TEMIS

Chemistry Analyzer
User’s Manual

Linear Chemicals instrument

Name TEMIS REF 1803050

Linear Chemicals, S.L.U.

 User’s Manual

Joaquim Costa 18, 2ª planta.

Montgat, Spain (EU)

Rev: 1.1e

CONTENT

SYMBOLS ON THE INSTRUMENT............................................................................................3

SAFETY PRECAUTIONS AND POTENTIAL HAZARDS.......................................................4

CHAPTER 1 A BRIEF DESCRIPTION......................................................................................8

1.1 INSTALLATION...................................................................................................................8
1.1.1 Unpacking.................................................................................................................8
1.1.2 Instruments location..................................................................................................8
1.1.3 Power requirements..................................................................................................9
1.1.4 Connect the instrument to AC power........................................................................9
1.1.5 Paper Installation.....................................................................................................9
1.1.6 Flow cell and cuvette system...................................................................................10
1.2 SYSTEM OVERVIEW.........................................................................................................10
1.2.1 Front View...............................................................................................................10
1.2.2 Rear view.................................................................................................................11
1.2.3 Flow cell and cuvette..............................................................................................12
1.2.4 Lamp and sipper pump............................................................................................12

CHAPTER 2 OPERATING PROCEDURES...........................................................................15

2.1 POWERING ON................................................................................................................15

2.2 BASIC OPERATING..........................................................................................................16
2.2.1 Mouse......................................................................................................................16
2.2.2 Keyboard.................................................................................................................16
2.2.3 Soft-keyboard..........................................................................................................16
2.3 MAIN MENU AND SYSTEM PARAMETERS SETTING.........................................................16
2.4 PROGRAMMING TEST PARAMETERS...............................................................................17
2.4.1 Modifying preprogram............................................................................................18
2.4.2 Programming a new assays.....................................................................................18
2.4.3 Calibration parameter............................................................................................19
2.4.4 Control parameter...................................................................................................19
2.4.5 Selecting a Mode.....................................................................................................20
2.4.6 Save the Change......................................................................................................21
2.4.7 Return......................................................................................................................21
2.5 PERFORM TESTS.............................................................................................................21
2.5.1 Test procedure menu................................................................................................21
2.5.2 Perform...................................................................................................................22
2.5.3 Changing test..........................................................................................................23

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CHAPTER 3 CALIBRATION BY STANDARD.......................................................................23

3.1 GENERAL.............................................................................................................................23
3.2 PROGRAM CALIBRATION......................................................................................................23
3.3 PERFORM LINEAR TESTS.....................................................................................................23
3.4 PERFORM THE CALIBRATION OF NON LINEAR TESTS.........................................................24
3.5 LIST CALIBRATION...............................................................................................................25

CHAPTER 4 CONTROL.........................................................................................................26

4.1 GENERAL.............................................................................................................................26
4.2 PROGRAM CONTROLS..........................................................................................................26
4.3 MEASUREMENT OF CONTROLS............................................................................................26
4.4 LIST CONTROLS...................................................................................................................27

CHAPTER 5 REPORT...............................................................................................................29

5.1 SUMMARY.............................................................................................................................29
5.2 PRINT BY PATIENT................................................................................................................29
5.3 PRINT BY TEST.....................................................................................................................32
5.4 PRINT HISTORY RECORDS....................................................................................................32

CHAPTER 6 REMOTE SERVICE...........................................................................................33

CHAPTER 7 CLOSE SYSTEM.............................................................................................33

CHAPTER 8 MAINTENANCE...............................................................................................34

8.1 GENERAL.............................................................................................................................34
8.2 CLEANING THE OUTSIDE......................................................................................................34
8.3 CLEAN PROCEDURE FOR THE FLOW CELL..........................................................................34
8.3.1 Washing when Changing tests........................................................................................34
8.3.2 Washing twice a day.......................................................................................................34
8.3.3 Closing the system by the closing procedure..................................................................34
8.4 REPLACEMENT THE LAMP...................................................................................................35
8.5 REPLACEMENT OF THE INTERNAL TUBING..........................................................................35
8.6 REPLACEMENT THE FUSE....................................................................................................35
8.7 TROUBLE SHOOTING............................................................................................................35

APPENDIX I: GENERAL SPECIFICATIONS..........................................................................37

APPENDIX II: SERIAL CONNECTION PROTOCOL............................................................38

1. SERIAL PORT STATE...............................................................................................................38

2. MESSAGE FORMAT.................................................................................................................38
3. Send over.............................................................................................................................38

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Symbols on the instrument

This symbol means that the labeled item is hot while the
instrument is in use. Don’t touch the labeled item as you
could be scalded.
The symbol is labeled on the lamp support of optic system.

