URIT-880 Standard Operation Process

Hospital Version: V2.
07
Department URIT-880 Standard Operation Process Exec Date: Jan. 30th, 2015
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Catalogue
Catalogue.................................................................................................................................................................................I
1. Preface................................................................................................................................................................................... 1
2. Safety Precautions..................................................................................................................................................................1
3. Working Process.....................................................................................................................................................................3
4. Start-up...................................................................................................................................................................................4
4.1 Check before Start-up...................................................................................................................................................4
4.2 Switch on the Power.....................................................................................................................................................4
4.3 Rinse after Start-up.......................................................................................................................................................6
4.4Standby and Preheating.................................................................................................................................................6
5. A/D Calibration......................................................................................................................................................................7
6. Measure Parameters Setting of Item......................................................................................................................................9
6.1 Set the Measuring Parameters of Item..........................................................................................................................9
6.2 Explanation with the Setting of Item Parameters.........................................................................................................9
7. Add, Delete and Reset the Measurement Item.....................................................................................................................12
7.1 Add Measurement Item..............................................................................................................................................12
7.2 Delete Measurement Item..........................................................................................................................................12
7.3 Reset Measurement Item............................................................................................................................................12
8. Preparation before Measurement.........................................................................................................................................13
8.1 Preparation before Measurement................................................................................................................................13
8.2 Standard Operation of Collecting Serum before Measurement..................................................................................13
8.3 Standard Operation of Using Reagent........................................................................................................................13
8.4 Confecting the Mixed Solution of Reagent and Sample.............................................................................................14
9. Analytical Measurement...................................................................................................................................................... 15
9.1 Measurement Item......................................................................................................................................................15
9.2 Blank Measure............................................................................................................................................................15
9.3 Calibrate Measure...................................................................................................................................................... 15
9.4 QC Measure............................................................................................................................................................... 16
9.5 Sample Measure.........................................................................................................................................................16
10. Edit and Print Results.........................................................................................................................................................17
10.1 Query the Measurement Result................................................................................................................................17
10.2 Edit the Patient’s Information...................................................................................................................................18
10.3 Query the Laboratory Sheet......................................................................................................................................18
10.4 Modify the Results...................................................................................................................................................19
10.5 Print the Laboratory Sheet........................................................................................................................................19
10.6 Export and Import Data............................................................................................................................................19
11. QC Data..............................................................................................................................................................................21
12. Reagent, Sample and Waste...............................................................................................................................................23
12.1 Biochemical Reagent................................................................................................................................................23
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Hospital Version: V2.07
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12.2 Detergent..................................................................................................................................................................23
12.3 Precautions...............................................................................................................................................................23
13. Shutdown and Storage.......................................................................................................................................................24
13.1 The Process of Shutdown.........................................................................................................................................24
13.2 Storage......................................................................................................................................................................24
14. Instrument Maintenance.....................................................................................................................................................25
14.1 Preparation before Maintenance...............................................................................................................................25
14.2 Maintenance Record.................................................................................................................................................25
14.3 Daily Maintenance...................................................................................................................................................25
14.4 Weekly Maintenance................................................................................................................................................25
14.5 Monthly Maintenance...............................................................................................................................................26
14.6 Nonscheduled Maintenance......................................................................................................................................26
14.6.1 The Cleanness of Cuvette..............................................................................................................................26
14.6.2 Maintenance of Printer..................................................................................................................................28
14.6.3 Replace the Sample Tube..............................................................................................................................29
14.6.4 Replace the Tube of Peristaltic Pump............................................................................................................30
14.6.5 Replace the Fuse Protector............................................................................................................................31
Appendix 1: List of Main Replaceable Components........................................................................................................32
Appendix 2: The Factory Item Sequence and the Full Name of Test Code......................................................................33
Appendix 3: Table 1 of Maintenance Record...................................................................................................................34
Appendix 4: Table 2 of Maintenance Record...................................................................................................................36
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1. Preface
This SOP file is mainly drawn up based on the Operating Manual of URIT-880 Semi-auto Chemistry Analyzer. Only
operating the analyzer and managing sample correctly and using reliable reagent can obtain correct and reliable results.
This file provides users with a standard operation process about how to operate URIT-880 Semi-auto Chemistry Analyzer
(hereinafter referred to as analyzer) correctly.
URIT reserves the right to renovate the relevant contents in this SOP file without separate notice.
2. Safety Precautions
(1) Breakage and Flammability

Please comply with the following precautions to prevent breakage and fire.
WARNING
1) Install strictly in the installing environment as instructed by this manual correctly.
2) If relocation is necessary, contact your local distributor or URIT firstly.
(2) Electric Shock

Please comply with the following precautions to prevent electric shock.
WARNING
1) DO NOT pull or insert the joints on any charged port, such as the power supply port, the bi-directional
data link port, etc.
2) It is forbidden to place this analyzer beside high-power equipment or the instrument which is flammable
or explosive to avoid fire disaster, explosion and instable test results.
3) Users other than professional person must not open the analyzer to do repair and maintenance.
(3) Personnel Infection

Please comply with the following precautions to avoid getting hurt when using this analyzer.
NOTE
1) Be sure to wear protective devices, including mouth-muffle, gloves etc. when you are operating the
moving components or managing medical waste, to avoid scratch or infection caused by nonstandard
operation.
2) Before replacing the lamb, please turn off the power supply and do not operate until it cools down to
avoid scald.
(4) Personal Eye-protection

