RT-7200 Auto Hematology Analyzer User's Manual
RT-7200 Auto Hematology Analyzer User's Manual
Please reserve all packing materials for storage, transportation and return to fctory for
maitenance.
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.
z Install, adjust, update and repaire are done by Rayto authorised person.
Note
z This instrument shall be operated by prefessional of medical inspection or trained
doctor, nurse and experimentalist.
Warning
z If 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.
z The 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
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
Biological risks
Serial number
Manufacturer
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.
z If 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.
z The 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.
z The 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.
z The 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.
z When 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
z The reagents shall be avoided from contacting with the skins and clothes when
the operation is carried out.
z If 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.
z If 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.
z If the hands or skins are touched with the reagents, they shall be immediately
washed to be clean using a large amount of clear water.
z The 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.
z The power supply and grounding environment of this instrument are assured to
be good and stable.
z The 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.
z When 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.
z DO 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.
z When the peripherals are connected, the power supply must be first cut off, or
the short circuit or open circuit might be caused.
z Do 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.
Contents
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
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
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
11 Troubleshooting ...........................................................................49
1 Instrument Introduction
11
2 Installation
12
2.4 Reagent
The instrument needs to use Lyse, cleanser, diluents for measurement and maintenance. To
ensure accuracy of test result, please use reagents accompanied with instrument.
2.4.1 Connection of Lyse and cleanser
1) From reagent packing carton, take out lyse and cleanser respectively, open the
bottle lids, and place them in instrument reagent booth horizontally.
2) Insert plastic tube marked Lyse into the Lyse bottle and tighten the bottle cap.
3) Insert plastic tube marked cleanser into the cleanser bottle and tighten the bottle
cap.
2.4.2 Connection of diluent
1) Take out diluent catheter from the accessories bag.
2) Connect diluent catheter end to “Diluent” route adapter on rear panel of instrument.
3) Insert the other end of catheter into diluent bottle, and tighten the bottle cap.
2.4.3 Connection of waste
1) Take out waste catheter from accessories bag.
2) Connect waste catheter end to “Waste” route adapter on rear panel of instrument.
3) Clockwise rotate the bottle cap with waste catheter to tighten it on the waste bottle.
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3 Sample test
14
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If select pre-diluted peripheral blood mode, first add 20μl peripheral blood at the diluting cup,
then click “Diluent” button, a message box as following will appear:
1. Put sample cup under sampling needle, press aspiration key, the instrument aspirate
blood sample, wait until sampling needle rises inside instrument, remove sample cup.
2. Instrument begins to analyze sample, frame top message box shows “Testing…”, after
test, parameter, test result and histogram will be shown as follows:
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result.
3.4.6 Print
Before sample test, please set up printer and print format in system setting module, see
detail in Chapter 7 “System Setting”. Click “Print” to print this test result.
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4 Quality Control
Quality control reflects system accuracy and repeatability. Available instrument quality
control program provides reliable and efficient way to check and prevent possible system
error. If there is system error, sample analysis result will be unreliable. To maintain accurate
analysis result, discover and eliminate instrument measurement system error in time, it is
recommended to make regular quality control of instrument.
RT-7200 provides three QC methods, L-J QC, X-B QC and X-R QC.
4.1 L-J QC
In main screen, click “QC” button, choose 20 QC files of “L-J QC”. The system can control
20 parameters at a time. L-J QC uses QC samples for QC analysis.
4.1.1 L-J QC setting
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connect RT-7200 to equipment ready to receive data, start up and set up receiver
software parameters. For setting of instrument transferring terminal parameter, please
refer to Chapter 7 “System Setting”.
z Exit: return to main screen.
4.1.2 L-J QC run
After QC parameter setting of selected QC file is done, QC analysis of this QC file can start.
In main screen, select QC file, enter QC Run screen as shown below:
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The instrument will display 20-parameters QC result, if some parameters are not controlled,
the corresponding column shall be blank.
Send function can transfer part or all of the L-J QC data to external equipment. Use mouse
to click list column, select one group of QC data. Using keyboard Ctrl key or Shift key,
multiple columns can be selected. You can send all data, click “Send” button, open transfer
dialog box as follows:
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4.2 X-B QC
X-B QC does not use QC sample, same as QC of QC sample, it belongs to instrument
quality monitoring method, they can reflect machine inspection quality from different aspects,
and not interchangeable. X-B QC data stem from random sample, not classified according to
disease type. The given value and upper and lower limits comprise a reference range,
observe trend of each lot of X-B values in reference range.
The instrument makes X-B QC of all 20 parameters, quantity of samples for X-B numeric
analysis in each lot is within 20-200, the default is 20.
4.2.1 X-B QC setting
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25
26
points in chart will randomly distributed on both sides of centerline, the farther from
centerline, the nearer to upper/lower control limits, there will be fewer points. Graphic screen
is as follows:
composed of X chart and R chart, reflecting QC data mean and range fluctuation
respectively. Three values on the left of X chart are, from top to bottom: X + A2 R , X ,
X - A2 R , respectively. Three values on the left of R chart are, from top to bottom: D4 R , R ,
k k
D3 R , respectively; where, X = Σ X i /K, X i is mean value of group i, R = Σ Ri /K, Ri is
i =1 i =1
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5 Calibration
Before delivery, all instruments have been subjected to strict test and calibration. But during
transportation and using, test result may drift due to different reasons; instrument calibration
purpose is to ensure test result accuracy.
In order to guarantee instrument test accuracy and get stable and reliable test result,
instrument must be calibrated in following cases.
