharge the diluents into the tube.

2) At main menu screen, click “Info”, and then modify ID to 0, click “OK” back to save it.

3) Click “Pre-diluent” to switch to “Whole Blood” mode, put the tube containing diluents
beneath aspiration probe and ensure the probe touch the bottom of tube.

4) Press RUN key on the front panel, move away the tube after the beep sounds. Then
analyzer starts to count and measure automatically.

5) Counting time of RBC, WBC will be displayed at the lower right corner of screen during
counting. Analyzer will alarm and display the error at top left corner if counting time is too
long or too short. Refer to Chapter 11 for problem correction.

6) The acceptable range of background is listed in Table 3-2.

  
  Page 32
 

Table 3-2 Acceptable Range of Background

If the background result is out of acceptable range, repeat the above procedures until reach the
acceptable results.
NOTE: ID number of background test is set to be 0 by the software to make the result not
memorized in the analyzer.
NOTE: The ID number of blood sample test can’t be set to 0.

3.10 Quality Control 

Quality control should be performed before daily test or on the initial installation. Refer to
Chapter 6.

3.11 Calibration 

On the initial installation, if the backgroun results and quality control are normal,
recalibration is not necessary. If not and there are shifts or trends in some parameters,
recalibrate the analyzer referring to Chapter 7.

3.12 Collection of Blood Sample 

CAUTION: Consider all the clinical specimens, controls and calibrators etc 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.
CAUTION: Blood collection and disposal should be performed according to the local and
national environmental regulations or laboratory's requirements.
  
  Page 33
 
CAUTION: Be sure the blood collection clean and contamination-free. All specimens must
be properly collected in tubes containing the EDTA (EDTA-K2'2H20) anticoagulant used by
the laboratory.

CAUTION: Do not shake the sample tube violently.

NOTE: Venous blood can only be stored for 4 hours at room temperature. We recommends
the blood sample be kept at temperature between 2-8 °C for longer storage.

3.12.1 Venous Blood Collection 

Collecting whole blood sample through vein-puncture and store in a clean sample tube
with EDTA-K2·2H20, which can keep the configuration of WBC, RBC and avoid
platelets aggregation. Gently shake the tube 5~10 times to make it well mixed.

3.12.2 Peripheral Blood Collection 

Capillary blood is usually collected from finger tip. The volume of sample tube is set to
be 20µL.
CAUTION: Never over-press the finger avoiding collecting tissue liquid into sample
tube, tissue liquid will cause error in results.

3.13 Mode Switch 

In the screen as Figure 3-1 shows, click the mode switch button on the top to switch among
Whole Blood Mode for Venous Blood, Pre-diluent Mode for Peripheral Blood and Whole
Blood Mode for Peripheral Blood. Corresponding sign on screen will indicate current
operating mode..

3.14 Sample Counting and Analysis 
 

Sample counting and analysis is processed as following procedures.

3.14.1 Information Input 

ƒ Input information manually

Click "info" at main menu screen, the Info edit window present (shown in Figure 3-2), input
or select data. Click "OK" to save the input data and return to the main menu. Click "Cancel"
  
  Page 34
 
to cancel the input data and return to the main menu.

Figure 3-2 Info Edit Window 

Name: Input alphanumeric characters.

Sex: Select male or female, if not selected, default as blank.
Age: Input Year, Month and Day.
Blood : Select A, B, 0, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-. 0 Rh+, 0, Rh-.
If not selected, default as blank.
Limit: Select Auto, Man, Woman, Child, Infant~ Neonate, General, User 1, User 2, User 3. If
Auto is selected, the reference values are listed as table 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

  
  Page 35
 
ID: The ID number is in range from 00000000-99999999. If no ID input, the ID of current
sample will be automatically added follow the last one.
Sample No.: Input the sample barcode number.
Bed No.: Input bed No. of patient.
Sender: Input sender's name or code.
Dept.: Input department name or code of operator.
Checker: Input checker's name or code.
Assessor: Input assessor's name or code.

NOTE: The ID number is set to 0 only under background test. The blood sample ID CAN
NOT be 0.

3.14.2 Counting and Analysis 

Counting and analysis should be performed within 3~5 minutes after blood
collection.
ƒ Pre-diluent Mode for Peripheral Blood

1) Present the empty sample tube under the aspiration probe. At main menu screen, click "Drain";
the diluent will be dispensed into the tube.
2) Remove the tube, add 20uL of the blood sample to the tube, and gently shake the tube
to make them well mixed.
3) Present the well-mixed sample under the aspiration probe; make sure the probe touches
the tube bottom slightly.
4) Press RUN key on the front panel and remove the sample after hearing beep sound.

5) Process of analysis will take some time, please wait a moment.

ƒ Whole Blood Mode for Venous Blood

1) Gently shake the tube to well mix the blood sample, then place the sample tube beneath
the probe, make sure the probe touches tube bottom slightly.
2) Press RUN key and remove the sample after hearing beep sound.
3) Process of analysis will take some time, please wait a moment.
  
  Page 36
 
ƒ Whole Blood Mode for Peripheral Blood

1) Gently shake the tube to well mix the blood sample, then place the sample
tube beneath the probe,
2) Press RUN key and remove the sample tube after hearing beep sound.
3) Process of analysis will take some time, please wait a moment.

Test results and histograms of WBC, RBC and PLT will be displayed at main menu screen
after counting and analysis (see Figure 3-1).
If Auto Rec or Auto Print is ON (set in "system setting" screen), the test results will be
printed out automatically.
If problems like clog or bubbles occur during the counting and analysis procedures, the
analyzer will alarm and give indication at the top left corner of the screen. The test results
are invalid. Refer to Chapter 11 for solution.

3.14.3 Special Function 

There are 2 kinds of alarms: parameter alarm and histogram alarm.

3.14.3.1 Parameter Alarm 

"H" or "L" present on the right side of the parameter means the result is out of
the range of reference value.
"***" means the result is invalid or out of display range.

3.14.3.2 Histogram Alarm 

If the WBC Histogram is abnormal, R1, R2, R3, R4, RM will be displayed on the right side of
the histogram.

R1 indicates there is abnormality in the left side of LYM wave peak, which probably caused
by incomplete hemolysis of RBC, platelet clump, giant platelet, plasmodium, nucleated
RBC, abnormal lymphocyte, proteinic or fat granule.

R2 indicates there is abnormality in the area between LYM wave peak and MID wave, which
probably caused by pathologic lymphocyte, plasmocyte, atypia lymphocyte, original cell or
an increase in eosinophil and basophilia,
  
  Page 37
 

R3 indicates there is abnormality in the area between MID wave and GRAN wave peak,
which probably caused by immature granulocyte, abnormal cell subpopulation,
eosinophilia.

R4 indicates there is abnormality in the right side of GRAN wave peak, which probably
caused by an absolute increase in granulocyte.

RM indicates there are two or more preceding alarms.

When the histogram of PLT has abnormalities, PM alarm will be shown in the right side.

PM indicates there is ill-defined boundary between PLT and RBC, which probably
caused by the present of giant platelet, platelet clump, small RBC, cell debris or fibrin.

3.15 Result Analysis

We provide plenty and convenient result analysis functions.

• Click "Histo" to modify the test results. Refer to Section 3.18 in this chapter for
details.
• Click "Trans" to transmit the data to network.
• Click "Print" to print data report of current blood sample by recorder or
printer.
• Click "Mute" to mute or sound the alarm.
• Click "Help" to get necessary help.
• "H" or "L" present on the right side of the parameter means the result is out of the
range of reference value. "L" means result is lower than the lower limit while "H"
means resuIt is higher than upper limit.
• If counting time lower than system setting time, the system will alarm
"WBC bubble" or "RBC bubble", at the same time display "B" before test result.
• If counting time higher than system setting time, the system will alarm
"WBC clog" or "RBC clog", at the same time display "C" before test result.
• Because of large display of limit sequence, it should be set "None" in
System Setting for limit sequence firstly, then "L", "H", "B", "C" will appear.
  
  Page 38
 

NOTE: If Parameter value is ***, it indicates invalid data.

NOTE: If there is a PM alarm of PLT histogram , PDW probably will be ***.

NOTE: WBC differential may be incorrect if WBC is lower than 0.5x109/L. Microscope
examination is recommended.

3.16 Report Output 

The automated hematology analyzer offers recorder and printer which are optional
according to customer needs. After blood sample analysis completed, if Auto Print is ON,
test report will be printed automatically by recorder or printer; if the Auto Trans is ON, test
results will be transmitted to network automatically.

The recorder, printer and transmit are set up at Settings window. Refer to Chapter 5 for
details.

Click "Trans" to transmit data of the current sample to network.

Click "Print" to print test report of current sample by recorder or printer.

3.17 Result Modification 

If the auto-classification of floating limit for WBC, RBC and PLT do not reach clinical or
laboratory requirements on special samples, manual classification is feasible.

CAUTION: Unnecessary or incorrect manual classification will cause unreliable test results.
It is recommended to microscopic exam before clinical

The procedures are as follows:

1) At main menu screen click "Histo", then the interface as shown in Figure 3-3 will display. The
histogram of WBC has been selected and surrounded by a rectangle of red line, then click
"Param" to select WBC, RBC, PLT diagram parameters that needs modification.
  