This means that the labeled item could lead to personal injury
and/or damage to the analyzer.
The symbol is labeled beside the power outlet and some
external interface.

Cautions should be followed carefully to ensure your

instrument work correctly and to avoid unnecessary personal
injury

The symbols for “SERIAL NUMBER”, The serial number shall

be after or below the symbol, adjacent to it.

The symbol means the product is in vitro diagnostic medical

device.

The symbol indicates the manufacturer and its address, after

which are shown its name and address.

The symbol indicates EU representatives of the manufacturer

and their addresses, after which are shown their names and
addresses.
The symbol indicates biological pollution, marked in the part
where the instrument contacts the clinical reagent. The
symbol appears in black side and yellow background.

Symbols on the sales packaging

The symbol means that the environment of instruments must

be damp proof in the course of transport, and instrument must
be kept in a dry environment.

This means that instrument should handle with care in the

course of transportation, so as not to damage it.

The symbol means the instrument packaged should not be

upended at any time

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The symbol means that the level piled up can't exceed 8

layers, as not to damage instrument.

The symbol indicates temperature range of the analyzers

during storage and transportation.

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Safety Precautions and Potential Hazards

General

Before you start installing and working with the analyzer, you should read the safety
precautions and regulations shown in this chapter.

Operator Qualification

Please note that the operation with Semi-auto Chemistry Analyzer should be carried out
only by the doctor or clinical inspector who has undergone necessary training provided
by the sales agent.

Service Technician Qualification

To install, maintain and repair the instrument, a service technician has to be trained on
the instrument by the manufacturer or their representative. A service technician is also
expected to be familiar with the normal operation of the instrument as described in the
User’s manual and the special operations as described in the service manual.

Electrical

To use analyser safely, pay attention to the following items:

To prevent the risk of electrical shock and/or damage to the instrument Operator should
not open the white cover of the instrument. Only authorized personnel, for example,
service technicians, may open the instrument to perform maintenance or repair.

Touching the main board when the power is on may cause severe injury or death. Any
problem, please ask for helps from your supplier.

Mechanical

There is no risk presented by the mechanical parts of the instrument when the instrument
is closed. If the covers of the instruments are removed, mechanical parts could cause
personal injury or the instrument may be damaged if the following advice is not being
considered: DO NOT wear loose garments or jewellery that could catch in mechanisms.
DO NOT put your fingers/hands into the pathway or any part while the analyzer is in
operation. DO NOT attempt mechanical repair unless the instrument is not in operation or
OFF.

Lamp

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The source lamp becomes extremely hot during operation; never touch the lamp when it
is on! Look directly into the light path of the lamp may cause eyes damage, too.

If the lamp needs to be changed, always switch off the lamp by switching off the
instrument and then wait until the lamp has cooled down.

Chemical

The operator is responsible for taking all necessary precautions against hazards
associated with the use of clinical laboratory chemicals. Specific recommendations for
each reagent used with the analyzer are normally found on the manufacturer’s package
inserts or the on the product information sheets for each chemical. Wipe up any reagent
spillage on the instrument immediately.

Biohazardous Materials

As with all vitro diagnostic equipment, patient samples and serum-based quality control
(QC) products that are assayed on this system, as well as all waste from the waste
container, should be treated as the potentially biohazardous. All materials and
mechanical components associated with the sampling and waste system should be
handled according to your facility’s biohazard procedure. Use the personal protective
equipment recommended by your facility when handling any of these components.
Detailed recommendations:

- Samples

Treat all samples as potentially biological pollutions and infectious. If any sample is spit
on the instrument, utilize the correct personal protective equipment (PPE- gloves, lab
coat, etc..), wipe it up immediately and clean the contaminated with a disinfectant.

- Waste solutions and solid wastes

Avoid direct contact with waste solution and/or solid waste. Both should be handled as
potentially biohazardous.