1. First installation for use and reinstallation at other place.
2. Instrument has been repaired.
3. Deviations in QC results.
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4. In Manual Calibration screen, select sample type, input new calibration coefficient in
calibration input box, input calibration time in calibration time box. If running
auto-calibration, the parameter calibration time will be automatically updated to the time
of automatic calibration.
5. Click “Save” button to save current calibration result. Click “Exit” button, the system will
not save result, and directly return to main screen.
5.3 Auto-calibration
When automatic calibration is selected, after testing calibration sample, the instrument can
automatically calculate new calibration coefficient. Auto-calibration procedure is as follows:
1. Set up calibration sample, select parameters to calibrate;
2. Test calibration sample;
3. Determine calibration coefficient.
Auto-calibration screen is as follows:
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Fig.5-2 Auto-calibration
At first, calibration sample is to be set up, click “Setting” button, open auto-calibration setting
menu, as shown below:
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6 History Data
After test of each sample, the system automatically saves test data; RT-7200 can save
parameter test values and histograms of at most 50000 samples. User can check parameter
test data and histograms of all samples, print, delete, modify and retrieve sample data of
designated condition.
In main screen, click “RESULTS” button, open history data list menu, as shown below:
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34
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7 System Setting
System setting is used to set up system parameters, in main screen, click “Setting”, and go
to System Setting menu as follows:
5. Standby time(mn): in this box, input stand by time, when idle time of instrument
exceed this value on the sample test window, the instrument will stand by. If it is set
zero, it will not stand by.
6. Reagent Alarm: reagent alarm mode by software or sensor.
7.2 Other
Click “Other” button; open the menu as follows:
37
38
39
40
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8 System Information
System message provides several types of message about system; user can check system
status through system message function module.
8.1 System status
On system message menu of main screen, click “System Info” key, the click “system status”,
go to system status menu as follows:
42
running time, in system message menu of main screen, click “Statistic”, it will go to statistic
information menu as below:
43
9 Shutdown
After work every day, you must run shutdown program before turning off instrument power.
During shutdown, the instrument will perform routine maintenance and rinse test tubing.
In main screen, click “Shut down” button, the system will pop up confirmation dialog box as
below:
Warning: Never turn off power directly without running shutdown program.
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10 Service
45
10.2.6 Prime
System will prime automatically during sample test. If you have performed drain operation or
replaced reagent, you shall perform the operation of priming.
1) All reagents: fill diluent, lyse and cleanser into related pipeline.
2) Diluent: fill diluent into related pipeline.
3) Lyse solution: fill lyse solution into related pipeline.
4) Cleanser: fill cleanser into related pipeline.
10.2.7 Cleaning chambers
When you think that the chamber has been polluted or the blank test result keeps
unacceptable, you shall use this function.
10.2.8 Concentrated cleanser soaking
Concentrated cleanser is an alkalescent wash solution. It is used for cleaning pipeline and
chamber. At the service menu, click “Conc. Cleanser Soaking” to perform the concentrated
cleanser soaking procedure. When the system give the message to add concentrated
cleanser, add it manually into the chamber. You shall perform this operation once every
three days.
10.2.9 Check mechanics
In Service menu, click “Check Mechanics” key, open mechanical test menu as below:
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11 Troubleshooting
This chapter describes common faults of instrument and their solutions, if failing to eliminate
faults as per tips in this chapter or needing more detailed data, please contact Rayto
customer service department.
Fault Solution
1) Instrument cannot be ——check if instrument is powered on
started up ——check if power plug gets loose or falls off
——check voltage
2) Instrument cuts power ——check instrument power is connected or not
automatically ——check power cable is loose or not
——power off instrument internal circuit breaker, and restart.
3) No diluent ——replace diluent, from main screen sevice menu, select
reagent prime -> diluent
4) No cleanser ——replace cleanser, from main screen sevice menu, select
reagent prime -> cleanser
5) No Lyse ——replace Lyse , from main screen sevice menu, select
reagent prime -> lyse
6) Waste bottle full ——discard waste.
7) Temperature abnormal ——in software main menu, click “System Info” -> “System
Status”, check environment temperature, if not within
15°C~35°C range, restore instrument ambient temperature
to this range
8) Blank counting value ——reagent is used up or not
higher repeatedly ——reagent is deteriorated or contaminated
——calibrate instrument
——check temperature or pressure if it is normal
9) Parameter test incorrect ——calibrate instrument
——check if sampling needle location is right
——check if there is bubble in fluid syringe, piston slides
smoothly. If there is bubble, please make sure that reagent
tubing connection is normal.
——check solenoid valves if they work normally
10) Printer cannot print ——check printer if there is no paper
——check if normally connected
——check printer setting in system setting
10) QC not in target range ——check reagent validity period
——check setting if it is right, and necessary to modify
parameter.
——make sure that QC process is not contaminated
——test again in other method
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Built-in PCB × ○ ○ ○ ○ ○
Casing × ○ ○ ○ ○ ○
Display
screen
× ○ ○ ○ ○ ○
Optoelectric
component
× ○ ○ ○ ○ ○
Internal wire ○ ○ ○ ○ ○ ○
Ancillary part × ○ ○ ○ ○ ○
○: contents of this toxic/hazardous substance in all homogenous material of the component
are below limit stated as per SJ/T11363-2006 standard.
×: content of this toxic/hazardous substance at least in one homogenous material of the
component is out of limit stated as per SJ/T11363-2006 standard.
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