  Page 39
 

Figure 3-3 Classification

2) Once the diagram parameter need to be modified is selected, click “Class” to select the
desired classification, then the classified line will change from white line to red line.
3) Click "Left" or "Right" to move the classified line, and the value of classified line will
be indicated at the lower right of the screen.
4) Click "Back" after modification, the dialog box as shown in Figure 3-4 will display;
click "NO" to cancel the modification, while click "YES" to save the modified
results.

Figure 3-4 Save Dialog Box

  
  Page 40
 

3.18 Shutdown 

Shutdown procedure is performed after daily operation and before turning the analyzer off.
Daily maintenance and tubing-clean avoid protein aggregation during non-working and keep
system clean. Shutdown procedure is as follows:
1) At main menu screen, click "Exit", shutdown information will appear (see Figure 3-5).

Figure 3-5

If turn off the instrument, click "Yes" After finishing maintenance, cleaning and
shutdown procedures, "Thank you, and now turn off power" will appear to instruct
operator to turn off the power switch on rear panel.

2) Tidy the work platform and dispose waste.

3) Click "No" if operator does not want to shutdown analyzer temporarily.

NOTE: Wrong operations on shutdown procedure will decrease reliability and

performance of the analyzer, any problems derived from that will NOT be guaranteed
free.

CAUTION: May lead to data loses if turn off the analyzer against procedures.

3.19 Data Query 

The information, parameters and histograms of test results can be reviewed and printed
out by recorder or printer.
At main menu screen, click "Rev" to enter query screen as shown in Figure 3-6.
Click "Condi" at query screen, then condition query screen will appear as shown in Figure 3-
7. Operator can query the results according to Date, Name, Barcode, Dept, Sender and
Checker. In Figure 3-7, enter the time interval, click "OK", and then the samples in this time
interval will be shown in the query list. As shown in Figure 3-8.
  
  Page 41
 

Figure 3-6 Query

Figure 3-7 Condition Query

  
  Page 42
 

3.19.1 Selection, Browse, Modification and Output of Data 

At main menu screen, click "Func", and then click "Rev" to enter query screen.
Data of today will be displayed in the list box as Figure 3-6.
Select data in the list, and then click "Detail", that the analyzer enters into detail
inquiry window.
Condi: Query data that are compliant with specific criteria in certain period.
Detail: Select a data in the list, click "Detail", the parameters result and
histograms of selected data will be displayed.
Pgprv/Pgnex: If the data is too much to display in one page, the system will display the
data in more pages. Click "Pgpre" or "Pgnex" to view more information.

Print: Click "Print" to print the selected data.

P_All: Click "P_ All" to print all the data in current list by printer.
Count: Click "Count" to print all the data saved in list by printer according to counterfoil
format.
Back: Click “Back” to go back to main menu screen
  
  Page 43
 
3.19.2 Data Deletion 
 

If the sample quantity reaches a certain amount and take up a large save space, operator
can delete the data termly if necessary. Data deletion is divided into “Delete” and “Delete
All”.

1) Delete All

Click “DelAll”, a dialog box as Figure 3-9 will present, input password 9999, then the system
will prompt to ask whether you want to delete all, see Figure 3-10, if click “Yes”, then system
will perform all delete operations to current page.

Figure 3-9 Password

Figure 3-10 Delete All Query Dialog Box

2) Delete Single

In the interface as shown in Figure 3-8, select the data and then click “Del”, the dialog box as
Figure 3-11 will display.

Figure 3-11 Delete Query Dialog Box

Select Yes to delete the data. Select No to cancel the deletion.

  
  Page 44
 
NOTE: Be aware that the data once being deleted, it can NOT be recovered, please operate
with caution.

3.19.3 Workload Statistics 

At main menu screen, click "Func"~ "Stast" to enter Workload statistics window. See Figure
3-12. Operation procedure is as follows:

Figure 3-12 Workload Statistics

1) At “From” and “To”, select starting date and ending date in pop-up calendar, then press
“OK”.

2) Select one statistic type on left side of the Workload Statistics screen and then all items
will be displayed in the middle box.

3) Select item needed (multi-select is allowed), click “Stast”, and then the desired data will
be displayed in the list on right.

4) Click “Back” to return to main menu screen.

5) Choose one sender, and click “Print”, then all items will be print.
  
  Page 45
 
3.20 Special Function 
 

3.20.1 Precision Counting 
 

At Query screen, operator may check the sample precision.

3.20.1.1 Select Sample Results 

Aer data review from condition Que click one result, then press space bar (click "Seect"
if using touch screen), the result will be selected and in rd letters as Figure 3-13.

3.20.1.2 Check Precision 
After selecting one sample result as preceding method, press F9 (click „CV” if using touch
screen) to enter the CV data screen like as Figure 3-14.

„Mean” indicates the parameter average value of selected samples. „CV” indicates the
Coefficient of Variance of corresponding parameter.

NOTE: The system can only calculate CV automatically when more then one sample results
are selected.
  
  Page 46
 
NOTE: If only one sample result is selected, the „Mean” indicates the sample result itself.

Figure 3-14 CV Count

3.20.2 Trend Graph 
 

At Query screen, operator may review the sample trend graph.

First, select one sample result.

After data review from condition query, click one result, and press space bar (click „Select” if
using touch screen), the result will be selected to be in red letters like Figure 3-15.
  
  Page 47
 

Figure 3-15 Select samples

Second, review the trend graph.

After selecting one sample result as preceding method, press F8 *click „Trans” if using touch
screen) to enter the trend screen like Figure 3-16.
  
  Page 48
 

Figure 3-16 Trend Graph

Param.: Click „Param” to review another parameter trend graph;

Left: Click „Left”, then the chart pole will shift one grid to the left. See Figure 3-17.

Right: Click „Right”, then the chart pole will shift one grid to the right. See Figure 3-18.
  
  Page 49
 

Figure 3-17 Left Shift Chart Pole

Figure 3-18 Right Shift Chart Pole

Back: Click „Back” to return to Query screen.

  
  Page 50
 
CHAPTER 4 Soft Keyboard 
 

The automated hematology analyzer adopt t-touch interactive mode. Systems provide soft
keyboard input mode to facilate the data input and other input operations. Soft keyboard is
as Figure 4-1 shown.

Figure 4-1 Keyboard

The default soft keyboard is in English lowercase mode, click „CAP” key to switch to English
uppercase mode, as shown in Figure 4-2.

Figure 4-2 Uppercase Mode

4.1 Soft Keyboard Introduction 
 

1. Layout

Ther are 43 keys in soft keyboard: 10 number keys, 26 alphabet keys, backspace key, slash
key, space key, CAP key.

„Å”: Backspace key, delete the character before cursor;

„.”: Slash key, enter a slash;

„Spc”: Space key, enter a space;

„CAP”: Switch between lowercase and uppercase;

  
  Page 51
 
2. Character Input

First click the target edit box, at this time the top of the target of the target interface is blue,
then click soft keyboard, right now the top of the soft keyboard changes from gray to blue.
User can switch between uppercase and lowercase by clickin „CAP” and then click the
keyboard input.

3. Delete Character

First move the cursor behind the character that needs to be deleted, click „Å” to delete the
character before the cursor.

4.2 Function 
 

The soft keyboard is displayed in the following screens: data edit, condition query,
parameters limit setting, control edit, system calibration, system setting and service.

4.2.1 Data Edit 
The procedure of inputting information in edit box is as follows:

1) Click target edit box, move the cursor on the edit box;

2) Click the soft keyboard, then user can input data through soft keyboard;

3) After data input, click data edit screen to move the cursor to it. Click „OK” to save the
operations, click „No” to cancel and exit the data edit screen. See Figure 4-3.
  
  Page 52
 

Figure 4-3 Data Edit

4.2.2 Condition Query 
 

Click „Condi” at query screen, condition query and soft keyboard will pop up at the same
time, and soft keyboard is warded off by condition query screen.

The procedure of inputting information in edit box is as follows:

1) Click target edit box, move the cursor on the edit box;

2) Click the soft keyboard, this moment soft keyboard is warded off by condition query
screen, click soft keyboard to input data;

3) After data input, click condition query screen to move the cursor on this screen, click „OK”
to query according to input conditions, click „No” to cancel and exit query. See Figure 4-4.
  
  Page 53
 

Figure 4-4 Condition Query

4.2.3 parameter Limit setting 
 

Enter the parameter setting screen, click „Keyboard”, soft keyboard will pop up, if click
„Keyboard” again, soft keyboard will be hidden.

The procedure of inputting information in edit box is as follows:

1) Click target edit box, move the cursor on the edtit box;

2) Click soft keyboard, user can input data through soft keyboard;

3) After data input, click parameter limit setting screen to move the cursor on this screen.
This moment soft keyboard will be hidden. If click „Keyboard” again, the soft keyboard will
pop up;

4) When the focus is on parameter limit setting screen, click „OK” to save, click „Back” to
cancel and exit. See Figure 4-5.
  
  Page 54
 

 
Figure 4-5 Parameter Limit Setting

4.2.4 L­J QC Edit 

Enter L.-J QC Edit screen, click "Keyboard", then soft keyboard will pop up, if
click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:

1) Click target edit box first, move the cursor on the edit box;
2) Click soft keyboard, user can input data through soft keyboard;

3) After data input, click L-J QC edit screen to move the cursor on this screen.
This moment soft keyboard will be hidden. If click "Keyboard" again, the
soft keyboard will pop up;
4) When the focus is on L-J QC edit screen, click "OK" to save, click "Back" to
cancel and exit. See Figure 4-6.
  