Please comply with the following precautions to avoid personal eye-protection.
NOTE
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DO NOT straight look at the light source when this analyzer is in motion (the status lamp is on).
(5) Biohazard Precautions

Please comply with the following precautions to prevent biohazard.
BIOHAZARD
1) Incorrect conduction of samples may cause infection. DO NOT directly touch the sample, quality-control
liquid, calibration liquid, mixed solution and waste solution. Be sure to wear protective gloves, working
clothes in case of infection or even goggles if necessary. If the sample splashes to the skin accidentally,
please treat it immediately according to the users’ working standards and consult a doctor.
2) Some substances contained in QC solution, standard solution and waste solution are regulated by Pollution
Control Regulations and Discharge Standards. They must be disposed according to the local discharge
standard regulations.
3. Working Process
Start-up
Start-up
A/D calibration
A/D calibration
Test parameters setting (check,

Test parameters setting (check,
type-in, and set)
type-in, and set)
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Preparation before test (serum,

Preparation before test (serum,
reagent, confect and incubate)
reagent, confect and incubate)
Analytical test (calibration, QC

Analytical test (calibration, QC
and sample)
and sample)
Print the results

Print the results
Instrument maintenance
Instrument maintenance
Shutdown
Shutdown
4. Start-up
4.1 Check before Start-up

Check the following items before you switching on the power:
(1) Prepare sufficient deionized water.
(2) Check if the power supply is 100-120V or 200-240V~.
(3) Check if the power cord is plugged into the socket.
(4) Check if the waste solution bottle is full and if the waste solution tube is inserted into the waste solution bottle.
(5) Checking the print paper: check if the loaded print paper is enough for the needs of intraday tests. If it is insufficient,
users should prepare for adding it.
4.2 Switch on the Power

(1) Turn on the power switch on the side panel of this analyzer. The instrument will do self-inspection. See as the Figure 1.
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Figure 1 Interface of Self-inspection
(2) Login software: Selecting the User Name, entering the Password, and then clicking the Login button, then users can
enter the interface of Main Menu.
Figure 2 Login Interface of Software
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Figure 3 Interface of Main Menu
4.3 Rinse after Start-up

(1) Enter the interface of measuring absorbance and execute the rinse function in the interface. Firstly, this analyzer should
imbibe ethyl alcohol into the tubing and cuvette for three times to do deep clean.
(2) And then imbibe deionized water into the tubing and cuvette for 5 to 10 times to clean them.
Figure 4 Interface of Absorbance Measure Running

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4.4Standby and Preheating

After start-up and rinse of this analyzer, return to the interface of Main Menu and make this analyzer entered the status of
standby for about 30 minutes.
NOTE
To guarantee the accuracy and stability of test results, users should insure the time of preheating and the
measuring temperature has met the specified requirements before doing tests.
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5. A/D Calibration
(1) Rinse this analyzer with deionized water for 5 times to insure the cuvette is full with water.
(2) Click the Settings button in the interface of Main Menu to enter the interface of setting.
(3) Click the Water blank A/D button to enter the interface of Water blank A/D. Click Edit button, and then users can
correct the A/D value.
Figure 5 Interface (1) of Water blank A/D

(4) After imbibing deionized water, click the Measure button, system will calibrate the A/D value of water blank of
different wavelengths.
(5) After finishing calibration, click the Apply button, system will save the calibration result and take this result as the
reference value of all the later measurement.
Figure 6 Interface (2) of Water blank A/D

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NOTE
1) The A/D value of wavelength which is between 300nm and 800nm is 3200 to 3900.
2) To guarantee the stability of calibration data, users should exclude bubbles in the cuvette and the situation
that the external power supply is instable.
(6) Click the Back button to return to the interface of Main Menu.
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6. Measure Parameters Setting of Item

System allows users to deploy the item parameters. The default item parameters can only apply to the reagent of URIT.
When operate with reagents of other company, users must set the item parameters as the instruction of reagent and lab
requirements. The sequence of biochemical items and the comparison table of names can be consulted in the Appendix 1.
When using this analyzer for the first time, users must insure the following basic parameters: Test Code, Assay Mode, 1st
WL and 2nd WL, Unit of result, Blank Type, Blank Abs., measuring Temperature, Sampling Volume, Delay Time,
Measure Time, Concentration of calibration sample and factor, the maximum and minimum Usual Value, etc. In the
routine usage, users can set the parameters as required.
NOTE
When the parameters are set incomplete or unreasonable, system will remind that some setting is false and
system can’t do measurement until the parameters are set correctly.
6.1 Set the Measuring Parameters of Item

(1) Click the Measure button in the Main Menu and select the item which is to set parameters.
(2) Click the Edit button to enter the interface for editing the item parameters. And then set the parameters of the item as
the instruction of reagent, including Test Code, Assay Mode, 1st WL, 2nd WL, Blank Type, Blank Abs.,
Temperature, Sampling Volume, Delay Time, Measure Time, Concentration of calibration sample and factor,
Usual Value, etc.
6.2 Explanation with the Setting of Item Parameters