Dispose of waste solution and/or solid waste according to the relevant governmental
regulations.

Consult the reagent manufacturer for information on the concentrations of heavy metals
and other toxic constituents in each reagent.

- Biohazardous parts

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Avoid direct contact with the sipper tubing and all parts of the sample flow path. Treat
these areas as potentially biohazardous and /or infectious
- Reagents

Avoid direct body-contact with reagents. Direct body-contact may result in irritation or
damage to your skin. Refer to the manufacturer’s reagent kit box and package inserts, or
product information sheets for specific instructions.

Avoid direct body-contact with cleaning solution. Direct body-contact amy result in skin
irritation or damage. Refer to the manufacturer’s kit box and package inserts, or product
information sheets for specific instructions.

ATTENTION! Cautions

Require for Samples and Reagents, calibrators and controls.

This Semi-auto Chemistry Analyzer is a Reagent open system. But before the testing, the
following items should be noted first.
Generally, all the reagent and samples have to be stored and prepared as per the
manufactures’ instructions. Before your test, please check the following.
Check the expiration date of the material
Check if the reagent is stored properly as the requirement. (E.g. cooled or frozen storage
before using)
Check for proper programming in parameter setting menu according to the specified
reagent instructions.
Check for volume required for each material.
Check for proper and calibrated pipette to prepare the solution.

Additional Precautions

- Flammables

Avoid using dangerous flammable material around the instrument.

- Accuracy/Precision of the Measured Results

For proper use of the instrument, measure control samples and monitor the instrument
during the operation.

An incorrectly measured result may lead to an error in diagnosis, thereby posing a

danger to the patient.

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Treat all reagents according to the manufacturer’s recommendations. Refer to the

reagent kit box and package inserts, or product information sheets for specific
instructions.

Make sure that the sample/reagent mixture does not contain any blood clots, dust or
other insoluble contaminants. If insoluble contaminants are contained in the sample,
correct measuring values may not be obtained.

- Application

The instrument is designed for clinical chemistry test analysis using water-soluble
samples and reagents.

Please note that other types of analysis may not be applicable to the instrument.

- Operation and Maintenance

During operation and maintenance of the instrument, proceed according to the instructors
and do not touch any parts of the instrument other than those specified.

Never leave a Reagents/sample mixture in the flowcell for longer than necessary. Always
clean the flowcell after a batch of measurement and keep the flowcell filled with distilled
water when not in use.

Verify the front covers closed while the instrument in operation.

Avoid touching the mechanism, such as the sipper mechanism inside the instrument,
while the instrument is operating. This may cause operation stop or damage the
instrument.

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Chapter 1 A Brief Description

This instrument is a universal photometric Semi-auto chemistry analyzer. The advanced

software based on Windows CE gives the instrument friendly interfaces which meet the
individual requirements of clinical chemistry laboratory.
 47 of the most commonly assays are stored in the flashing RAM of the
instrument, which enables user can start working right away with the
instrument. 130 of assays can be programmed.
 6 Analytical Modes:
Endpoint
Bichromatic
Liner regression
Multi-Calibration
Two-point
Kinetics
 The user could connect the unit to the PC of clinic lab by RS232 interface.
 Options:
Keyboard
 Power-off protection, real-time data saving.

1.1 Installation

1.1.1 Unpacking
Carefully unpack the instrument, removing it from its plastic bag. Keep the
boxes and packaging material until being assured that nothing is missing, that
the unit has no (internal) transport damage and are working properly.

1.1.2 Instruments location

The instrument should be located on a flat surface, which is not exposed to
heavy vibrations (i.e. centrifuges, etc.) and direct sunlight. The ventilation
openings in the bottom plate and at the rear of the instrument should not be
blocked.

Note! Environmental requirements

Ambient temperature (operating): 0℃～40℃
Relative humidity:≤85%
Transport and Storage Environment:
Temperature: -10℃～40℃
Humidity:≤85%
Atmospheric Pressure: 86kPa～106kPa

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1.1.3 Power requirements

 a.c.110V~220V
 50/60 Hz
 80VA

1.1.4 Connect the instrument to AC power

Plug the power cord into the instrument. Plug the power cord into an AC
electrical wall outlet.