  Page 55
 

Figure 4-6 L-J QC Edit

4.2.5 X­B QC Edit 
 

Enter X-B QC Edit screen, click „Keyboard”, then soft keyboard will pop up. If click
„Keyboard” again, soft keyboard will be hidden.

The procedure of inputting information in edit box is as follow:

1) Click target edit box first, move the cursor on edit box;

2) Click soft keyboard, then user can input data through soft keyboard;

3) After data input, click X-B QC edit screen to move the cursor on this screen, this moment
the soft keyboard will be hidden. If click „Keyboard”again, the soft keyboard will pop up;

4) When the focus is on X-B QC edit screen, click „OK” to save, click „Back” to cancel and
exit. See Figure 4-7.
  
  Page 56
 

 
Figure 4-7 X-B QC Edit

 
4.2.6 X QC Edit 

Enter X QC Edit screen, click "Keyboard", then the soft keyboard will pop up, if
click "Keyboard" aglain, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box first, move the cursor on the edit box;
2) Click soft keyboard, then user can input data through soft keyboard;

3) After data input, click X QC edit screen to move the cursor on this screen,
this moment soft keyboard will be hidden. If click "Keyboard" again, the
soft keyboard will pop up;
4) When the focus is on X QC edit screen, click "OK" to save, click "Back" to
cancel and exit. See Figure 4-8.
  
  Page 57
 

Figure 4-8 X QC Edit

4.2.7 Manual Calibration 
 

Enter manual calibration screen, click „Keyboard”, then soft keyboard will pop up, if click
„Keyboard”again, soft keyboard will be hidden.

1) Click target edit box, move the cursor on the edit box;

2) Click soft keyboard, then user can input data through soft keyboardl

3) After data input, click manual calibration screen to move the cursor on this screen, this
moment soft keyboard will be hidden. If click „Keyboard” again, soft keyboard will pop up;

4) When the focus is on manual calibration screen, click „OK” to save, click „Back” to cancel
and exit. See Figure 4-9.
  
  Page 58
 

Figure 4-9 Manual Calibration

4.2.8 Automatic Calibration 

Enter automatic calibration screen, click "Keyboard", soft keyboard will pop up.
If click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box, move the cursor on the edit box;
2) Click soft keyboard, then user can input data through soft keyboard;

3) After data input, click automatic calibration screen to move the cursor on
this screen, this moment soft keyboard will be hidden. If click "Keyboard"
again, soft keyboard will pop up;
4) When the focus is on automatic calibration screen, click "OK" to save, click
"Back" to cancel and exit. See Figure 4-10.
  
  Page 59
 

Figure 4-10 Automatic Calibration

4.2.9 System Setting 

Enter system setting screen, click "Keyboard", soft keyboard will pop up.
If click "Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
5) Click target edit box, move the cursor on the edit box;
6) Click soft keyboard, then user can input jets through soft keyboard;

7) After data input, click system setting on screen to move the cursor on
this screen, this moment soft keyboard will be hidden. If click "Keyboard"
again, soft keyboard will pop up;
8) When the focus is on system settin screen, click "OK" to save, click
"Back" to cancel and exit. See Figure 4-11.
  
  Page 60
 

Figure 4-11 System Setting

4.2.10 Service 

Enter service screen, click "Keyboard", then soft keyboard will pop up, if click
"Keyboard" again, soft keyboard will be hidden.
The procedure of inputting information in edit box is as follows:
1) Click target edit box, move the cursor on edit box;
2) Click soft keyboard, then user can input data through soft keyboard.

3) After data input, click service screen to move the cursor on this screen, this
moment the soft keyboard will be hidden. If click "Keyboard" again, the soft
keyboard will pop up.
4) When the focus is on service screen, click "OK" to save, click "Back" to
cancel and exit. See Figure 4-12.
  
  Page 61
 

Figure 4-12 Service

  
  Page 62
 
CHAPTER 5 System Setting 

This machine has 4 options to satisfy different requirements of laboratory and clinical
diagnostics. Operator can choose different operating modes according to actual need.
At main menu screen, click "Func" And then click "Setup". The Setup menu will be displayed
as Figure 5-1:

Figure 5-1 System Setting

5.1 System Maintenance 

Warning: Alarm the errors in analyzer.

Auto clean: The analyzer will rinse automatically for each set interval.
Auto blank: Select ON in Auto-Blank and click "OK", the analyzer will run a background
test automatically when startup the analyzer each time.
Auto sleep: The analyzer will enter dormancy status if there is no operation for a period of
time
  
  Page 63
 
Pre-diluent notice: If Pre-diluent is ON, each time when operator runs a sample, the system
will prompt that whether or not to run the sample under pre-diluent mode.

5.2 Transfer Setting 
 

In transfer setting as Figure 5-2, operator can setup the port number, boud rate, data bit,
stop bit and parity bit of the communication port. The communication parameters are set
before delivery. User should not modify them; otherwise the data can not be transmitted.

Auto trans: the test result will be transmitted from the communication port automatically.

Encoded: hexadecimal and ASCII.

NOTE: Transfer setting should be under the guidance of the engineer.

Figure 5-2 Transfer Setting

  
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5.3 Print Setting 

In Print Setting as Figure 5-3, operator can select printer type, print format, auto print, and
input hospital name in „print title”.

Figure 5-3 Print Setting

  
  Page 65
 
5.4 Parameter Setting 

In Parameter Setting as Figure 5-4, operator can setup the unit of WBC, RBC, PLT, HGB
and MCHC, as well as the language and other parameters.

Figure 5-4 Reference Value Setting

  
  Page 66
 
5.5 Date/Time Setting 

In Date/Time Setting as Figure 5-5, there are 3 formats of date: YYYY-MM-DD, MM-DD-
YYYY, and DD-MM-YYYY. Y indicates Year, M indicates Month, D indicates Day. The
selected date format will be displayed.
The resetting of the data format will affect the display format of data on blood cell analysis
screen.

Figure 5-5 Time Setting

  
  Page 67
 
5.6 System Version 
 

User can check the software version, printer software version printer template version,
FPGA version, kernel version and library version. If there are problems, the user can provide
this information to the service engineers as Figure 5-6.

Figure 5-6 System Version

NOTE: Above system setting have been set up before delivery. User does not need to reset
them generally. If needed, all the operations should be under guidance of the engineer.
  
  Page 68
 
CHAPTER 6 Quality Control 

Quality control is needed for maintaining the analyzer precision and eliminating system
errors. The automated hematology analyzer offers four quality control options: L-J QC,
QC, -R QC and X.-B QC. In following conditions, perform quality control with control
materials recommended by us.
o After daily start-up procedures completed
o The reagent lot number changed
o After calibration
o After maintenance, or component replacement
o In accordance with the laboratory or clinical QC protocol

To ensure the accuracy of result, commercial controls must be handled follows:

o Make sure the controls stored at low temperature and without leakage.
o Mix the controls according to the manufacturer's recommendations.
o Never use controls which are unsealed longer than the period recommended by
manufacturer.
o Never subject controls to extreme heat or vibration.
o Perform the high, normal and low controls of new lot, and compare the values with last
lot to verify the difference.

CAUTION: Consider all clinical specimens, controls and calibrators 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.

6.1 Quality Control Options 

(1) L-J QC

L.-J QC (Levey-Jennings graph) is a simple and visual QC method. Operator can draw QC
value directly on graph after getting the Mean, SD and CV which derived from following
formulas:
  
  Page 69
 

(2) X-R QC

In X-R QC method, indicates mean value, R indicates range of value. 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
QC is the variation of -R QC; they have the same basic principle. The difference is that the
control dot in graph indicates the mean value of two values other than a single value. On
this foundation, analyzer calculates the
Mean, SD and CV.

(4) X-B QC

X-B QC is a moving average method promoted in 1970s. Its 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, X-B QC is done by detecting the value of MCV,
MCH, and MCHC.

6.2 QC Operation 
 

6.2.1 QC Mode Select 

In main menu screen, click “Func” and then select “QC”, dialog box as Figure 6-1 will pop
up.
  
  Page 70
 

Figure 6-1 QC Mode select

The automated hematology analyzer offers 4 quality control options: L-.J QC, X-B QC, -x -R
QC and QC. Select QC mode and click ":OK" to enter corresponding QC interface.

6.2.2 L­J QC 

Select L-J QC mode and click "OK" to enter corresponding screen as Figure 6-2.

Figure 6-2 L-J QC

  
  Page 71
 
6.2.2.1 L­J QC Edit 

In L-J QC screen click “Edit”, enter QC Edit screen as figure 6-3. There are 3 different
groups and each group has 3 (low, normal and high) levels. Input control lot No., expiry date,
assay and limit according to the control description.

NOTE: Assay is a standard value which is the reference of quality control. Limit indicates the
allowable biased range, but the limit should not be more than 40% of assay, or it cannot be
saved in database.
NOTE: The expiry date format should be MM-DD-YYYY.

Figure 6-3 L-J QC Edit

  
  Page 72
 
6.2.2.2 L­J QC Run 

In L-J QC screen click "Run", enter QC Run screen as Figure 6-4.

