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Users Manual
Contents:
Chapter 1 Introduction
computation)
1.2.4 Wavelength: 340, 405, 510, 546, 578, 6302nm; custom wavelength F1
and F2 may be mounted by two wavelengths from 330 to 800nm.
1.2.5 Half bandwidth: 340 wavelength8nm, other wavelengths 6nm.
1.2.6 Light source: halogen lamp, 6V/10W, working lifespan 3000hours,
standby life4000hours.
1.2.7 Temperature control: room temperature, 25, 30, 37 0.2C; fluctuant
range: 0.2C.
1.2.8 Flow cell (colorimetric cell): 30l ceramic body with quartz glass window
colorimetric cell.
1.2.9 Sampling volume: 200-3000l.
1.2.10 Cross contamination: 1%.
1.2.11 Reproducibility: 0.005 Abs, CV 0.3%.
1.2.12 Stability: 0.005Abs/hour.
1.2.13 Storage capacity: 100 testing items, 1060 test results, 31 days quality
control.
1.2.14 Data output: built-in 40 mm high-speed thermal matrix printer; RS232
interface.
1.2.15 Main unit interface: 320240 dots LCD graphic touch screen.
1.2.16 Ambient conditions: temperature 5 - 40C, humidity: 90%
1.2.17 Power supply: AC, 220 10% Volts, 50 1 Hz., 120VA
1.2.18 Dimensions: 460(L) 330(W) 140(H)mm
1.2.19 Weight: 8Kg.
1.2.20 Safety type: I (B).
1.2.21 Host computer: accord with standard of GB4943.
Fuse
RS 232 Connector
Contrast Knob
2.3 Guarantee:
2.3.1 All analyzers are warranted for a period of one year commencing from
the date of the shipment of the analyzer.
2.3.2 This warranty does not cover any defect, malfunction, or damage.
a. Accident, neglect or willful mistreatment of the product;
b. Failure to use, operate, service, or maintain the product in accordance
with the applicable User's Manual and Service Manual;
c. Use of reagents or chemicals of corrosive nature.
2.4 Unpack the package box, check the accessories specified in packing list
ensuring they are present without damaged.
2.5 The instrument must be located in a well ventilated area, on a level surface and
away from direct sun-light and strong magnetic fields.
2.6 Check external electric supply to make sure it is accord with the rated voltage +/-
10%.
2.6.1 Connect the power cable and the ground wire to the analyzer.
2.6.2 Pull out and extend the Aspiration tube to its proper length.
2.6.3 Connect waste liquid pipe to its outlet. Put the end of the pipe into waste
bottle which should be prepared by the end user.
2.6.4 Insert the plug into the socket, connect the ground cable and switch on.
2.6.5 Installation of peristaltic pump tube:
2.6.6 Open maintenance cover. (If users find that peristaltic pump tube is
loose install it as follows).
Liver function
Kidney function & Ions
Glucose & Blood fat
Cardiac muscle enzyme range
& others
Self-defined items
Return
Figure 3
Figure 4
2.7.1 Press the mark on the printer cover lightly, push the printer cover
backward, and take out the paper reel from the rack.
2.7.2 Remove the package from the paper, cut the head of paper into V
shape then insert the paper into the slot.
2.7.3 Check the reel and make sure it had been properly located.
2.7.4 Press the paper-advancing key on the left hand of printer until the paper
comes out about 10cm. Press the paper-advancing button again and it
stops.
2.7.5 Close printer cover.
3.1 The Analyzer has 41 built-in routine item names with programmed parameters.
There is no need to configure again if you use the reagent recommended by the
manufacturer after start-up. Simply follow the manufacturers instructions when
preparing reagents.
3.2 If you need to add or modify parameters, please follow below steps:
3.2.1 in the Classification of test items, press Return key and go back to
main menu: (See figure 5)
Sapphire 120
Main Menu
Figure 5
3.2.2 Press Edit item key it will enter the interface of select classification
of items as followed: (See figure 6)
Liver function
Kidney function & Ions
Glucose & Blood fat
Cardiac muscle enzyme range
& others
Self-defined items
Return
Figure 6
GPT/ALT TP
GOT/AST Al b
ACP FB
ALP NH3
T-Bil -GT
D-Bil TTT
CHE Return
Figure 7
3.2.4 Then press any of the items names, e.g., ALT/GPT, the screen
displays as followed. (See figure 8)
Figure 8
3.3 When using other reagents you can modify parameters as followed steps:
3.3.1 Press respectively method, Filter 1, sample volume... etc., and high
light the content of [ ].