ATTENTION! Cautions
 AC power outlet must be connected to ground.
 Shut (Power) off the power if smog, special smell or special
sounds from the inside of the instrument, and contact your
supplier.
 Hold the connector when you pull off the power cord. Never
pull the cord directly.

1.1.5 Paper Installation

 Remove the paper cover by pulling up at the top end of the cover.
 Unroll about 10 inches of paper and place the roll on the table behind the
instrument.
 Feed a cleanly cut edge of the paper from the back into the printer.
 A ragged edge or wrinkled paper will be difficult to load and could cause a
paper jam.
 Feed just over 1 inch of paper in and then press the feed paper key
several times to feed over 3 inches of paper. Drop the roll of paper into
the printer paper well in back.
 Feed the paper through the paper slot of the cover, and then close the
cover.

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1.1.6 Flow cell and cuvette system

Figure 1.1
 Remove flow cell cover
 Insert the flow cell or cuvette into the flow cell holder
 Make sure the surface with characters of the flow cell is faced to user.

Note!
Keep the surface of the flow cell or cuvette clean. Don’t touch it by
fingers.

1.2 System overview

1.2.1 Front View

1) Printer cover & Pump cover: Open the cover, user could change the
lamp or maintain the pump.
2) Flow cell cover
3) Sample tube bracket
4) Sample tube
5) Sample button
6) Paper feed button
7) Rinse button
8) LCD Screen

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Figure 1.2

1.2.2 Rear view

Figure 1.4
1) Power switch
2) Fuse
3) AC power connector
4) Fan
5) Pump
6) Drain port
7) RS-232 port
8) SD card

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9) USB port
10) Brightness
11) Lan port
1.2.3 Flow cell and cuvette
The following sketches will help you locate and identify the flow cell parts.

Figure 1.5

Figure 1.6

1.2.4 Lamp and sipper pump

1) Remove the flow cell cover.

2) The sketches of the lamp and the sipper pump are as show in the following
figure1.7, 1.8:

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ATTENTION! Cautions
The source lamp becomes extremely hot during operation; never touch the
lamp when it is on! Look directly into the light path of the lamp may
cause eyes damage, too. If the lamp needs to be changed, always
switch off the lamp by switching off the instrument and then wait until
the lamp has cooled down.

Figure 1.7

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Figure 1.8

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Chapter 2 Operating Procedures

2.1 Powering on
Turn the instrument on using the power switch on the rear panel. The screen will
display the following:

Screen 2.1 System initialization

The instrument will be waiting the lamp stable in 2 minutes. Then the screen will
display as following:

Screen 2.2
Raise a test tube of distilled water up to the aspiration flow cell sample tube and
press the “Sample Button”. After you hear the control unit valve cycle, remove the
tube. The Semi-auto chemistry analyzer will now read and save the absorbance
reading for water for all seven filters in the machine. If the absorbance reading is too
high or too low, the following screen will displayed

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Screen 2.3
Select “No”, the system will ignore the deviation above and move to test menu.
Select “Yes”, and raise the test tube of water up to the aspiration tube, and press
Rinse to rinse the flow cell. After a few seconds, press Rinse again to stop the rinse,
and then press the “Sample Button”. If the above screen still displayed, contact the
supplier.
2.2 Basic operating

2.2.1 Mouse
The instrument has a serial port mouse for PC (USB interface)

2.2.2 Keyboard
Connect the ext. Keyboard to the instrument when the analyzer powered off.
You can use the keyboard just like to operating a PC keyboard.

2.2.3 Soft-keyboard
Use mouse to click the icon (soft-key) to pop a soft-keyboard, (Screen 2.5 Soft
keyboard) and click the icon again, the soft-keyboard will be close

Click here when dragging

Screen 2.4 icon (soft-key) Screen 2.5 Soft keyboard

2.3 Main menu and system parameters setting

After the instrument initialization, the screen will display the following:

Screen 2.6 Main menu

Click “System”,

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Screen 2.7 Sys setting menu

1) Setting time and date

2) Printer Select
 Printer Inside: If you select “Printer Inside”, the Printer type can not be
selected.
 Printer Outside: If you select this, you need to select the printer type also.
 Print instantly: If you select this, test result will be printed instantly.
3) Inputting the Hospital name

Select “Serial trans.”, the screen will display the following:

Screen 2.8 Serial transfer

The test result can be transferred to Desktop PC through standard RS232 Cable; the
serial port of PC should be set as following:
19200 baud, Even Parity, 8 bit of data and 1 bit of stop
Details of Protocol please see Appendix II.