At QC Run screen, place the control tube under aspiration probe, press RUN key, the
analyzer will start to process control sample. L-J QC needs control material. If run a
background QC, the system will alarm QC result is invalid. Each time runs the L-J QC, "Run
Time" on upper right corner of the Run screen will be updated correspondingly. Lot No. and
expiry date can be input in Edit screen.

Figure 6-4 L-J QC Run

  
  Page 73
 
6.2.2.3 LJ QC Review 

The automated hematology analyzer offers 2 ways to review: QC Graph and QC Data.

(1) L-.J QC Graph

Click "Back" in QC Run screen or select corresponding QC mode in QC Mode

dialog box, enter the L-.J QC screen to review 12 parameters of QC results. See Figure 6-.5.

Figure 6- S LJ QC Graph

In L.-J QC screen, there are low, normal and high graphs. If select group 1 and
low level to run QC, the control dot will present in low 1 graph. It is also true for
other types of QC.

There are function buttons at the bottom of L-.J QC screen. Click "Group" to
change the group. Click "Paramr to change current displayed parameter, for
instance, change from WBC to RBC. Click "Level" to shift the classification line
in the same group. Click "Left" or "Right" to shift the classification line in same
  
  Page 74
 
QC graph. Click "Print" to print the current data.

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 times, ordinate indicates QC results.
2.QC graph can display 31 dots for each parameter.
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 each parameter's graph mean:
o upper limit -- assay plus limit
o middle line -- assay
o lower limit -- assay subtract limit

If the control dot falls in the area between upper and lower lines of the
corresponding graph, it means the dot is in the control range; if not, the dot is
not in the control range. .

(2) L-J QC Data

In L-J QC graph screen (see Figure 6-5), click "Data", operator can review QC
data with 12 parameters as Figure 6-6 shows.

 
Figure 6-6 L-J QC Data
  
  Page 75
 
In this screen, click “Group” to change group, click “Left” or “Right” to switch page. Operator
could review 31 items at most. Click “Del All” to delete all data. The assay and limit can be
input and changed in QC Edit screen.
The QC data would be updated after running a new control.

6.2.3 X QC 
 

6.2.3.1 X QC Edit 
 

Select X QC mode in the dialog box as Figure 6-1 shows and then click “OK” to enter
corresponding screen. Click “Edit”, enter X QC Edit screen as Figure 6-7.

Figure 6-7 X QC Edit

In X QC Editscreen, click |Group” to switch group; click “Del” to delete current assay and
limit; click “OK” to save the current assay and limit; click “Back” to exit X QC Edit screen.

NOTE: The same as L-J QC, the limit should not be more than 40% of assay or it cannot be
saved in database.
  
  Page 76
 
NOTE: The expiry date format should be MM-DD-YYYY

6.2.3.2 X QC Run 

In X QC screen click "Run", enter QC Run screen as Figure 6-4.

At this screen, system displays two control results and calculate the mean value
automatically. The assay is input in X QC Edit screen. Click “Group” to swith group; click
“Back” to exit.

Figure 6-8 X QC Run

In X QC Run screen, place the control tube under aspiration probe, press RUN key, the
analyzer will start to process control sample. If the current group assay is empty, the system
will display “No QC reference data, cannot perform QC running”. At this time , operator
should back to the Edit screen to input assay and limit.
X QC needs control material. If run a background QC, the system will alarm QC result is
invalid.
  
  Page 77
 
6.2.3.3  QC Review 
The automated hematology analyzer offers 2 ways to review: QC Graph and
QC Data.

(1) X QC Graph

Click "Back" in QC Run screen or select corresponding QC mode in QC Mode

dialog box, enter the x QC screen as Figure 6-9 shows. Operator can review
12 parameters of QC results. As a difference to L-J QC Graph, the dot on
QC Graph indicates the mean value of 2 QC results.

Figure 6-9 X QC Graph

In QC screen, there are low, normal and high graphs. If select group 1 and low level to run
QC, the control dot will present in low 1 graph. It is also true for other types of QC.
There are function buttons at the bottom of QC screen. Click "Group" to change the group.
Click "Param" to change current displayed parameter, for instance, change from WBC to
RBC. Click "Level" to shift the classification line in the same group. Click "Left" or "Right" to
shift the classification line in same QC graph. Click "Print" to print the current data.

QC results are arranged in graphs according to storage time. The latest is on the left side
  
  Page 78
 
and its serial number is 1.
QC graph instruction:
1.Graph abscissa indicates QC run times, ordinate indicates QC results.
2. QC graph can display 31 dots for each parameter.
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:

o upper limit -- assay plus limit
o middle line -- assay
o lower limit -- assay subtract limit
If the control dot falls in the area between upper and lower lines of the
corresponding graph, it means the dot is in the control range; if not, it is not in
the control range.
(2) QC Data

In L-,J QC graph screen (see Figure 6-9), click "Data", operator can review QC data with 12
parameters as Figure 6-10 shows.

In this screen, click “Group” to change group, click “Left” or “Right” to switch page. Operator
could review 31 items at most. Click “Del All” to delete all data. The assay and limit can be
input and changed in QC Edit screen.
The QC data would be updated after running QC twice. At the same time, the mean value
will be displayed..
  
  Page 79
 

Figure 6-10 X QC Data

6.2.4 X­R QC 
 

6.2.4.1 X­R QC Run 
 

On X-R QC screen click “Run”, enter QC Run screen as figure 6-11.

At this screen, system display two control result and calculate the mean value and range
automatically. Click “Group” to switch group, click “Back”to exit.

X-R QC needs material. If run a background QC, the system will alarm QC result is invalid.
  
  Page 80
 

Figure 6-11 X-R QC Run

6.2.4.2 X ­R QC Review 
The automated hematology analyzer offers two ways to review: QC Graph and QC Data.
(1) X -R QC Graph

Click "Back" on QC Run screen or select corresponding QC mode in QC Mode dialog box,
enter the X-R QC screen as Figure 6-12 shows. Operator can review QC results with 12
parameters. The dot on X-R QC Graph indicates mean value or range of 2 QC results. The
system cannot display low, normal and high control graphs simultaneously in one screen,
please click "Group" to switch.

X-R QC graph is divided into 2 parts: X graph and R graph. X graph displays mean value
dots while the R graph displays range dots.
There are function buttons at the bottom of X-R QC screen. Click "Group" to change the
group. Click "Param" to change current displayed parameter, for instance, change from
WBC to RBC. Click "Level" to shift the classification line between and R graphs. Click "Left"
or "Right" to shift the classification line in X or R graph. Click “Print” to print current data.
  
  Page 81
 

Figure 6-12 X-R QC Graph

QC results are arranged in graphs according to storage time. The latest is on the left side
and its serial number is 1.

X QC graph instruction:
1. Graph abscissa indicates QC run times, ordinate indicates QC results.
2. QC graph can display 31 dots for each parameter.
3. Every parameter graph's middle transverse line indicates X – the mean value of QC
results.
4. Every parameter graph's upper transverse line means X upper limit = X+AxR
5. Every parameter graph's lower transverse line means X lower limit = X-AxR

6. The 3 values on the left side of parameter graph mean:

o upper limit – X upper limit=X+AxR
o middle line -- X
o lower limit – X lower limit=X-AxR
  
  Page 82
 
R graph instruction:
1.Graph abscissa indicates QC run times, ordinate indicates QC result.
2.QC graph can display 31 dots for each parameter.

3. Every parameter graph's middle transverse line indicates R-the mean value of
QC result range.
4. Every parameter graph's upper transverse line means R upper limit=BxR.
5. Every parameter graph's lower transverse line means R lower limit=CxR.
6. The 3 values on the left side of parameter graph mean:
o upper limit -- R upper limit= BxR
o middle line -- R
o lower limit -- R lower limit- CxR

If the control dot falls in the area between upper and lower lines of the
corresponding graph, it means the dot is in the control range; if not, the dot is
not in the control range.

(2) X-R QC Data

In X-R QC Graph screen (See Figure 6-12), click "Data", operator can review QC data
with 12 parameters as Figure 6-13 shows.
On this screen, click "Group" to change group, click "Left" or "Right" to switch page.
Operator could review 31 items at most. Click "DelAlI" to delete all the data.
X-R QC data screen a only display three control results, and each one contains mean
and range. The first two lists on this screen are total mean and average range. See
Figure 6-13.
The QC data would be p ated after running new controls twice.
  
  Page 83
 

Figure 6-13 X-R QC Data

6.2.5 X­B QC 
 

6.2.5.1 X­B QC Edit 
 

X-B QC Edit is different to others, with which the system edits only three parameters: MCV,
MCH and MCHC.

Select X-B QC mode in the dialog box as Figure 6-14 shows and then click “OK” to enter the
X-B QC screen, then click “Edit” to enter X-B QC Edit screen. See figure 6-14.

At Edit screen, click “Del” to delete current assay and limit; click “OK| to save them; click
“Back” to exit.
NOTE: Assay is a standard value which is the reference of quality control. Limit indicate the
allowable biased range, but limit should not be ore then 40% of assay or it cannot be saved
in database.
NOTE: The expiry date format should be MM-DD-YYYY.
  
  Page 84
 

Figure 6-14 X-B QC Edit

6.2.5.2 X­B QC Run 

X.-B QC is a moving average method, which needs no control material.

