Rayto RT-7200 User manual

RT-7200
Auto Hematology Analyzer
User’s Manual
Copyright: Rayto Life and Analytical Sciences Co., Ltd.
Address: C&D/4F, 7th Xinghua Industrial Bldg, Nanhai Rd, Nanshan,
Shenzhen 518067, P.R. China
Rev: 1.0e

RT-7200 Auto Hematology Analyzer User’s Manual
How to use this manual
Thank you very much for being the user of RT-7200 Auto Hematology Analyzer.
In order to get best test result, before doing clinical test, you shall be familiar with this
analyzer and its performance. This user’s manual is the using guidline of RT-7200 Auto
Hematology Analyzer from Rayto, including installation, daily test, QC and daily
maintenance.
The functions of instruments with difference versions or configurations may be
different. The content of user’s manual may be different because of upgrade, we will
not give notice seperately. If you have any question, please contact the distributor.
Please reserve all packing materials for storage, transportation and return to fctory for
maitenance.
If any problems come into existence, please contact the distributors
N
No ot te e Prompts, advice or suggestion, using italic.
W
Wa ar rn ni in ng g Warnings must be followed strictly to make sure the normal
performance of instrument and the accuracy of test result.
Declaration
Rayto reserves the Power of Interpretation to this user’s manual.
The figures in the manual is only for demostration, they may be different form the actual
display, please according to the actual display. Unless been authorised by Rayto, No person
or orgnization has the right to copy, modify or translate this user’s manual.
Only that all the following requirements are met, Rayto will be responsible for the safety,
reliability and performance of the product.
zInstall, adjust, update and repaire are done by Rayto authorised person.
zOperation of instrument followed the user’s manual strictly.
zElectric environmentmeet the requirements.
Note
zThis instrument shall be operated by prefessional of medical inspection or trained
doctor, nurse and experimentalist.
Warning
zIf the orgnization which are using this instrument can not finish a satisfactory
maintenance/ repair plan for the instrument, it may cause abnomal fault to the anlyzer
even endanger the health of operator.
zThe analyzer must be operated under the stated conditions, if not, it may cause
abnormal running of instrument, the test results may be not reliable, also it can break
the parts of analyzer even endanger the health of operator.
2

RT-7200 Auto Hematology Analyzer User’s Manual
Main graphical representations used on this instrument
Temperature limitation
Fragile articles
The fragile articles are contained in the transport package, so it
should be handled with care when being transported
Upwards
It indicates that the transport package shall be kept vertically
upward
To be protected from rain
The packaging piece is extensive to the rain
Limit of the number of stacking tiers
It indicates the maximum number of the stacking tiers of the
same package. 3 indicate the limit of the stacking tiers.
Biological risks
This means that the labeled item could lead to personal
injury and/or damage to the analyzer. The symbol is labeled
beside the power outlet and some external interface.
Serial number
In vitro diagnostic medical device.
Manufacturer
Authorised representative in the European community
3

RT-7200 Auto Hematology Analyzer User’s Manual
Warnings and security attentions
This instrument is only provided for in vitro diagnosis, please carefully read the following
warnings before use. They are required to be strictly followed.
Warning: please carefully read the following security attentions before use this
instrument.
zIf the smoke, peculiar smell and sound appears while using, the power supply
must be immediately cut off. Meanwhile, the inspection apply shall be
immediately presented towards the distributors or agents of Rayto company. If
the instrument continues to be used under this circumstance, the misfire, electric
shock or casualties of personnel might be caused.
zThe bloods, reagents and metal pieces shall be avoided from entering the interior
of this instrument, or the short circuit or misfire with smoke generation will be
caused. If abnormality happens, the power supply shall be immediately cut off
and the plug of the power supply is extracted from the power socket. Meanwhile,
the inspection apply shall be immediately presented towards the distributors and
the agents of this company.
zThe operator shall not touch the electronic lines in the instrument; especially
there will be a danger of electric shock when they are touched by a wet hand.
zThe rubber gloves are required to be worn and the prescriptive tools and parts
must be used when the instrument is maintained and checked. When the
operation ends, please wash your hands using disinfection solutions, or the
infection, electric shock or scald might be caused to the part of the skin which
contacts with the bloods.
zWhen the samples are handled, the great care shall be paid and the rubber gloves
must be worn, or the infections might be caused. If the samples enter the eyes or
wounds, they shall be immediately washed using a large amount of clear water
and inspected by the doctor.
Usage of reagents
zThe reagents shall be avoided from contacting with the skins and clothes when
the operation is carried out.
zIf the reagents enter the eyes immodestly, they should be immediately washed to
be clean using a large amount of clear water and inspected by the doctor.
zIf the reagents are wrongly drunk, the help shall be immediately obtained from the
doctors and simultaneously a large amount of water shall be drunk so as to vomit
the reagents.
4