2.4 Programming test parameters

THE INSTRUMENT has a built-in menu of 130 assays. 47 assays of most commonly
applied data reduction formulae are pre-programmed.

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2.4.1 Modifying preprogram

Click “Setting” in main menu. The screen will display the following:

Screen 2.9 Test survey menus

1) Click the button which will be modified, such as “UA”, The screen will
display the following:

Screen 2.10 Test Enter menus

 Select “Edit” to modify the parameter of the test.
 Select “Print” to print the parameter of the test.
2) Modifying parameters

Screen 2.11 Programming menu

3) Click “Save” button to save the modification, or click “Exit” to ignore.

2.4.2 Programming a new assays

1) Select a free button from the “User defined test” , then click the “Edit” button
2) Input parameters

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3) Save the input

2.4.3 Calibration parameter
Select “Calibration”, “Calibration setting” window will be open.

Screen 2.12 Calibration setting menu

1) Calibration for linear tests

 Num od std.: This parameter means that how many standards (with the
different concentration) will be used for calibration.
 Repeat times: This parameter determines how many times will
repeat for the same concentration. The results of multiple
measurements will be averaged by the system.
 Select “OK” to confirm the selecting.
 Select “Exit” to go back to above menu with modify

2) Calibration for no-linear tests

 Num od std.: This parameter means that how many standards (with the
different concentration) will be used for calibration.
 Repeat times: This parameter determines how many times will repeat
for the same concentration. Possible inputs are 1, 2 and 3.The results
of multiple measurements will be averaged by the system.
 Select “OK” to confirm the selecting.
 Select “Exit” to go back to above menu.

2.4.4 Control parameter

Select “Control” for programming control. The follow window will appear:

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Screen 2.13 Controls setting menu

a) Control 1 and control 2: Two controls could be defined.

b) Mean value: Input the mean value of the control.
c) Minimum: Input the minimum of the control.
d) Batch number: The different batches of a control will have
different values. Enter the batch number.
e) Select “OK” to confirm the programming. Select “Exit” to go back the above
menu without modify.

2.4.5 Selecting a Mode

In the menu of the “Programming” (screen 2.10), click “Mode”. A window will
be pop-up.

Screen 2.14 Measurement mode menus

Select “Yes”, the following screen appears:

Screen 2.15 Change mode menus

a) Endpoint
After a required incubation time, the reaction reaches its maximum color
development, or it’s Endpoint. The color of the reaction will remain stable
and constant for certain period of time. During this time a measurement in
Absorbance is taken.
b) Endpoint Bichromatic
Bichromatic is actually endpoint determination measured at two different
wavelengths. The advantage is that some unwanted interference due to
the color of the serum sample can be eliminated by subtracting the

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measurement done with the second wavelength filters. This can be done
when you select a sub-wavelength in “Parameter change” menu. It was
described in 2.4.1.
c) Endpoint determinations against a standard Curve
d) Endpoint determinations against a Multi-standard Curve
This is a normal endpoint determination, in which linearity may not be
perfect throughout the whole range that is interest. As a result it is
calibration curve (a number of standards) instead of a single standard.
e) Kinetic
Kinetic determinations are tests whose enzyme activity is measured
continuously over a certain period of time and finally referred to 1 minute.
f) Twopoint
After a pre-defined incubation time, two absorbance readings are taken at
different and programmed time interval. From the delta absorbance
between the two measurements the final result is calculated. Each of the
measurements taken is a mean of a large number of readings taken in
quick succession.

2.4.6 Save the Change

After select the measure mode, Select “Save change” to save the selection.
The menu will change to the “test enter” menu. Select “Enter” to perform the
test procedure.

2.4.7 Return
Select “Exit” to go back to the “Setting” menu.

2.5 Perform tests

Select the test to be performed in the menu of “test overview”, and click “OK” to go to
the menu of “test procedure”.