Basic 1
(1) Test Code: The name of item. User can input the English name or Chinese name of item. Users can type in the item
name via the soft keyboard.
(2) Assay Mode: The measure method used to calculate test result in measuring items, including method of Endpoint,
Kinetic, 2-point Kinetic and Dual WL.
(3) 1st WL: It is used to measure the light absorption intensity of the analyte. Please set as the instruction of reagent. Its
options include 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 700nm. The 1st WL can’t be null.
(4) 2nd WL: When testing some sample, the 2nd WL is set for eliminating the measure interference on the 1st WL caused
by other interfering substance, such as the flicker and excursion of light source, the scratch of cuvette, etc. In the Dual
WL method, the selectable options include 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm,700nm. The 2nd
WL can’t be the same as the 1st WL.
(5) Blank Type: It includes the blank of water, reagent and sample.
(6) Blank Abs.: The absorbance of blank solution. It is used to calculate the calibration coefficient. (It only applies to the
Endpoint item.)
(7) Temperature: The temperature of cuvette can be set as 25℃,30℃,37℃or room temperature. The system default is
37℃.
Basic 2
(1) Unit: The unit of measure result. Users can select it according to the reagent instruction.
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(2) Sampling Volume: The volume need to add into the reaction solution in measure. Its unit is μL. It can’t be too small, or
the measure result will be incorrect.
(3) Delay Time: The time from finishing imbibition to start the measure. (Set it as the reagent instruction.)
(4) Measure Time: The time of reading the absorbance which involves in calculating result. Set it as the reagent
instruction.
(5) Print or not: When selecting print, it will print the current measure result. Otherwise, it will not print.
(6) Decimal: The decimal digits of measure result can be 0 to 4. Please set as the reagent instruction.
Basic 3
(1) Usual value: The maximum value is the highest concentration of normal sample. The minimum value is the lowest
concentration of normal sample. If the measure result exceeds the reference range, the patient may be in bad health
condition. When the practical measure result is out of the reference range, the value exceeds the maximum value will be
marked by ↑, and the value exceeds the minimum value will be marked by↓.
①Reference：The minimum reference value and maximum reference value.
②Linear Range：Linear range of reagent.
(2) Substrate Exhaust: In the measurement of Kinetic method, the concentration of part of samples is quite high, and then
the substrate exhaust will arise.
Substrate Exhaust: It only applies to items measured by Kinetic method.
□ Enable: The function of selecting whether to use or not. (Not use-□, Use-■.)
Reaction Direction: Positive reaction or negative reaction.
Threshold: The minimum reference value and maximum reference value.
Calibrate 1
（1）Calibration Method: The calibration method(One point linear, Two point linear, Multi-point linear, Polygon method,
Logistic-Log 4P, Logistic-Log 5P, Spline)
（2）Regulatory A/Regulatory B：After the test, the system automatically uses the Regulatory factor to correct the test
result according to the following formula: Y=AX+B.
Among them, X is the result before correction, Y is the result after correction, A is the correction slope, and B is the
correction intercept.
Calibrate 2
(1) Concentration: The concentration of standard solution which is used to measure the K value.
(2) Abs: Absorbance of the measurement result.
(3) Factor: It is the standard factor (K value). The calibration factor can be set only when the calibration method is one
point linear.
The relationship between the concentration of standard solution and the calibrate coefficient is as following:
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7. Add, Delete and Reset the Measurement Item
7.1 Add Measurement Item

(1) Click the Measure button in the Main Menu, and then click Add button. The interface for setting the parameters of
new item will appear.
(2) Click the Edit button and input the parameters of new item, such as Test Code, Assay Mode, 1st WL, 2nd WL,
Temperature etc.
(3) Click Apply button to save the current parameters.
(4) Click Back button to return to the previous menu.
7.2 Delete Measurement Item

Click the Measure button in the Main Menu, and lightly touch the item that you want to delete, click Edit button, and then
click Delete button to delete the item.
7.3 Reset Measurement Item

When users don’t want the current item parameters or want to recover the factory item parameters, users can execute the
following operations:
Click Measure button in the Main Menu, and then click the Default button. System will recover the factory item
parameters and at the same time it will eliminate all the QC data in this analyzer’s memory.
WARNING
When resetting item parameters, system will eliminate all the QC data in this analyzer’s memory. So users
should execute it prudently.
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8. Preparation before Measurement
8.1 Preparation before Measurement

To get accurate measure results, users should execute the following procedures before measurement:
(1) Prepare sufficient deionized water for rinsing the cuvette and tubing.
(2) Enter the interface of Absorbance Measure or the interface of General Measure, and then click the Rinse button.
After pumping the ethanol into the cuvette and tubing, and socking for 5 minutes, use the deionized water to rinse the
tubing for 3 to 5 times.
(3) Preheat this analyzer for 30 minutes, insure the light source is stable and the temperature reaches the presupposed
value. Rinse this analyzer with deionized water for 5 times again, to insure the cuvette and tubing are clean and without
slot.
8.2 Standard Operation of Collecting Serum before Measurement

(1) When collecting the serum, users should avoid collecting the serum with fibrous protein. Otherwise, it will influence
the accuracy of measure result.
(2) Users should avoid producing air bubbles when collecting serum and reagent. Otherwise, it will influence the accuracy
and repeatability of measure results.
8.3 Standard Operation of Using Reagent