RT-7200 Auto Hematology Analyzer User’s Manual
zIf the hands or skins are touched with the reagents, they shall be immediately
washed to be clean using a large amount of clear water.
zThe waste products such as used test tubes, other instruments and consumables,
etc shall be appropriately handled as the medical waste products or infectious
waste products. If the pollution is caused by bloods, the infection might be
generated by pathogens.
zTake proper protection while replacing reagent
Voltage, connection and grounding of power supply
zThe power supply and grounding environment of this instrument are assured to
be good and stable.
zThe plug of the power supply shall not be inserted into the power socket which is
not available for the voltage requirement stated in the backplate of instrument, or
the misfire or electric shock might be caused.
zWhen the instrument is installed, the power supply cable and adapter as
accessories attached to the machine must be used and the good grounding shall
be assured, or the misfire or electric shock might be caused.
zDO NOT damage the insulation protection skins of the power cord. DO NOT pull
the power cord with efforts or hang heavy articles on it, or the short circuit or
open circuit might be caused.
zWhen the peripherals are connected, the power supply must be first cut off, or
the short circuit or open circuit might be caused.
zDo not open the side cover or panel while instrument is on, all it may cause
damage to some sensitive parts.
For safety purpose, users are not allowed to refit the instrument.
5

RT-7200 Auto Hematology Analyzer User’s Manual
Contents
How to use this manual ......................................................................2
Main graphical representations used on this instrument ....................3
Warnings and security attentions .......................................................4
1 Instrument Introduction....................................................................9
1.1 Product introduction.................................................................................... 9
1.1.1 Product name: Auto Hematology Analyzer .......................................................... 9
1.1.2 Model: RT-7200 ................................................................................................... 9
1.1.3 Test items............................................................................................................... 9
1.2 Product technical parameters ..................................................................... 9
1.3 Instrument composition and structure......................................................... 9
1.3.1 Front view ............................................................................................................ 10
1.3.2 Rear view ............................................................................................................. 10
2 Installation .....................................................................................12
2.1 Instrument unpacking................................................................................ 12
2.2 Installation environment ............................................................................ 12
2.3 Power requirement ................................................................................... 12
2.4 Reagent .................................................................................................... 13
2.4.1 Connection of Lyse and cleanser ......................................................................... 13
2.4.2 Connection of diluent ........................................................................................... 13
2.4.3 Connection of waste ............................................................................................ 13
2.5 Connection of keyboard, mouse ............................................................... 13
2.6 Connection of external printer................................................................... 13
3 Sample test ...................................................................................14
3.1 Preparation before startup ........................................................................ 14
3.2 Startup ...................................................................................................... 14
3.3 Blood sample collection ............................................................................ 15
3.3.1 Venous blood collection ....................................................................................... 15
3.3.2 Peripheral blood collection ................................................................................... 15
3.3.3 Blood sample mixing............................................................................................ 15
3.4 Blood sample analysis .............................................................................. 15
3.4.1 Sample data edit .................................................................................................. 16
3.4.2 Blood sample counting......................................................................................... 17
3.4.3 Parameter prompt message................................................................................. 18
3.4.4 Histogram prompt message ................................................................................. 19
3.4.5 Adjust histogram .................................................................................................. 19
3.4.6 Print ..................................................................................................................... 20
6

RT-7200 Auto Hematology Analyzer User’s Manual
4 Quality Control...............................................................................21
4.1 L-J QC ...................................................................................................... 21
4.1.1 L-J QC setting ...................................................................................................... 21
4.1.2 L-J QC run ........................................................................................................... 22
4.1.3 L-J QC list ............................................................................................................ 22
4.1.4 L-J QC chart......................................................................................................... 23
4.2 X-B QC ..................................................................................................... 24
4.2.1 X-B QC setting ..................................................................................................... 24
4.2.2 X-B QC list ........................................................................................................... 24
4.2.3 X-B QC chart........................................................................................................ 25
4.3 X-R QC ..................................................................................................... 26
4.3.1 X-R QC setting..................................................................................................... 26
4.3.2 X-R QC run .......................................................................................................... 26
4.3.3 X-R QC list ........................................................................................................... 27
4.3.4 X-R QC chart ....................................................................................................... 27
5 Calibration .....................................................................................29
5.1 Preparation before calibration................................................................... 29
5.2 Manual calibration..................................................................................... 29
5.3 Auto-calibration ......................................................................................... 30
6 History Data...................................................................................33
7 System Setting ..............................................................................36
7.1 General setting ......................................................................................... 36
7.2 Other......................................................................................................... 37
7.2.1 User setting.......................................................................................................... 37
7.2.2 Normal limits ........................................................................................................ 38
7.2.3 Panic limits........................................................................................................... 38
7.2.4 Units..................................................................................................................... 39
7.2.5 Communication .................................................................................................... 39
7.2.6 Department information........................................................................................ 40
7.2.7 Doctor information................................................................................................ 40
8 System Information........................................................................42
8.1 System status ........................................................................................... 42
8.2 System log ................................................................................................ 42
8.3 Statistic information................................................................................... 42
9 Shutdown.......................................................................................44
10 Service ........................................................................................45
10.1 Routine maintenance .............................................................................. 45
7