3.3.2 Select or Input value by pressing Up or Down; move decimal or
number place by pressing Left or Right.
3.3.3 Press Save after modification, otherwise, the input parameters will not
be stored.
3.4.2 Delay time: in the kinetic assay and two-point assay, it is the period
before stable reaction. Please refer to reagent insert sheets for the
setting. In other assays, it is the stable time after reagent is sucked, 2
seconds is recommended.
3.4.3 Measure time: in both kinetic and two-point assay, it is the whole
measuring time. Please refer to reagent insert sheets for the setting. In
other assays, it is the period to get the end or stable point, 2 seconds is
recommended.
3.4.4 Temperature: there are four selections i.e. (1) room temperature, (2)
25 C (3) 30 C and (4) 37 C. Normally, choose 37 C.
3.4.5 Factors: in kinetic, Two-point, End-point, Double Wavelength and
Sample Blank assay, Factor will be available.
3.4.6 Drain mode: means the flow cell draining mode. Draining will take
in 500l of air after each sampling to drain the flow cell and decrease
cross contamination. Make bubble will absorb air automatically to
divide each sample intake to minimize cross contamination. However,
these two modes are prone to catching bubbles in the flow cell.
You may select No draining, which means that the analyzer will not
take in air after sampling when you press the test button.
3.4.7 Linear range: If the reactive components of samples is too high an
incorrect concentration value will result. However, after imputing Linear
range and this kind of error occurs the analyzer will distinguish it
automatically and remind users by displaying Linear Error. Also the
resulting value will be followed by the symbol E for error.
Please refer to reagent specifications or consult reagent providers for
more specified data.
3.4.8 Valid blank Input the valid blank value according to reagent
specifications. Its unit is mAbs, e.g. if reagent blank value specified is
not less than 0.8A then you should input it as [>800]. During the test, if
the valid blank value result from the testing does not accord with the
condition, the analyzer will display an error to indicate that the reagent
is unavailable or invalid and must be changed.
TIP: LINEAR RANGE & VALID BLANK RANGE MAY CAUSE WRONG
WARNINGS, BUT IT WILL NOT INFLUENCE ACCURACY OF THE
TESTING.
Figure 9
Figure 10
3.5 Quality Control Management: when the item needs to make quality control, it
should be done as follows.
Figure 11
3.5.1 Enter the selected item of submenu Edit item name (see figure 8)
from main menu. Press quality control to enter the items quality
control management interface. It will be displayed as Figure 11.
3.5.2 Press "Parameter ", "ID", QC X, SD, etc, input parameters by press
arrow key. Then Press Yes. This items quality control editing will be
finished. If users want to compile other items quality control, the above
operation should be repeated. The interface will display the last Q.C.
item edited.
3.5.3 Press Return back to the main menu. Test Q.C. serum in normal test
interface by pressing QC test. Test twice is recommended, so as to
reduce cross contamination.
3.5.4 If users want to review the reserved QC item, you should enter:
Quality Control from the main menu. Then in the submenu,
press Item, and lastly use arrow key up & Down to select the
reserved item. And press Yes to review.
3.5.5 In the QC management interface you can review a fixed days QC result
by pressing Date (01) and selecting the definite day. With arrow key
up and Down
3.5.6 Pressing print will print quality control graph and all its results, e.g. ,
SD, CV value etc.
3.5.7 Press Del. then press Yes will cause all the present items reserved
data to be deleted.
Liver function
Kidney function & Ions
Glucose & Blood fat
Cardiac muscle enzyme range
& others
Self-defined items
Return
Figure 12
4.2 According to what you want to test, select and press it; it will display the
submenu; e.g. Liver function, (See Figure 13).
GPT/ALT TP
GOT/AST Al b
ACP FB
ALP NH3
T-Bil -GT
D-Bil TTT
CHE Return
Figure 13
4.3 Then press testing item, e.g. ALT/GPT, it will display testing interface (See
figure 14)
Figure 14
4.3.1 Blank test : is highlighted when entering testing interface. After blank
test, it will change to Sample test high light. Recommend to repeat
Blank test in order to reduce cross-contamination.