(1) Users mustn’t use the reagent as soon as taking it out from the refrigerating box. Users should place it quietly for 15
minutes and shake it up before using it to confect and measure.
(2) The confecting volume of reagent should strictly accord with the Inspection Operation Rules.
(3) Operate strictly according with the requirement about the incubation time and incubation temperature of reagent
measurement.
Note:
The item whose temperature is set 37 degrees centigrade in the item measurement mustn’t be measured until the
temperature of cuvette reaches 37 degrees centigrade.
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8.4 Confecting the Mixed Solution of Reagent and Sample

The appliance and consumable items used in confecting the mixed solution of reagent and sample: pipettors of 1000ul,
200ul, 20ul, and 10ul, several suction nozzles for pipettors of 1000ul, 200ul, 20ul, and 10ul, a tube rack and several 5ml
disposable soft plastic tubes.
Figure 7 Tools for Measurement

Prepare sufficient reagent and sample solution in advance based on the time of use. And then confect them in proportion.
The items measured by Endpoint method should be measured after finishing incubation which should accord with the
requirements in the reagent instruction. While the items measured by Kinetic method can be measured directly.
Note:
(1) The mixed solution of reagent and sample should be shaken up fully. Block off the mouth of soft plastic tube
with rubber plug to insure the solution won’t outflow and shake it up vertically for 5 to 6 times.
(2) The items measured by Endpoint method should be incubated in the incubator. As requirements in the
instruction, it can be measured after the full reaction of solution at the end of incubation time.
(3) The items measured by Kinetic method can be measured directly after fully mixing.
9. Analytical Measurement
9.1 Measurement Item

(1) Prepare the sample, calibration material, QC material and blank solution.
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(2) Click the Measure button in the Main Menu, to enter the interface of General Measure.
(3) Select the item that you want to measure, to enter the interface of General Measure of this item.
(4) According to the time of use, confect sufficient mixed solution of reagent and sample in advance in proportion. (Refer
to the Chapter 8.4 for the detailed procedures.)
(5) Click the Run button in the interface of General Measure of sample to start the measurement.
NOTE
For some items, users should incubate the mixed solution in the incubator or water bath case as the reagent
instruction before measure it in this analyzer.
9.2 Blank Measure

(1) System will prompt to pump in blank solution in the Phase column. Users need to put the measuring blank solution
under the sample tube and press the Start key, and then analyzer will start to pump in blank solution. The measure
process and blank result will be showed on the window.
(2) The blank solution includes: reagent, sample and deionized water. Please prepare related blank solution according to
blank type of the item.
(3) When the blank type is deionized water (i.e. deionized water blank), system will prompt whether to remeasure blank or
not, users can select it as the lab requirements.
NOTE
Users confirm the blank type according to the practical situation of sample. It is suggested that users should
do sample blank to the samples of hemolysis, jaundice and lipoidemia, etc.
9.3 Calibrate Measure

(1) System will prompt to pump in calibration material in the Phase column. Users need to put the measuring calibration
material under the sample tube and press the Start key, and then analyzer will start to pump in calibration material. The
measure process and calibrate coefficient will be showed on the window.
(2) If the calibrate coefficient has been set in the item parameters, system will automatically skip the calibration
measurement.
9.4 QC Measure
(1) Click the QC button, system will prompt to pump in QC material in the Phase column. Users need to put the
measuring QC material under the sample tube and press the Start key, and then analyzer will start to pump in QC
material.
(2) After completing the QC measurement, system will prompt to select the lot of this QC material. Users can select the
existing QC lots in the drop-down box and input new QC lots by click the Add button. System will save this QC result
to the database of QC results which are used for QC analysis.
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9.5 Sample Measure

(1) System will prompt to pump in sample in the Phase column. Users need to put the measuring sample under the sample
tube and press the Start key, and then analyzer will start to pump in sample. And then complete measurement of this
item of other samples in turn as these procedures.
(2) After completing measurement, system will show the results. At the same time, users can also review the wavelength,
temperature, assay mode and calibrate coefficient etc. of this item in this interface.
(3) After finishing measuring all the samples of this item, prepare deionized water under the sample tube. Click Rinse
button to rinse the cuvette and tubing for 3 to 5 times. Before measuring the next item, users should exclude reagent
interference and cross contamination. (Use ethanol to rinse if necessary.)
Note:
(1) Use deionized water to rinse. And don’t use strong alkali or acid detergent to rinse.
(2) Store the reagent in the refrigerating box as the requirements of storage.
(3) Check whether the working platform is with blot or not. If yes, wipe it off with a clean soft cloth.
(4) Manage the useless serum and consumable items according to relevant regulations.
WARNING
When switching the measure item or after finishing measuring high-concentration sample, users must rinse
the cuvette and tubing. Otherwise, it may cause unreliable measure results.
10. Edit and Print Results
10.1 Query the Measurement Result

After finishing the analysis, click the Results icon in the Main Menu to enter the interface of Measure Results. Screen will
show the latest measure results based on the measurement time, including the Test Code, Sample ID, Measure Results, Unit,
and Prompt. Users can click the arrows of ↑ and ↓ to review more results. Users can execute the following functions in this
interface:
(1) Edit patients’ information.
(2) Review the laboratory sheets.
(3) Modify results.
(4) Print the laboratory sheets.
(5) Import or export the data.
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Figure 8 Measure Results