Click "Run" on the X-B QC screen to enter the X-.B QC Run screen as Figure 6-15. "X-BQC
Run" is for selecting to run X-.B QC or not. "Sample num" is for selecting the quantity of
samples for each group. For example, if "X-BQC Run" is ON and "Sample num" is 20, the
subsequent 20 counts will be X-B QC.
Click "OK" to save the current selections.
After 20 times of count completed, back to the Run screen and click "COUNT", system will
calculate the QC results and display them in QC Graph and QC Data.
  
  Page 85
 

Figure 6-15 X-B QC Run

6.2.5.3 X­B QC Review

The automated hematology analyzer offer two ways to review QC result: QC graph and QC
data.

(1) X-B QC Graph

Click “Back| on QC Run screen or select corresponding QC mode in QC Mode dialog box to
enter the X-B QC screen as Figure 6-16. Operator can review QC results with 3 parameters.
After the count of group samples completed, the results of MCV, MCH, MCHC will be
depicted as dots on the graph. For example, the “X-BQC Run” is oN and “Sample num” is
20, then after 20 counts, the system will calculate a X-B QC value and display a
corresponding control dot on the graph.
X-B QC Screen can display graphs of MCV, MCV and MCHC. And the gaph will be updated
after each QC counting.
The function buttons are basically as the same as other QCs with additional “Pgpre” and
“Pgnex” QC results are arranged in grphs according to storage time. The latest is on the left
side and its serial number is 1.
  
  Page 86
 
X-B QC Graph instruction:
1.Graph abscissa indicates QC run times, ordinate indicates QC results.
2.QC graph can display 31 dots for each parameter..
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:
o upper limit -- assay plus limit
o middle line -- assay
o lower limit -- assay subtract 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, it is not under control range. See
Figure 6-16.

 
Figure 6-16 X-B QC Graph

(2) X-B QC Data

In the screen as Figure 6-16, click "Data", operator can review 3 parameters
QC data as Figure 6-17 shows. Click "Left" or "Right" to switch page, operator
could review 31 items at most. Click "DelAII" to delete all the data. The Assay
  
  Page 87
 
And Limit can be input and changed in QC Edit screen.
The QC data would be updated after running a new control.

Figure 6-17 X-B QC Data

  
  Page 88
 
CHAPTER 7 Calibration 

To ensure analyzer s precision and obtain reliable test results, the parameters (WBC, RBC
PLT, HGB, and MCV) should be calibrated in the following situations:

1)Working environment changes greatly.

2)One or multiple parameters' test results are moving.

3) Any major component that could affect the measurement is replaced.

4)Requirement of clinic or laboratory.

5)The reagent has been replaced.

6)The analyzer presents deviation when running quality control.

MCV, HCT are relative parameters to each other, thus one can be obtained from given value
of the other. Only MCV will be calibrated by the analyzer. Usually the manufacturer artificial
blood material will give reference value for MCV, HCT at the same time.

CAUTION: Consider all clinical specimens, control and calibrators etc. that contain human
blood or serum as potentially infectious. Wear lab coat, gloves and safety grasses and follow
required laboratorial or clinical procedure when handling thes materials.
CAUTION: Only calibrators recommended by NeoMedica can be used to accomplish the
calibration.
CAUTION: Follow the recommendations provided by manufacturer to store the calibrators
CAUTION: Check if the container is broken or cracked before using the calibrator.
CAUTION: Make sure the calibrators are whitin expiry date.
CAUTION: Make sure the analyzator has no problem before calibration.
CAUTION: Never apply test data to laboratory or clinic use unless all parameters are
accurately calibrated.
  
  Page 89
 
7.1 Preparation for Calibration 
 

Before calibration, inspect analyzer as follow:

1) Ensure the adequate reagents are in shelf life and uncontaminated.

2) Run a background test and make sure the results are qualified.

3) The analyzer is fault-free.

4) Verify the precision of the analyzer. At main menu screen, run normal control 11 times,
query the results from second to eleventh in Query screen, make sure the CVs are within the
prescribed limit in Table 7-1.

Table 7-1 Precision

Parameter Acceptable Limits Precision Range

(CV %)
WBC ≤2.0 % 4.0x109/L – 15.0x109/L
RBC ≤1.5% 3.00x1012/L -6.00x1012/L
HGB ≤1.5% 100g/L - 180g/L
HCT ≤2.0% 35% - 50%
MCV ≤1.0% 76fL – 110fL
PLT ≤5.0% 100x109/L – 500x109/L

5) Running with high control in triplicate, then using diluents instead of high control to test 3
times continuously, Carryover(%) is calculated from the folloing formula. Results must
conform to Table 7-2.

Table 7-2 Carryover

Parameter Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
PLT ≤0.5%
  
  Page 90
 
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 Manual Calibration

At main menu screen, click "Cal" to enter System Calibration screen. Choose "manual Cal",
click "OK" to enter manual calibration interface.
Input assay and values, then click "New Cal" button, the system will calculate the new
calibrated value automatically and the date will be updated simultaneously. See Figure 7-1:

Figure 7-1 Manual Calibration

Click "OK" to save the new calibration values.

Click "Print" to print the new calibration values.
Click "Back" to exit the System Cal.
  
  Page 91
 
Counting principle of new calibration value:
o New calibration value=(assay/mean value) xformer calibration value
o If the new calibration value<70%, consider it equals to 70%; if the new
calibration value>130%, consider it equals to 130%.

NOTE: Calibration coefficient is allowed in the range of 70%~130%, if the test value exceed
the limit, this critical value will be selected as the new coefficient for calibration.
NOTE: Analyzer can calibrate a certain parameter or all parameters of WBC, RBC,
HGB, MCV, MPV, RDW_CV, RDW_SD, PLT and PDW.
CAUTION: Data will be lost if exit without pressing "OK" to save.

7.3 Auto Calibration 

At main menu screen, click "Cal" to enter System Calibration screen, Choose "Auto Cal',
click "OK" to enter auto calibration interface. See Figure 7-2.

 
Figure 7-2 Automatic Calibration
  
  Page 92
 
At Auto Calibration Mode, input assay then place the calibrator tube under the aspiration
probe, press RUN key, the analyzer starts to count and then displays the results in Value 1
to Value 4 according to the sequence of 4 counts.
Analyzer cannot count or display the test value in following conditions:

1) After counting for 5 times, press RUN key, analyzer will prompt that there is no space to
process calibration count.
2) If the precision of test result is abnormal, analyzer will prompt "data is abnormal, please
re-counting"
3) After each counting, analyzer will calculate a new calibration value according to
reference value and test result and update the calibration date.
Click "Print" to print the new calibration values.

Counting principle of new calibration value:

• Mean of the new calibration value:

• New calibration value=(assay/mean value) xformer calibration value

• If the new calibration value<70%, consider it equals to 70%; if the new
calibration value>130%, consider it equals to 130%.
NOTE: Click "OK" after counting and then system will save the values. Click "Back"
without clicking "OK", the value will not be saved.
  
  Page 93
 
CHAPTER 8 Parameter Limit 

To monitor abnormal blood sample measurement, it is essential for the operator to setup
normal ranges of the parameter according to laboratorial or clinical requirement. Prompt or
indication will be given if the test values exceed the range. The limits of 21 parameters are
discussed in this chapter, any results exceeding the range will be marked with 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.

8.1 Limit Review 

At Limit Setting screen, operator can input proper parameter limits or use default limits.
Default limits are different depending on patient group. Figure 8-1 depicts General group
limits. Figure 8-2 depicts User 1 group limits

Figure 8-1 General Group

  
  Page 94
 

Figure 8-2 User 1 Group

Click "Def”, the system prompts the operator to decide whether to recover all the default
limits. Select "Yes" to recover parameters of all groups to default limits; select "No" to exit.
See Figure 8.-3.

Figure 8-3 Recover to Default Limit

Click "OK" to save current default limits which will be displayed when operator enter Limit
Setting screen again.
  
  Page 95
 
8.2 Limit Modification 

Operate as follows to modify the parameter limit:

1) At main menu screen, click “Func”, then click “Limits” to enter limit setting screen

2) Click “Group”, the screen displays the lower and upper limits of parameters in current
group.

3) Select the lower or upper limit of the parameter that operator wanted to modify,
delete the former limit by Backspace key on keyboard, then input the new lower or upper
limit.

4) Click “OK”, and then the dialog box as Figure 8-4 shows will pop up, select “Yes” or
“No” to save the modification or not.

Figure 8-4 Save the New Setup

8.3 Print 
 

Click “Print”, then system will print out limits of all groups in list form automatically.
  
  Page 96
 
CHAPTER 9 Maintenance 

Routine care and regular maintenance are essential to keep optimal performance, minimize
system problems and prolong the life span. Procedures and instructions of preventive
maintenance are discussed in this chapter. More information is available at the Customer
Support Centre.
Preventive maintenance should be performed periodically. Pertinent maintenance is also
included in this Chapter according to actual requirement.

WARNING: A normative maintenance criterion should be performed strictly to avoid

analyzer failure.
WARNING: Perform individual protection before instrument maintenance, such as wear
glove, respirator and lab coat etc.

9.1 Daily Maintenance 

The automated hematology analyzer is designed with daily auto-maintenance program. As

shown in Figure 9-1, operator can select the auto-clean time to maintain the system. Please
refer to Table 9-1 for time setting.
  