4.3.2 Standard test: highlight Test standard 1 to calibrate. Recommend
to repeat Test standard 1 in order to reduce cross-contamination.
Press Yes to save Factor. In single standard test, you can only test
Test standard 1. In multiple standard test, please press Test
standard 1 twice, the screen will display Test standard 2, Test
standard 3by turn. Recommend to repeat test for each standard
sample.
4.3.3 Test sample: highlight Test sample to test sample. The Sample ID
will be increased by 1 automatically for every one more test.
4.3.4 The modification of Sample ID (001): highlight Sample ID (001),
modify the value by arrow key to make it accordant with a patient ID.
Press Yes to save modification.
4.3.5 QC test: highlight QC Test to test relative QC serum. Recommend to
repeat QC test in order to reduce cross-contamination. The results will be
displayed on LCD and automatically stored in QC database.
4.3.6.4 Print: press to print out the initial absorbance and reaction
curve simultaneously in kinetic method and two-point, or
only print reaction curve in other methods.
4.3.6.5 When blank absorbance value is out of the preset value, LCD
will show Blank value out of range. This maybe because you
do not enter a number. In this case, please check and input
proper valid blank absorbance value on the Edit item name
interface (see 3.4.8 of Chapter 3). It can also cause by reagent
deteriorated, light filter mAbs inaccurate (see 6.2 of Chapter 6),
or light path abnormal (e.g. by the contaminative flow cell or by
the lamp ageing). In these cases, the analyzer will not stop. But,
please check and correct the problem on time.
4.3.6.6 When results are out of the preset linear range, the analyzer
will show Out of linear range. In this case, please make sure
you have input the correct Linear range (see also 3.4.7 of
Chapter 3) according to reagent inserts. If the Linear range is
correct, you need to dilute the sample with 2 times or 5 times.
Press 2x or 5x, the analyzer will give the results with
multiplying 2 or 5. Press Yes to print results. e.g. diluting the
sample with 50 times means that you should press 5x two
times and 2x one time: x5x5x2 = 50. Pay attention to the
patient ID, if the sample needs to be re-run. Itd better set back
as previous ID in order not to cause confusion.
4.3.7 Sapphire 120 Auto Analyzer can display reaction curve which can be
used for judging the quality of the reaction process. In kinetic and
two-point method, reaction section range and direction of reactive
curve are adjusted automatically.
4.3.8 y = ax + b: improve results accuracy.
a. Test QC serum several times, and calculate the actual mean value .
b. The QC serum assayed value X divided by the actual mean value ;
coefficient factor a = Assayed x/ actual mean value .
c. On the interface Edit item name select and enter Standard &cal.
Press cal see: y = a(1) x + b (0). The previous value a(1) multiplied
by the coefficient factor a get the new coefficient value.
d. You can also select and modify Factor in Edit item name interface
with coefficient multiplied by the existing factor inside a( ). Replace
the existing factor by the new one and press Save.
e. In some cases, there is an equal difference value between Assayed
and Actual QC values in different QC level. The total of the equal
difference value and the value inside b( ) will be new value to be enter
in b( ). Press Save, the modification also can be finished in this way.
4.3.9 Press Return to perform a new test.
4.3.10 Find out database to print the com-report.
4.4.1 When you have to use double reagents and there is only one reagent,
you may use distill water instead of R1 to test sample blank. But in this
way there may be disadvantage influence for the results accuracy.
4.4.2 Prepare test tubes respectively as following: (See figure 15)
Figure 15
CAUTION:
1. BLANK TEST SHOULD BE RUN BEFORE STANDARD TEST.
2. WHEN TESTING AN ITEM FIRST TIME IN A DAY, BLANK TEST
SHOULD BE RUN FIRST. STANDARD TEST COULD DEPEND ON
THE REAGENT SPECIFICATION.
3. REAGENT BLANK 1 (RI) SHOULD BE RUN BEFORE REAGENT BLANK
2 (RI + RII). HOWEVER, THERE IS NO SEQUENCE DEMAND IN
STANDARD TEST AND SAMPLE TEST.
4. NO.1 IS FOR THE FIRST TIME TEST; NO.2 IS FOR THE SECOND
TIME TEST. WHEN SAMPLE TEST, THE SAMPLE ID WILL BE
INCREASED BY 1 AUTOMATICALLY AFTER THE SECOND TEST.