Empty: empty all the measure results.
Export: in the interface of Export, users can export and import data, including setting of routine measure, QC data, setting
of curve measure, record of measure result, laboratory sheets, and setting of user account and authority management.
Laboratory Sheets ： Enter the list of patients’ laboratory sheets, the screen will show the contents include sample ID,
patient Name, UUID and Gender. Users can search and print the results in this interface.
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10.2 Edit the Patient’s Information

Click Results button in the Main Menu➙ Laboratory Sheets, and then input the patients’ basic information after the
relevant sample ID , including Name, UUID, Gender, etc.
Figure 9 List of Laboratory Sheets
10.3 Query the Laboratory Sheet

Click Results in the Main Menu➙ Laboratory Sheets➙ Search to enter the interface of Laboratory Sheet Search, see
as the following figure. System provides two ways to search, Precise Search and Fuzzy Search. For precise search, users
can search by sample ID. For fuzzy search, users can search by name of patient, UUID, or date of measurement. After
selecting the type of search and inputting the search condition, click Start button, the screen will show all the results that
accord with the searching condition.
Figure 10 Searching the Laboratory Sheet
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10.4 Modify the Results

After completing measurement, if any measure result which is out of the reference range is found, users can edit or modify
this result. But users must insure the authority to do it before executing modification of results.
In the interface of Measure Results, users can directly edit the results which are to modify, and complete the modification.
10.5 Print the Laboratory Sheet

After completing the measurement, the laboratory sheets can be printed out by thermal printer or external printer.
Click Results in the Main Menu➙ Laboratory Sheets to enter the interface of Laboratory Sheets. Users can select to
print all the data or print the laboratory sheet of some patient by touching the specified sample result to enter the interface of
Laboratory Sheets and clicking the Print button.
Function keys:
Print: print this sample.
Details: search or edit the detailed information of sample, including sample ID, name of patient, gender and number of
measure items.
10.6 Export and Import Data

Users can realize the data migration which includes setting of item measurement, QC data, setting of curve measure, record
of measure results and laboratory sheets, user accounts and setting of authority management, etc. by mobile storage device
like SD card, USB, etc.
Select the
storage path
Figure 11 Interface of Export and Import

The procedures of importing and exporting data are as following:
Click Results➙ Export to enter the interface of Export and Import ➙ select the program (Export or Import) to perform
and select storage path➙ select the item you want by the shortcut key (Select All or Clear All) or touching the item you
want➙ click Start➙ system will execute the relevant program.
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11. QC Data
In the QC data interface, users can review the QC results and QC charts to judge if the item is out of control. Analyzer will
do mathematical statistics and calibration to the QC samples. Each item can save the QC data of at most 3 lots. And each lot
can at most save the QC data of the latest 3 months.
Click the QC in the Main Menu, to enter the interface to select QC item. Touching the item to measure, screen will show
the interface to select QC lot of this item. And in this interface, users can add and delete the QC lot, modify the name of QC
lot and review the QC data.
Function keys in the interface of QC Batches:
Empty: empty all QC lots of the current item.
Delete: delete the current QC lot.
Rename: rename the current QC lot.
Date: review the QC data of current QC lot. It indicates that there is no QC data when this button is gray.
Back: back to the previous menu.
Users can review QC lot by selecting items in its drop-down box. And then click Go to review the QC data. See as the
Figure 12. If the target value and SD value have been input, the QC curve will be calculated based on the input data.
Otherwise, system will draw the QC curve based on the mean value and SD value automatically calculated by this analyzer.
Figure 12 Interface of QC Data (ALT)

Function keys:
Delete: delete the current QC data.
Edit: click this button to input the target value and SD value of QC.
Chart: click this button to display the chart of the current QC data and this button will switch to Table button.
Back: click this button to back to the previous menu.
Click the Chart button to review the QC curve, see as the Figure 13:
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Figure 13 QC Curve
Parameter introduction:
Mean: the arithmetic mean value or the input target value of the current QC data. If the target value has been input, system
will preferentially display the target value.
SD: the standard deviation or the input SD value of the current QC data. If the SD value has been input, system will
preferentially display the SD value.
CV: the coefficient of variation of the current QC data.
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12. Reagent, Sample and Waste
12.1 Biochemical Reagent

(1) This analyzer allows users to set the parameters of biochemical reagent.
(2) Users should use the qualified reagent with registration certificate to do measurement.
(3) Read the reagent instruction carefully before using the reagent.
12.2 Detergent
Detergent is optional.
12.3 Precautions
(1) When carrying out test and daily maintenance, be sure to obey the operation regulations of lab or clinical examination,
and wear protective gloves, clothes and goggles to avoid contacting the sample.
(2) All clinic samples should be handled according to the established operation regulations of lab or clinical examination,
as they may carry potential infectious disease. Wear protective clothes, gloves and goggles. No smoking and eating in
working area. Do not blow or suck the tubes.
(3) Carefully dispose of the wastes as they may carry potential contaminations and cause biologic and chemical hazard.
Obey the local medical regulations to handle and dispose the waste solution.
(4) Store reagents according to the instructions offered by reagent supplier. User should establish keeping-and-using
system for reagents, to avoid using expired reagents, misuse and mistaking as food. Storage should keep away from
excessive hot or cold environment.
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13. Shutdown and Storage
13.1 The Process of Shutdown