RT-7200 Auto Hematology Analyzer User’s Manual
10.1.1 Startup and shutdown process ........................................................................... 45
10.1.2 Automatic rinse .................................................................................................. 45
10.1.3 Clean instrument surface ................................................................................... 45
10.2 Maintenance program............................................................................. 45
10.2.1 Back flush .......................................................................................................... 45
10.2.2 High voltage pulse.............................................................................................. 45
10.2.3 Drain chambers.................................................................................................. 45
10.2.4 Drain pipeline ..................................................................................................... 45
10.2.5 Remove Blockage.............................................................................................. 45
10.2.6 Prime.................................................................................................................. 46
10.2.7 Cleaning chambers ............................................................................................ 46
10.2.8 Concentrated cleanser soaking.......................................................................... 46
10.2.9 Check mechanics............................................................................................... 46
10.2.10 Debug .............................................................................................................. 47
10.2.11 Engineering ...................................................................................................... 47
10.2.12 Machine reset .................................................................................................. 47
10.2.13 Stop use........................................................................................................... 47
10.2.14 Replace reagent............................................................................................... 48
11 Troubleshooting ...........................................................................49
Appendix Name and concentration of toxic and hazardous
substance or element in product ......................................................50
8

RT-7200 Auto Hematology Analyzer User’s Manual
1 Instrument Introduction
1.1 Product introduction
1.1.1 Product name: Auto Hematology Analyzer
1.1.2 Model: RT-7200
1.1.3 Test items
This analyzer is using impedance principle (colorimetry for hemoglobin measurement) to
categorize and count blood cells in blood. Test items are shown in Table 1-1.
Table 1-1
Full English name English abbreviation Unit(Default)
White blood cell count WBC 109/L
Lymphocyte count LYM# 109/L
Intermediate cell count MID# 109/L
Granulocyte Cell count GRA# 109/L
Lymphocyte percentage LYM% %
Intermediate cells percentage MID% %
Granulocyte Cells percentage GRA% %
Red blood cell count RBC 1012/L
Hemoglobin content HGB g/L
Hematocrit HCT %
Mean corpuscular volume MCV fL
Mean corpuscular hemoglobin MCH pg
Mean corpuscular hemoglobin
concentration
MCHC g/L
Red cell distribution width SD RDW-SD fL
Red cell distribution width CV RDW-CV %
Platelet count PLT 109/L
Mean platelet volume MPV fL
Platelet distribution width PDW %
Plateletcrit PCT %
Platelet–large cell ratio P-LCR %
White blood cell histogram WBC Histogram
Red blood cell histogram RBC Histogram
Platelet histogram PLT Histogram
1.2 Product technical parameters
Test principle: WBC/RBC/PLT: Impedance method; HGB: colorimetry
Aspiration volume: 9.8μL(Whole Blood), 9.8μL(Anticoagulant Peripheral
Blood), 20μL(Pre-diluted Peripheral Blood)
Test rate: About 2 min /ea.
Working environment: 15°C～35°C, relative humidity ≤80%
Store environment: 0°C～40°C, relative humidity ≤85%
Power supply: a.c.110V-220V, 50/60Hz
Input power: 96WATTS
1.3 Instrument composition and structure
The analyzer is composed of chamber, tubing system, computer control system, and
software.
9

RT-7200 Auto Hematology Analyzer User’s Manual
1.3.1 Front view
Fig.1-1 Front view
①Display screen: Display the software interface
②Indicator light: green at startup, turn red when starting sample test, turn green after test.
③Feed key: built-in printer feeds paper outward
④Aspiration key: in sample analysis, press this key, the instrument will aspirate sample
⑤Printer cover: print paperinstalling position for built-in printer
⑥Sampling needle: use sampling needle to aspirate sample into chamber
⑦Aspiration key: in sample analysis, press this key, the instrument will aspirate sample,
function the same as key ④
1.3.2 Rear view
Fig.1-2 Rear view
1) Parallel port: printer interface
2) USB port 1
3) USB port 2
4) Network interface 1
5) Network interface 2
6) RS-232 serial port: to connect with data receiving devices
7) Keyboard interface: PS/2 keyboard interface
10