  Page 97
 

Figure 9-1 System Maintenance Setting

Table 9-1 Time Setting

9.2 Weekly Maintenance 

9.2.1 Surface Maintenance 

Clean the smudge on the surface of analyzer, especially the spilled blood on the aspiration
probe and surrounding, to remove the protein buildup or debris and reduce the possibility of
a blockage. Wipe the outside of the probe and surrounding with gauze soaked by litmusless
  
  Page 98
 
detergent before cleaning other parts.
CAUTION: Never use corrosive acids, alkali or volatile organic solvent (such as acetone,
aether and chloroforms etc.) to clean the outside of the analyzer. Only litmusless detergent
is allowed.

9.3 Monthly Maintenance 

Monthly maintenance mainly aims at mechanism maintenance, including lubricant motor

shaft, X, Y leaders of sampling organ etc..

NOTE: Ensure the power of host is off before monthly maintenance

9.4 System Maintenance 

At main menu screen select "Func", then select "Maint" to enter the screen as
Figure 9-2.

Figure 9-2 System Maintenance

  
  Page 99
 
The automated hematology analyzer offers 10 maintenance functions as follows:
• Cauterize Aperture
• Flush Aperture
• Drain Cups
• Rinse Cups
• Prime Lyse
• Prime Diluent
• Prime Detergent
• Prime Fluidics
• Prepare Shipping

9.4.1 Cauterize Aperture 

Cauterize Aperture helps to prevent and remove aperture clog. Procedure is as follows:
1. Select "Cauterize Aperture" at Maintain screen.

2. The analyzer starts to perform the function and display the progress bar at the
bottom of the screen.
3. After completing, system will back to the Maintain screen.

9.4.2 Flush Aperture 

Flush Aperture helps to prevent and remove aperture clog associating with Cauterize
Aperture. The procedure is as follows:
1 Select "Flush Aperture" in Maintain screen.

2. The analyzer starts to perform the function and display the progress bar at the
bottom of the screen.
3. After completing, system will back to the Maintain screen.

9.4.3 Drain Cups 

Perform this operation to drain diluent out of WBC and RBC cups.
  
  Page 100
 
9.4.4 Rinse Cups 

Perform this operation to rinse the aperture to prevent blockage when counting time is too
long. The procedure is as follows:

1. Select "Rinse Cups" in Maintain screen.

2. The analyzer starts to perform the function and display the progress
bar at the bottom of the screen.
3. After completing, system will back to the Maintain screen.

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.
  
  Page 101
 
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.

  
  Page 102
 
9.5 Maintenance before Shipping 

If the analyzer is left unused for more than 3 months or being shipped, please perform
following operations for maintenance:
1) Take out the diluent inlet tube which is connecting with diluent port on the rear panel
from waste container, discharge the remaining diluient in tube.
2) Take out the lyse inlet tube which is connecting with lyse port on the rear panel from
waste container, discharge the remaining lyse in tube.
3) Take out the detergent inlet tube which is connecting with detergent port on the rear
panel from waste container, discharge the remaining detergent in tube.
4) Store the remaining reagents according to instructions and avoid supercooling and
overheating. Operator should establish and conform to effective storage measures to
prevent reagent from degeneration, misusage or misdrinking.
5) Keep the diluent, lyse and detergent inlet tubes hanging in the air. At main menu
screen, click "Prime" several times until the top left corner of the screen present "No
Diluent", "No Lyse", "No Detergent", then Click "Prime" once again.
6) Insert diluent, lyse and detergent tubes into distilled water. At main menu screen, click
"Func"Æ"Maint"Æ"Prepare Shipping" to inter the screen as Figure 9 6 shows.
  
  Page 103
 

Figure 9-8 Select Prepare Shipping

1) After completed, take out the diluent, lyse and detergent tubes from distilled
water and click "Prepare Shipping" again to drain the reagent in tubes.
2) At main menu screen, click "Exit", "Thank you, now turn off power" will appear to
instruct the operator to turn off the power switch on the rear panel.
3) Pull out outlet tube from the rear panel, clean it with distilled water and save it with
plastic bag after dry by airing.
4) Cover the connectors of DILUENT, LYSE, DETERGENT and WASTE on the rear
panel with caps which are taken out at initial installation.
5) Disconnect the power cord of analyzer and save it in plastic bag. Place the analyzer
and components in plastic bags into the shipping box.
  
  Page 104
 
CHAPTER 10 Service 

Routine care and regular maintenance are essential to keep optimal performance, minimize
system problems and prolong the life span.
This chapter introduces the Service function, with which operator may monitor the system
status, valve and motor status etc.. More information is available at the Customer Support
Centre.

CAUTION: Incorrect maintenance may lead to impairment of analyzer. Please maintain the
analyzer according to this manual.
NOTE: If there is any problem which Is not discussed in the manual, please contact the the
Customer Support Centre.

10.1 System Check 

Click "Func" at main menu screen, select "Sev", input "2006" in the pop-up dialog box to
enter the System Check screen.

10.1.1 System Status Check 

The System Status Check screen presents the current status information for
example temperature, constant-current source voltage, 5V voltage, HGB zero voltage,
HGB background voltage, WBC aperture voltage, RBC aperture voltage etc.. See
Figure 10 -1.
  
  Page 105
 

Figure 10-1 System Status Check

NOTE: At System Status Check screen, operator can view the temperatun vacuum etc.
that mention above, but cannot modify.

Click "Back" to return to the main menu screen

10.1.2 Valve Check 

At Valve Check scre(en (see Figure 10-2), operator can check if the valves are in normal
condition.
  
  Page 106
 

Figure 10-2 Valve Check

At Valve check screen, click valve buttons, the corresponding result will be displayed in
result list. See Fugure 10-3.

Click “Back” to return to the main interface of the system.

  
  Page 107
 
10.1.3 Motor Check 
 

At motor Check screen, operator can check if the motors are in normal condition. At the
screen, click motor buttons, the corresponding result will be displayed in result list. See
Figure 10.4

Figure 10-4 Motor Check

  
  Page 108
 
10.2 System Log 

Click “Func” at main menu screen, select “Sev”, input “6666” in the pop-up dialog box to
enter the System Log screen as Figure 10-5 shows:

Figure 10-5 System Log

  
  Page 109
 
10.2.1 System Log Query Mode 

Data Query:

Choose the begin date and end date on System Log Screen, then click “Rev”, the query
results will be displayed in the list box. As shown in Figure 10-6.

Figure 10-6 Date Query

Event Query

On System Log screen, cancel Date optio in check box in top left corner, then check Event
query mode, select intended event in dropdown options. Click “Rev”, result will be displayed
in list as Figure 10-7 and Figure 10-8.
  
  Page 110
 

Figure 10-7 Event Query

Figure 10-8 Event Query

  
  Page 111
 
After getting the query results, operator can perform following operations:

1) The number of total pages and current page number will be automatically displayed
on the list box

2) If query are in a large quantity and cannot be displayed in one page, pess Pgprv and
Pgnex buttons to view the results in previous or next page.

3) Select a record, click “Del”, then it will be deleted.

4) Press “DelAll”m all the records will be deleted

5) Click “Back” to return to the main screen.

  
  Page 112
 
CHAPTER 11 Troubleshooting 

This Chapter gives instructions for identifying, troubleshooting and correctingfaults. If

malfunction cannot be solved according to this chapter or more information is needed,
please contact the Customer Support Centre.

11.1 Troubleshooting Guidance 

The Troubleshooting Guidance is designed to assist the operator to identify and resolve
analyzer faults. It also gives instructions on obtaining technical assistance from the
Customer Support Centre. The first step is to understand the normal operation and
preventive maintenance of analyzer. Rich experience is essential for troub eshooting Logical
troubleshooting can be divided into 3 steps:

Step 1 Fault Identification:

Operator should have the ability to identify fau4t cause and understand proper operation
well. Accurate fault identification is essential for troubleshooting.

Step 2 Fault Isolation:

Fault Isolation means further classifying the problem. Analyzer’s faults are generally
divided int three categories:

a) Faults related te to hardware

b) Faults related te to software
c)Test fault related to sample analysis

Hardware and software faults can only be corrected by an authorized engineer. While the
test fauIts related to sample analyses can be corr ected by operator with assistance from
the engineers.

Step 3 Corrective Action:

Corrective Action means taking appropriate action to correct the fault. If operator is able
to correct faults with or without technical assistance from the engineer, time spent can
be reduced greatly.
  
  Page 113
 
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 
 

Familiar faults corrective action are listed as follows. If faults still cannot be corrected
according to this chapter, or more technical assistance is needed, please contact with
NeoMedica Customer Support Centre.
  
  Page 114
 
11.4.1 Faults Related to Reagents 

Fault Probable Cause Corrective Action

Lyse is run out 1.Check that if the lyse is run out.

Lyse empty or lyse inlet tube is 2.Perform Maint→Prime Lyse.
blocked. 3.If fault still occurs, please contact with NEOMEDICA.

1.Check that if diulent is run out.

Diluent is run
Diluent empty 2.Perform Maint→Prime Diluent.
out
3.If fault still occurs, please contact with NEOMEDICA.

1.Check that if the detergent is run out.

Detergent is 2.Perform Maint→Prime Detergent.
Detergent empty
run out. 3.If the fault still occurs, please contact with
NEOMEDICA.

Waste 1.Check that if the waste container is full.

container is full 2.Check that if the sensor is wet or short circuit.
Waste full
or waste 3.If the fault still occurs, please contact with
sensor is in fault. NEOMEDICA.