5. THE SAMPLE BLANK METHOD IS ONLY APPLICABLE TO END-
POINT OF SINGLE STANDARD.
Result database
Date: 2001.06.06
ID Name Result Unit H/L Range
001P 1 0 IU 0.00 -0.00
002P 1 423.5 IU E0.00 -0.00
003P 1 425.6 IU E0.00 -0.00
004P 1 413.2 IU E0.00 -0.00
Figure 16
5.2 Press Date, select dates by arrow key up and down. Then press Yes, the
data will show in the data section in the sequence of sample ID. Move the cursor
by arrow key to review the data. Press modify, the selected result data will be
highlighted. Modify it by the up and down arrow key. Press Yes to save.
Press Del. to delete the selected data.
5.3 Press com-report, the data will be sorted by sample ID. Select sapmle by up
and down arrow key, press Print single to print the selected sample
combined report. Press Print Continuous, it will print all patients combined
report of the day behind cursor. When the results are higher than maximum of
expected value, it will print sign H. On the contrast, print sign L. When the
result is out of the linear range, print sign E.
5.4 Press Name, the data will be sorted by item name. Select the item name by
up and down arrow key. Press Yes to re-sort. Press Print single to print
the selected item report. Press Print Continuous, it will print all item report of
the day behind cursor.
5.5 Sapphire 120 Auto Analyzer will transfer all printing data to host Pc through RS-
232 port while printing.
Maintenance
Return
Figure 17
6.2 Press Light filter Lens & Abs to check the light filters and the absorbance.
Enter below interface: ( See figure 18)
Filter Filter
340nm 00. mAbs 578nm 0.22 mAbs
405nm -08.19 mAbs 630nm 014.0 mAbs
510nm 26.7 mAbs F1 00.00 mAbs
546nm 7.68 mAbs F2 00.00 mAbs
Figure 18
6.2.1 Follow the note on the screen, aspirate distill water into the flow cell fully
by pressing test button. Press each filter, the analyzer will check the
light filters position status, and display the dynamic Abs. which will be
stored as distilled water blank Abs. of filter. This blank Abs. value will be
basic comparative benchmark value for reagent blank absorbance value
and sample absorbance value. It will be deducted automatically in
actual computing the reagent black absorbance value and sample
absorbance value. Please wait until one filter dynamic absorbance is
stable before transfer to the next one. Press Yes and Save to store
the blank value. Otherwise, it still keeps the previous data.
6.2.2 Press Yes, the analyzer will automatically judge whether the position of
photometer system and filters are normal or not. Then display relative
notice, e.g. Clean the flow cell, Exchange the lamb, Check **nm light
filter etc. but these notices are only for reference. The operator should
judge by himself according to the observational data and phenomena.
Figure 19
6.3.1 Press Open and Standby respectively, see whether the light source
is normal or not.
6.3.2 Press Lamp standby timing to set up the interval time of lamp
standby. If there is no operation during this interval, the lamp will be in
standby automatically. The lamp will back to fully brightness when
pressing test button or any key on LCD. Lamp will be stable for test in
very soon time (about 1 minute) since the analyzer is already for warm-
up. This function will extend the life of lamp.
6.3.3 Press Auto test, it will print out self test symbols. Press Paper
advancing, printer paper will be one step ahead.
Pump management
Figure 20
6.4.1 Press test button to run Aspirate, Reverse, Cycle and Stop
respectively. Check whether the pump works ok or not. LCD will display
Aspirate 100ul pump: xxx steps in the mean time.
6.4.2 The peristaltic pump needs calibration along with its ageing. the method
as the following:
Press Calibration LCD will display prepare 4 vessels each with 5 ml
H2O, following the instruction. Follow the instructions and put the first
5ml distill water under Aspirating tube.
Press test button to start aspirating, and again for stop. Repeat four
times. The LCD will respectively display the revolving steps which are
input automatically of the 100ul distill water inhaled. After finishing
these four times step tests, it will calculate the average value of the
revolving 5 steps for 100ul distill water. If the operator thinks that this
calibration is successful, please press Yes to replace the data inside
aspirate 100ul pump: xxx steps. Otherwise, press Retry to re-
calibrate.
6.4.3 Press Return to go back to the previous interface Maintenance and
Management.