Perform the following steps after daily work:
(1) Put reagents into icebox.
(2) Dispose of useless serum tubes according to relevant regulations.
(3) Rinse the analyzer with detergent for 5 times before turning it off.
(4) Wash analyzer with deionized water for 10 to 20 times.
(5) Insure the cuvette and tubing are filled with deionized water, and then cut off power supply.
(6) Empty the waste solution barrel.
(7) Clean the worktable with soft cloth.
BIOHAZARD
1) The discharge and disposal of reagent, QC solution, calibration solution, detergent, and waste solution are
regulated by certain standard provisions. Please observe the local regulations to discard waste and consult
the reagent supplier or distributor.
2) Wear protective clothes, gloves and goggles when you are disposing the waste solution.
13.2 Storage
(1) The packaged instrument should be stored in a breezy room with the temperature of 0 to 40 degrees centigrade,
atmospheric pressure of 63.2kPa to 106kPa, and relative humidity≤85%. Storage mixed with poison, injurant and
corrosive is forbidden.
(2) The cuvette and tubing should be filled with deionized water when it is not in use to prevent dirt from getting into and
influencing the precision of analyzer.
(3) Using the analyzer which is stored for over a year may fall short of precision. In this case, it is recommended to
recheck the analyzer before using it again.
NOTE
The recheck of analyzer must be performed by personnel authorized by URIT. If recheck is necessary, please
contact URIT.
14. Instrument Maintenance
14.1 Preparation before Maintenance

Users should prepare the following tools before performing maintenance:
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Tools Detergent
Sample tube Alkaline detergent
Peristalsis pipeline Anhydrous alcohol
Pincet Deionized water
Clean gauze
Clean cotton swab
Soft brush (for removing dust)
A set of hexagonal socket
14.2 Maintenance Record

After performing maintenance, please do maintenance records without delay (Table of Maintenance Record can be
consulted in the Appendix 3 and Appendix 4).
14.3 Daily Maintenance

(1) Wipe the liquid residue on the analyzer with a cloth soaking neutral detergent.
(2) Perform 5 to 10 times of rinse to the tubing with deionized water after turning on the analyzer.
(3) Perform 10 to 20 times of rinse to the tubing with deionized water before turning off the analyzer.
(4) Insure the cuvette and the tubing of analyzer are filled with clean deionized water when it is not in use.
(5) Empty the waste solution bottle.
BIOHAZARD
Put on protective gloves, clothes and even goggles when operating. If the waste gets to your skin, please dispose
it as the working standards of user and consult doctor.
14.4 Weekly Maintenance

(1) Clean the inner surface of waste solution bottle with deionized water. And soak the waste solution bottle with sanitizer
if necessary.
(2) Use the detergent with activating enzyme to soak the cuvette and head of sample tube for a certain time. (Note: DO
NOT soak for a long time if the detergent is strong corrosive.) And then rinse them for several times with deionized
water. It can aspirate the detergent to soak the cuvette by Rinse function.
(3) Perform the Rinse for 10 to 15 times with anhydrous alcohol.
(4) Insure the analyzer is power off. And then wipe the panel with clean gauze, and wipe with gauze soaking clean water or
sanitizer if necessary.
BIOHAZARD
1) Put on protective gloves, clothes and even goggles when operating. If the waste gets to your skin, please
dispose it as the working standards of user and consult doctor.
2) The gauze which is used to wipe the panel mustn’t be thrown at will. It should be disposed as the relevant
regulations.
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14.5 Monthly Maintenance

(1) The operations of monthly maintenance are the same as the Weekly Maintenance.
(2) Use the soft brush to remove the dust on the extractor fan.
(3) Check if the cuvette is with bubbles or foreign matters. If yes, please clean it.
14.6 Nonscheduled Maintenance
14.6.1 The Cleanness of Cuvette
(1) Background is on the Low Side

a. It may cause that the background is on the low side if the cuvette is contaminated or there is bubbles in it. Then users
should clean the cuvette with alcoholic solution.
b. Click Rinse button to empty and rinse the tubing.
c. Prepare 5mL alcoholic solution (alcohol: water=4:1) in a tube.
d. Insert the sample tube into the alcoholic solution, and click Rinse button. After soaking the analyzer for 10 seconds,
rinse the tubing with deionized water for about 10 to 20 seconds.
(2) Before Converting Test Item
When changing test item or after testing sample with high value, it is suggested that rinse the cuvette with deionized water
and each time of rinse should exceed 5 seconds. Users can also rinse the cuvette with exclusive detergent for biochemical
analyzer, and then rinse it with deionized water.
(3) Clean the Outer Surface of Cuvette
a. Empty the liquid in the cuvette and tubing.
b. Turn off the analyzer and disconnect the power line.
c. Press the cuvette with one hand, and take out the inlet tube and outlet tube from the cuvette by the other hand. Unscrew
the gland nut counter-clockwise and take out the cuvette from the hole.
Inlet metal tube
Nut
Outlet metal tube
Cuvette
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Figure 14 Structure of Light Path

d. If the outer optical surface of cuvette is contaminated, wipe it lightly with a clean soft cotton cloth soaking moderate
anhydrous alcohol.
Inlet Outlet
Figure 15 Clean the Outer Optical Surface of Cuvette