11.3.2 Faults Relate to Vacuum 

Fault Probable Cause Correction Action

Pressure of vacuum 1.Click “Sev”, input password “2006” to enter System

chamber did not Check screen, ensure the vacuum items are in normal
Low Vaccum reach standard value condition.
in time 2. .If the fault still occurs, please contact with
NEOMEDICA.
  
  Page 115
 
11.3.3 Faults Relate to 5V Voltage 
 

Fault Probable Cause Correction Action

1.Click “Sev”, input password “2006” to enter System

Power supply module Check screen, ensure the 5V Voltage is in normal
5V Voltage
is abnormal condition.
Problem
2. .If the fault still occurs, turn off the power, and
contact with NEOMEDICA.

11.3.4 Faults Relate to Test Results 

Fault Probable Cause Correction Action

1. Check that if the diluent is contaminated or

Diluent is
overdue.
contaminated or
High 2. Enter Mainain screen and perform “Rinse Fluidics”;.
overdue;
background 3. If the fault still occurs, Perform Prime Fluidic at Maintain
Diluent tube or cups
value screen with probe detergent. Run a background test again to
are
check if the fault had been cleaned;.
contaminated
4. If the fault still occurs, please contact with NEOMEDICA.

1. Click “Sev”, input password “2006” to enter System Check

HGB
HGB screen, check “HGB_BACK” and “HGB_ZERO”;.
background
inaccuracy 2. If the “HGB_BACK” and “HGB_ZERO” are out of range,
voltage jump
contact with the NEOMEDICA to modify the value.

Ruby aperture 1. Perform “Cauterize Aperture” or” Flush Aperture” in the

clogged; WBC Maintain screen, and then run a background test to check
WBC clog counting time the counting time.
or RBC clog abnormal; 2. If fault still occurs, perform Prime Fluidics in Maintain
solenoid valve screen;.
problem 3. If fault still occurs, please contact with NEOMEDICA.

Diluent or
detergent run
1. Check if the diluent or detergent has been run out.
out or deficient
WBC bubble 2. Check the reagent tubing connection, prevent leakage.
Reagent tubing
or RBC bubble 3. Perform Rinse Fluidic in Maintain;.
loose leads to
4. If the fault still occurs, please contact with NEOMEDICA.
leakage
  
  Page 116
 
11.3.5 Faults Relate to Hardware 

Fault Probable Cause Correction Action

1.The power wire is
not connected well 1. Check the power wire connection.
No response with the power 2. Check whether the fuse has burned out.
when startup socket. 3. If the fault still occurs, turn off the power, and contact with
2.The fuse may be NEOMEDICA.
burnout.

1.Moto connecting
wire is loose;
1. Click “Sev”, input password “2006” to enter System Check
2.Travel Optocoupler
Motor sounds screen, ensure the motor items are in a normal condition;
problem.
is abnormal 2 If fault still occurs, turn off the power, and contact with
3.Motor problem;
NEOMEDICA.
4.Moto drive circuit
problem.

1. Perform Drain Cups to empty the liquid both sides of the

ruby aperture and dismount the ruby aperture and brush it
with probe detergent or enzyme, Then wash it with distilled
1.Ruby aperture
Counting time water. When the ruby aperture has been reinstalled, run
clogged.
is to long or no several background counts to check whether it is block
2.Valve is not
counting time aging.
working.
2. Click “Sev”, input password “2006” to enter System Check
screen, ensure the vale items are in a normal condition;
3. If the fault still occurs, please contact with NEOMEDICA.

11.3.6 Faults Relate to Temperature 
 

Fault Probable Cause Correction Action

1.Click “Sev”, input password “2006” to enter System
Check screen, verify the temperature in System Status
Temperature is
Check.
abnormal or
Temperature is 2. If working temperature is out the acceptable range:
temperature sensor
abnormal 15°C÷30°C, improve working environment to meet the
has problems.
requirement;
2. .If the fault still occurs, turn off the power, and
contact with NEOMEDICA.
  
  Page 117
 
CHAPTER 12 Precautinos, Limitations and Hazards 
 

Improper operation will lead to errors, event damage to operator or other peaple. Therfore, a
perfect criterion should be designed to the service conditions to reach the optimal
performance.

12.1 Limitations 
 

1) The instrument is designed for in vitro diagnostic use.

2) All the relevant personnel for operation, shipment, installation or maintenance etc. should
strictly follow the requirements in this manual, otherwise non-standard operation may lead to
fault and user will lose the right of free service.

3) Using reagents, controls and calibrators which is not specified by NeoMedica, may lead to
faults even accident. User cannot get free service from NeoMedica in this condition.

4) Repair can be done only with permition of NeoMedica. Please, use components specified
by NeoMedica for replacement. For the problems derived from illegal operation, we will not
offer free service.

5) Please follow the recommended maintenance schedules and procedures outlined in

Chapter 9. Fail to comply with the requirement will shorten the life span and affect the test
results even cause accident. We will not offer free service in this condition.

12.2 Location Limitations 
 

1) Initial installation should be done by qualified engineer authorized by NeoMedica.

2) Place the analyzer on a stable and level operating platform. Please pay attention to the
following:

• Keep away instrument from direct sunlight.

• Keep away instrument from the air outlet to avoid temperature extremes.

• Keep away instrument from drying oven, centrifuge, x-ray equipment, copiers or
ultrasonic cleaner.

3) Place the reagent containers at the same level of the analyzer.

4) The installation area of analyzer and reagents is 2m2 Please keeping at

least 40cm distance from surrounding objects to ensure ventilation.
  
  Page 118
 
Adequate space should be left for maintenance and service.
5) Please perform following operations prior to initial use:
- Ensure liquid connection is proper and stable.
- Ensure tubes are not bending.
- Ensure reagents are flowing fluently.
- Ensure wastes are being drained into a suitable waste container.
6) Do not disconnect any electrical connection while power is ON. Ensure the
analyzer is grounded well to prevent electrical interference and ensure
safety.
CAUTION: Service repairman who is not authorized by us or unqualified is not
allowed to remove the screws on the shell.

12.3 Personal Protection and Infection Control 

 
1) Follow required laboratorial or clinical procedures during daily operation or
maintenance. Wear gloves, lab clothing and safety glasses to avoid direct contact with
the samples.
2) Consider all clinical specimens, controls and calibrators etc. that contain
human blood or serum as potentially infectious. Wear standard laboratorial clothing,
gloves and safety glasses and follow required laboratorial or
clinical procedures when handling these materials. Do not smoke, eat or
drink in working area. Do not suck or blow the tubing.
3) Blood samples and waste have potential biological and chemical hazard,
thus operator should handle with care. Follow relevant local regulations to
clean, dispose and discharge the waste.
4) Follow directions to store reagent, calibrators and controls. Reagents
should be kept away from temperature extremes. Customer should set up
and execute effective safekeeping measurement to prevent expired use,
deterioration, misapplication or ingestion.

 
CAUTION: Reagent will freeze if being stored below 0°C . Discard the reagent if iit was
frozen.
CAUTION: Keep away from direct sunlight. Seal the cap of the container and minimize
the pore size to avoid evaporation and contamination.
  
  Page 119
 
APPENDIX A: Instrument Specifications 
 

 
Dimension and Weight Environmental Requirements
Dimension: Temperature: 15°C~35°C  

650mm(L)x470mm(W)x600mm(H) Relative Humidity: ≤90%RH  

Weight: 23Kg Barometric Pressure:
60kPa~106kPa

Transport and Storage Specifications Power Specifications

Temperature: -10°C ~55°C Power Supply: AC 100V~240V
Relative Humidity: ≤95%RH Frequency: 50/60Hz
Barometric Pressure: 50kPa~106kPa Power: 100VA-180 VA
Fuse: 250V/3A

Scope of Application
Venous blood, peripheral blood of human being

Appearance Specifications
Display: 10.4-inch LCD
Language: English
Parameter: 21 parameters and 3 histograms
Indicator: Status Indicators/Work Mode Indicator!
System Alert: Alert message/Alert beep
Ports: Power Receptacle
Printer Ports

RS-232 Port
PS/2 Port
USBPorts

Recorder Specifications
Recorder Width: 4Bmm
Paper width: 57.5mm
Paper Roll Diameter: 53mm
Print Speed: 25mm/S
  
  Page 120
 
Sample Volume
Whole Blood Mode for Venous Blood: Venous Blood 10 µL
Pre-diluent Mode for Peripheral Blood: Capillary Blood 20 µL
Whole Blood Mode for Peripheral Blood: Capillary Blood 10 µL

NOTICE: Sample dosages can be different according to analyzer version.

Reagent Volume for Single Sample

Diluent: 31mL
Detergent: 8mL
Lyse: 0.7mL
NOTICE: Sample dosages can be different according to analyzer version.