Figure 21
2002 Y 01 M 13 D
23 H 21 M 35 S
Figure 22
6.6.1 The page displays current date and time. Press Year, Month, Day,
Hour, Minute and Second to modify with arrow key. Press Yes to save.
6.6.2 Press Return before Yes, the Date &time will be back to the
previous time.
Figure 23
7.3.3 Loosen the top screw of the lamp. Take out the used lamp.
7.3.4 Clean the new lamp and fit it into the hole as the original position. Pay
attention to the Lead which should be in position. Tighten the screw,
and connect the plug. Now it can be used again and it is no need to
adjust the lamp position.
7.3.5 Re-gain distill water blank Abs. in Light filter Lens & Abs interface.
Please refer to 6.2 of Chapter 6.
Figure 24
7.5.1 Take out a peristaltic pump pipe from accessories or buy a new one
from the manufacturer.
7.5.2 Draw the pipe to the left and take out the two connectors from the
concave gaps.
7.5.3 Push the pump body rightward to create a chink between the pump
body and the pump wheel and wind the used pipe out from the chink.
7.5.4 Disconnect the used pipe at the two connectors.
7.5.5 Insert the two connectors in the new pipe be sure that the new pipe
should be rooted until it reach the inserted ends of the two connectors,
and that lubricators can not be used for this connection.
7.5.6 Install the fixed pipe on the pump body at the wheel and concave gaps
places by the reverse way of disassembling it. Press leftward the pump
body so as to tighten the new pipe. Otherwise it may not inhale liquids.
7.5.7 Re-calibrate the pump in Pump management interface. Please refer
to 6.4 of Chapter 6.
Figure 25
7.6.1 Loosen the holding screw on the right side, and pull out the flow cell
upward.
7.6.2 Buy a new one from the manufacturer. Clean quartz windows with
anhydrous alcohol. Please note the flow cell installation direction: Liquid
exit (the connector leading to the peristaltic pump) should be in front
position, and the Aspiration tube (the other connector for inhaling liquid)
in back position.
7.6.3 Fix the new flow cell and press it until it reach bottom. While your left
hand presses it, your right hand should tighten the holding screw.
7.6.4 Run Cycle rinse with cleaning liquid, then wash with distilled water.
7.6.5 Re-gain distill water blank Abs. in Light filter Lens & Abs interface.
Please refer to 6.2 of Chapter 6.
7.7.3 Fix a new Aspiration tube into the sucking hole tightly, so as not to
cause bubbles.
7.7.4 Insert the Aspiration tube slowly. A little lubricator (cleaning liquid or
dishwashing liquid mixed by water) is recommended. Be careful not to
bend the Aspiration tube.
7.7.5 Install the flow cell as 7.6 of Chapter 7.
7.7.6 Continuous aspirate distilled water and observe if there is any bubble in
the Liquid exit tube. If bubbles are found, it could be because tubing is
not well connected, or the flow cell leak. Please cheek or re-install the
flow cell.
Not suck in liquids Bad installation of pump tube z Check and install the
and inaccurate z The tubing or flow cell is pump tube properly
sucking volume blocked up z Use of reverse or
z No slacking and loosing injector to unblock the
the pump tube in a long tubing, or replace the
unworked time, leading to blocked tubing or even
stickiness flow cell.
z Ageing pump tube z Take out the pump
z Sucking pace modified by tube to unclog the
a mistake. sticking place by hands
to press it or replace
the pump tube.
z Check the pump paces
on the interface of
pump management to
make sure the pace
ranged between 200-
400 paces otherwise,
please readjust the
pump paces.
No words &unclear Not adjust brightness Adjust the brightness
words on LCD. adjuster
Zero & inaccurate z Not input standard value or z Test blank value and
result value factor standard solution value
z Not press yes key after again. It is better to do
testing standard liquid more tests of them; and
press yes key to save
the factors
z Adjust reagents
parameters according
to specifications.
Blank value out of The valid blank value is z According to invalid
range appears; incorrect; value in reagent
and the data is The reagent expires; specifications, modify
inaccurate Zero point is changed valid blank value
z Test blank value again
by mixing the new
reagent
z Adjust water zero point
by entering the
interface of examine
light filter &
absorbance
Higher or lower Need modification or testing Please modify it as
testing results standard liquid again. Chapter4.37 or test
standard solution again.