e. After cleaning the cuvette, put it back to the hole as the required direction and screw up the gland nut (just press the
cuvette and do not screw it hard). And then insert the relevant tubes into the inlet and outlet.
f. After cleaning the cuvette, restart the analyzer and check the parameters of light path. And then recalibrate the A/D
value. Please refer to the Chapter 14.6.6 for the detailed procedures.
14.6.2 Maintenance of Printer
Install the print paper of internal thermal printer complying with the following precautions:
(1) Insure the power supply of the analyzer is cut off before installing the print paper.
(2) Close the cover of printer after installing the print paper.
The installing procedures of print paper:
(1) Open the cover of printer.
(2) Shear the print paper to the following type.
(3) Put the print paper to the paper inlet and remain appropriate length of paper out of the cover. And then press down the
cover of printer.
Figure 16 Print Paper
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Figure 17 Installing the Print Paper
Maintain the printer:

(1) Please turn off the power of analyzer if it works abnormally.
(2) When replacing roll of paper, users must insure that there is no scraps of paper on the head of printer.
(3) Keep the route of printer clean and without dust.
NOTE: DO NOT disassembly the head of printer at will to insure the normal work of printer.
14.6.3 Replace the Sample Tube
During the using process, if the sample tube is clogged and can’t be unclogged, users can replace it with the one provided by
the analyzer. The sample tube is transparent materials, with external diameter of 1.5mm and length of 200mm. One end of
the sample tube is connected by a silicone tube with external diameter of 4mm and length of 30mm.
The method to replace the sample tube is as following:
(1) Empty the liquid path.
(2) Turn off the analyzer and disconnect the power line.
(3) Open the cover of optical window on the left side and pull up the tube on the metal inlet tube of cuvette.
(4) Draw out the old sample tube from the sample guide steel tube. Insert the end connected by a silicone tube of a new
sample tube into the sample guide steel tube of cuvette. And then make the sample tube traversed the sample guide
steel tube.
Sample Tube
Figure 18 Sample Tube
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Figure 19 Replacing the Sample Tube
14.6.4 Replace the Tube of Peristaltic Pump
If the aspirating volume decreases obviously or the analyzer doesn’t aspirate at all during the working process, observe if the
peristaltic pump at the back of analyzer is leaking. If yes, the tube of peristaltic pump may be broken because of abrasion,
and users should confirm and replace it. Analyzer has equipped with a pump line (beige), with external diameter of 3.2mm,
and length of about 115mm to 125mm.
The method to replace it is as following:
(1) Empty the liquid path.
(2) Turn off the analyzer and disconnect the power line.
(3) Open the toggle arm of the peristaltic pump at the back of the analyzer.
(4) Take out the tube of peristaltic pump and right-angle connector from the neck of peristaltic pump.
(5) Take down the tube of peristaltic pump from the right-angle connector.
(6) Insert one end of the new tube of peristaltic pump upon a right-angle connector, the other end traverses into the tube
installation mouth of the peristaltic pump and gets out from the other end of installation mouth after rolling the head of
peristaltic pump for a circle. And then connect it to the other right-angle connector.
(7) After connecting the right-angle connector, lightly pull the pump tube to make it fully fits the peristaltic pump. It
should not get the flaw of distortion, wrinkle, etc. and keep the length of the two ends of pump tube is basically equal.
Lightly pull the two ends of pump tube if necessary to make it smooth.
(8) Put the toggle arm of peristaltic pump back.
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Right-angle connector
Tube of peristaltic
Tube of peristaltic pump
pump
Toggle arm
Figure 20 Replacing the Tube of Peristaltic Pump

Note:
Since the tube of peristaltic pump directly contacts the dangerous materials, such as testing sample, reagent and
standard solution, etc., users must wear gloves before operating. If the solution gets onto your body, please wash it
with plenty water and do disinfection. Ask doctor for help if necessary.
14.6.5 Replace the Fuse Protector
When the fuse protector is burnout, take out the case of fuse protector and replace it with delay fuse protector (T3.15AL
250V).
Note:
(1) Users must turn off the power and disconnect the power line before operating.
(2) DO NOT break the power interface or lid of fuse case when replacing the fuse protector.
Figure 21 Fuse Protector (1)
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Figure 22 Fuse Protector (2)
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Appendix 1: List of Main Replaceable Components
SN Name Remark
1 Fuse protector T3.15AL 250V
2 Switching power supply
3 Boat-shaped switch
4 Power supply filter
5 Step motor(peristaltic pump) With plug
6 Power cord
7 Main board
8 Tube of peristaltic pump
9 Peristaltic pump
10 Cuvette
11 Ventilating Fan
12 Halogen lamp 6V 10W
13 Temperature sensor With plug
14 Light filter 340nm to 800nm
15 Signal board
16 Print interface board
17 Display interface board
18 Display screen
WARNING
1) The tube of peristaltic pump and fuse protector can be replaced by user and user must strictly follow the
replacement procedures specified in this file. If analyzer is damaged by false operation, URIT will
assume no liability to its safety, reliability and operation conditions.
2) The replaceable components should be provided by URIT. If you need to replace component, please
contact URIT for technical assistance.
30
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Appendix 2: The Factory Item Sequence and the Full Name of Test
Code
SN Item Name SN Item Name
1 ALT(Alanine aminotransferase) 19 K(Kalium)
2 r-GT(r-glutamyltransferase) 20 Cl(Chlorine)
3 ALP(Alkaline phosphatase) 21 Ca(Calcium)
4 CHE(Cholinesterase) 22 Fe (Ferrum)
5 D-Bil(Direct bilirubin) 23 P(Phosphorus)
6 T-Bil(Total bilirubin) 24 Mg(Magnesium)
7 ALB (Albumin) 25 AST(Aspartate amino transferase)
8 TP (Total protein) 26 LDH-L(Lactic dehydrogenase)
9 UREA(Urea) 27 CK(Creatine kinase)
10 BUN(Urea Nitrogen) 28 CK-MB（Creatine kinase MB）