Background Results
WBC≤0.2x109/L ; RBC≤02x1012/L ; HGB≤1g/L ; PLT≤10x109/L

Carryover
WBCS≤.0.5%; RBC≤0.5%; HGB≤0.5%; HCT≤0.5%; PLT≤0.5%

Accuracy

Table A-1 Accuracy Specifications

Parameter Acceptable Range (%)

WBC ≦±2.0%
RBC ≦±1.5%
HGB ≦±1.5%
MCV ≦±0.5%
HCT ≦±1.0%
PLT ≦±4.0%

 
  
  Page 121
 
Precision

Table A-2 Precision Specifications

Parameter Precision Range Acceptable

Limits（CV%）
WBC 4.0 x109 /L ~15.0x109 /L ≤2.0%
RBC 3.00 x1012 /L ~6.00x1012 /L ≤1.5%
HGB 100 g/L ~180 g/L ≤1.5%
PLT 100 x109 /L ~500x109 /L ≤5.0%
HCT / 35%~50% ≤2.0%
MCV 70 fL ~120 fL ≤1.0%

Linearity

Table A-3 Linearity Specifications

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%
  
  Page 122
 
Appendix B: Instrument Icons and Symbols 
 

Caution

Be ware of electric shock

Protect from heat and radioactive

sources

Equipotentiality

In vitro diagnostic medical device

Lot number

Serial number

Use by

Production Date

Manufacturer
  
  Page 123
 
APPENDIX C: Communication 

The system transfers sample data and analyzer information to outer computer through RS-232
COM. Communication can be done automatically after analysis or manually when the analyzer is
in idle mode. This appendix explains the settings of communication parameters and data
communication formatter for easy operation.
Before communication, please ensure the analyzer has connected with outer computer through
appropriate COM.

Communication can be done in hexadecimal format or ASCII format.

1. Hexadecimal Format Communication 
 

1.1 Data Link MAC Sublayer Parameters Convention 
 

Baud Rate: 115200 Parity Digit:None

Data Bit: 8 bits Stop Bit: 1 bit

1.2 Data Link Layer Frame Format 
 

1.2.1 Frame Format 
STX LENGTH Messege ETX LRC

1.2.2 Meaning of Fields or Control Fields 
 

Name Meaning Value

STX Start of Text 0x002

ETX End of Text 0x003

Message Sending Message Determine by Message content

LENGTH Length (2 bytes) Determine by Message length

LRC Checksum Determine by the content among

STX and ETX, exlude STX.

 
  
  Page 124
 
1.2.3 Convention 
Comply with Big-Enddian format, high byte is prior when transferring.

1.3 Message Field Structure 

1.3.1 Message Structure 
TYPE DATA
 

Field Definition:

Field Lenght
1 TYPE 1
2 DATA XX

TYPE Value:

Type Value
TRANS_CONDITON 0x42

1.3.2 DATA Field Definition 
DATA Type (1Byte) DATA Content (depends on specific DATA Type)

TYPE Value of DATA Field

DATA Type Value Definition Receive Transmit

CON_TRANS 0x01 Request online status Yes
TRANS_CON 0x02 Transmit online status Yes

DATA Field Content:

If TYPE value of DATA field is TRANS_CON and the opposite party can receive 0x01
message which sent by us, it means online is normal.
  
  Page 125
 
2. ASCII Format Communication 
 

2.1 Message Transfer Format 

Message transfer formats are <SB> ddddd <EB><CR>.

<SB> means the start of massage and its corresponding ASCII sign is <VT>, namely
0x0B;

<EB> means the end of message and its corresponding ASCII sigh is <FS>, namely
0x1C;

<CR> means the confirmation of termination and the field mark of different
message,namely 0x0D;

ddddd is the actual transfer content. It includes several fields, each field will
end with <CR>, namely 0x0D.

2.2 Massage Grammar 

| Field mark
^ Component mark
& Child component mark
~ Repeat mark
I Escape character

2.3 Data Type 

CX extended composite id which check digit

CE code element
CM composite
CQ composite quantity with units
DR datetime range
DT data
DLN driver's license number
El entity identifier
HD hierarchic designator
FN family name
FT formatter text
  
  Page 126
 
IS coded value for user-defined tables
ID coded value for HL7 tables
JCC job code
NM numeric
PT processing type
PL person location
ST string
SI sequence ID
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 telecommunications number
VID version number

2.4 Message Type 
 

The structure of message is as follows:

The structure of message is as follows :

MSH / /Message Header
{
[PID] / Patient Data
{
OBR //Medical Advice

[OBX] //Inspection Result

}
  
  Page 127
 
Definition of MSH (Message Header):

Number Field Type Length Remark

1. Field mark ST 1

2. Encoding chars ST 4

3. Sending Application EI 180

4. Sending Facility EI 180

5. Receiving Application EI 180

6. Receiving Facility EI 180

7. Date Time Message TS 26

8. Security ST 40

9. MessageType CM 7

10. Message Control ID ST 20

11. Processing ID PT 3

12. Verson ID VID 60

13. Keep

14. Keep

15. Keep

16. Keep

17. Keep

18. Encoder Encoding (with

UNICODE)

Example:

MSH|^~\&|UT|UT-3O2O|LIS|PC|20100930100436||ORU^ROI|UT...I3LD|P/23.1||||||UNICODE
  
  Page 128
 
Definition of PID(Patient Data) Field:

Number Field Type Length Remark

1. Set ID PID SI 4 Confirm different fields,

generally set 1

2. Patient ID EI 20

3. Patient Identifier List CX 20

4. Alternate Patient ID CX 20

5. PatientName XPN 48

6. Mother Maiden Name XPN 48

7. Date/Time of Birth TS 26

8. Sex IS 1 M or F

9. Patient Alias XPN 48 Keep

10. Race CE 80 Keep

11. Patient Address XAD 106 Keep

12. Country Code IS 4 Keep

13. Phone Number XTN 40 Keep

14. Phone Number Bus XTN 40 Keep

15. Primary Language CE 60 Keep

16. Mrtial Status CE 80 Keep

17. Religion CE 80 Keep

Basically, the Latter

parts do not need to fill

Example: PID|1|1010051|A1123145/15/Jame||19811011|M
  
  Page 129
 
OBR Field:

Number Field Type Length Remark

1. Set ID OBR SI 4 Confirm different

fields, generally set 1

2. Placer Order Number EI 22

3. Assigned Patient Location EI 22

4. Universal Service ID CE 200

5. Priority ID 2

6. Requested DatTime TS 26 Set null

7. ObservatiomDateTime TS 26

8. ObservatiomDateTime end TS 26 Set null

9. Collection Volume CQ 20 Set null

10. Collector Identifier XCN 60 Set null

11. SPE ActionCode ID 1 Set null

12. Danger Code CE 60

13. Relevant Clinical Info ST 300 Clinical information,

diagnosis

14. SPE Received DateTime TS 26

15. SPE Source CM 300 Blood, urine or others

16. Ordering Provider XCN 120

17. OrderCallback Phone XTN 40 Set null

18. Placer Field1 ST 60 Inspection applicant

19. Placer Field2 ST 60 Set null

20. Filer Field1 ST 60 Set null

Do not need to fill Set null

OBR/1/1010051|OOOOO1|UT^UT-3020|/20101010093020|2010101009350 0||||||
Jaundice|/BLD/Tom//011
  
  Page 130
 
OBX Field:

Number Field Type Length Remark

1. Set ID OBX SI 4 Confirm different fields,

generally use 1 or null

2. Value Type ID 3 NM indicates number type,

ST indicate value type

3. Observation Identifier CE 590 Observation Identifier or

Item ID

4. Observation SubID ST 20

5. Observation value ST 65535 Test result

6. Units CE 90

7. References Range ST 90

8. Abnormal Flags ID 5 Value mark: L H N

9. Probability ID 5 Set null

10. Nature of Abnormal ID 2 Set null

Test

11. Observe Status ID 1 Observe results and take

as final result

12. Date Last Observe TS 26 Set null

13. User Definied Access ST 20 Original result, such as

Checks absorbance

14. DateTime TS 28 Use for biochemical result

15. Producer ID

16. Responsible Observer

17. Observation Method CE 60 Use for biochemical

analyzer

A complete ASCII data example:

<SB>
MSH|^~\&|[CompanyName]/[InstrName]|LIS/PC/[ResultTime]||ORU^ROI|[
lnstrType]|P|2.3.1||/|||UNICODE<CR>
  
  Page 131
 
PID|[PatType]|[PatID]|[PatBarCode]/[PatBedCode]/[PatName]//[PatBirth]|[
PatSex]<CR>
OBR|[SampleType]/[REQID]/[SamplelD]/[CompanyName]^[lnstrName]||[S

ampleTime]|[StartTime]/|/|//[Symptom]||[SanpleType]/[SendDOCName]|/[Send
DP]<CR>

OBX|[ResultType]|[ValueType]/[ltemlD]/[ltemName]/[TestResult]/[Unit]/[Co
nsultValue]|[FIag]//|F|///[DocDP]/[DOCName]|<CR>
OBX/1/NM/[ItemlD]^LeftLine//[TestResult]//|/|/F////[DocDP]|[DOCName]|<C
R>
OBX|1|NM/[ltemlD]^RightLine/|[TestResult]|||//|F/|||[DOCDP]/[DOCName]/
<CR>
OBX\1/ED/[ ltemlD]//[lnstrlD]^Histogram^32Byte^HEX^[TestResult]|/||/|F/||
/[DOCDP]|[DOCName]/<CR>
<EB>

3 Communication Operations

If choose hexadecimal as transmission mode, the system will send data in hexadecimal
format. Likewise, choose ASCII, the system will send data in ASCII format.
If automatic transmission is on, then after finishing each analysis, the system will transmit
data through COM automatically. If you do not need, please choose off in setting interface.
Users can press "Trans." in main menu screen to transmit data.