α-HBDH(alpha-hydroxybutyric
11 Cr(Creatinine) 29
dehydrogenase)
LD-1(Lactate dehydrogenase
12 UA(Uric Acid) 30
isoenzyme)
13 GLU(Glucose) 31 PK(Pyruvate kinase)
14 CHO(Total cholesterol) 32 Ams(Amylase) (Blood)

LDL-C(Low density lipoprotein
15 33 Ams(Amylase) (Urine)
cholesterin)
HDL-C(High density lipoprotein
16 34 Hb(Hemoglobin)
cholesterol)
17 TG(Triglyceride) 35 CO2(Carbon dioxide)
18 Na(Natrium) 36 ACP(Acid phosphatase)
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Appendix 3: Table 1 of Maintenance Record
Unit: Daily/Weekly Maintenance Table of URIT-880 Y M

Daily Items 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean the panel
Rinse the tubing
after startup
Rinse the tubing
before shutdown
Fill the cuvette with
deionized water
Empty the waste
solution barrel
Turn off the power
Operator
Weekly Items Week 1 Week 2 Week 3 Week 4 Week 5

32
Clean the panel URIT-880 Standard Operation Process
Department Exec Date: Jan. 30th, 2015
Wash the waste
Room
solution barrel
Clean the incubator
Deep clean the
cuvette
Deep clean the
sample tube
Deep clean the
bleeder tube
deionized water
Turn off the power
-
Operator
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Appendix 4: Table 2 of Maintenance Record
Unit: Monthly/Half a Year/Special Maintenance Table of URIT-880 Year:

Check/Maintain Item January February March April May June July August September October November December
Clean the panel
Remove inner dust
Wash the waste
solution barrel
Clean incubator
Deep clean cuvette
Deep clean the
sample tube
Deep clean the
bleeder tube
Clean and maintain
the printer
deionized water
Turn off the power
Check/Maintain Item January February March April May June July August September October November December
Rinse/replace the
waste solution tube
Check/replace
cuvette
34
Check/replace URIT-880 Standard Operation Process
Department Exec Date: Jan. 30th, 2015
peristaltic pump
Room
Check/replace light
source lamp
Check/replace liquid
path
Operator
Note: Special maintenance includes rinsing/replacing the waste solution tube, checking/replacing cuvette, checking/replacing peristaltic pump,
checking/replacing light source lamp, etc.
35

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Hospital Version: V2.

(1) Breakage and Flammability

(2) Electric Shock

(3) Personnel Infection

(4) Personal Eye-protection

(5) Biohazard Precautions

Test parameters setting (check,

Preparation before test (serum,

Analytical test (calibration, QC

Print the results

4.1 Check before Start-up

4.2 Switch on the Power

Figure 1 Interface of Self-inspection

Figure 2 Login Interface of Software

Figure 3 Interface of Main Menu

4.3 Rinse after Start-up

Figure 4 Interface of Absorbance Measure Running

4.4Standby and Preheating

Figure 5 Interface (1) of Water blank A/D

Figure 6 Interface (2) of Water blank A/D

6. Measure Parameters Setting of Item

6.1 Set the Measuring Parameters of Item

6.2 Explanation with the Setting of Item Parameters

7. Add, Delete and Reset the Measurement Item

7.1 Add Measurement Item

7.2 Delete Measurement Item

7.3 Reset Measurement Item

8. Preparation before Measurement

8.1 Preparation before Measurement

8.2 Standard Operation of Collecting Serum before Measurement

8.3 Standard Operation of Using Reagent

8.4 Confecting the Mixed Solution of Reagent and Sample

Figure 7 Tools for Measurement

9.1 Measurement Item

9.2 Blank Measure

9.3 Calibrate Measure

9.5 Sample Measure

10. Edit and Print Results

10.1 Query the Measurement Result

Figure 8 Measure Results

10.2 Edit the Patient’s Information

Figure 9 List of Laboratory Sheets

10.3 Query the Laboratory Sheet

Figure 10 Searching the Laboratory Sheet

10.4 Modify the Results

10.5 Print the Laboratory Sheet

10.6 Export and Import Data

Figure 11 Interface of Export and Import

Figure 12 Interface of QC Data (ALT)

12. Reagent, Sample and Waste

12.1 Biochemical Reagent

13. Shutdown and Storage

13.1 The Process of Shutdown

14. Instrument Maintenance

14.1 Preparation before Maintenance

14.2 Maintenance Record

14.3 Daily Maintenance

14.4 Weekly Maintenance

14.5 Monthly Maintenance