2.5.1 Test procedure menu

The menu of “test procedure” is displayed as following:

Screen 2.16 Test procedure menus

1) Factor window: Factor

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2) ABS window: Display ABS of test

3) Result window: Test result
4) Control: Perform the control test.
5) Calibration: Perform the calibration test.
6) Print: Print the test result.
7) Change No.: Change the sequence number tested.
8) Time: Display the time.
9) Temperature: Display the temperature of the flow cell.
10) Lamp: Show the status of the lamp: On/Off.
11) Wavelength: Show the wavelength selected.
12) Instruction window: Display the instruction information.
13) Exit: Return back to main menu.
14) Reaction window: A curve will be displayed to represent the reaction.

2.5.2 Perform
Following the instructions displayed on the “instruction window”.

Screen 2.17

1) Instruction window: Aspirating distilled water

Put a tube with distilled water under the sample tube and press Sample
key (figure 1.2).
The measure result will be displayed on the “result window” and on the
“reaction window”.
2) Instruction window: Aspirating reagent blank or Aspirating Sample
blank , Hold the reagent blank or sample blank under the sample tube and
Press Sample key. The programmed volume will be aspirated and measured.
The
Process and result of the measurement will be displayed.
3) Instruction window: Aspirating Sample
Hold the sample under the sample tube and press Sample key. The
programmed volume will be aspirated and measured. The process and
result of the measurement will be displayed.
4) Calibration: will be described in Chapter 3
5) Control: will be described in Chapter 4

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2.5.3 Changing test

When changing over from one test to another, washing of the flow cell is
required, to prevent reagent carry over, causing wrong calibration and
measurement result.
To wash the flow cell:
 Place a container of distilled water under the sample tube. Press Rinse
key. The aspiration/flow cell system will be washed continuously now, until
the Rinse key is pressed again. Let the flushing continue for about 30
seconds.

Chapter 3 Calibration by standard

3.1 General
Certain tests require calibration by one or more Standards. Calibration results are
stored in the flash memory of the analyzer and can be used again for future
measurement.
Calibration can be programmed and subsequently done for different measurement
mode: Endpoint or Twopoint. For Endpoint, the calibration could be with/without
Reagent Blank and/or Sample Blank. For Twopoint, the calibration could only be with
or without Reagent Blank.
The calibration by standard should be performed depending on the stability of the
reagents, batch of the reagent, and type of test. The previous calibration data in the
flash memory will be overwritten by the new ones.
3 procedures should be performed for the calibration by standard:
 Program calibrations
 Measurement of calibrations
 List calibrations

3.2 Program calibration

The calibration parameters could be programmed in the menu “parameter modify”,
see the screen 2.10. The setting was described in 2.4.2.

3.3 Perform linear tests

For linear tests, the relation between Absorbance and Concentration is a (linear)
straight line. This type of test is normally calibrated with one or more standard(s) of 1
concentration and with or without Reagent Blank.

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The calibration can be run at any time during a test run, after the test has been
selected. Select “Calibration” in menu of “test procedure”:
1) Instruction window will appear: Aspirating Standard “#”
Hold the standard sample “#” under the sample tube and press Sample key.
The programmed volume will be aspirated and measured. The process and
result of the measurement will be displayed.
2) Instruction window: Aspirating Standard “#”, Repeat #
Follow the instruction on the “instruction window”.

Screen 3.1
3) The result will be displayed on the result window, and the standard curve will be
displayed in same time. User can save and print the result

3.4 Perform the calibration of non linear tests

Non linear tests are those tests where the relation between Absorbance and
Concentration is not linear. These tests are normally calibrated on more than 1
standard of different concentrations. The analyzer has a special arithmetic to link the
calibration points to a calibration curve. The measurements for patient or controls
are then interpolated automatically depending on the curve.

The calibration can be run at any time during a test run, after the test has been
selected. Select “Cal.” in menu of “test procedure”:
1) Instruction window will appear: Aspirating Standard “#”
Hold the standard sample “#” under the sample tube and press Sample key.
The programmed volume will be aspirated and measured. The process and
result of the measurement will be displayed.
2) Instruction window: Aspirating Standard “#”, Repeat #
Follow the instruction on the “instruction window”.
3) The result will be displayed on the result window, and the standard curve will be
displayed in same time. User can save and print the result.

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Screen 3.2

3.5 List calibration

Select “Calibration” in “Main menu”, to list the calibrations. The list screen will be
displayed. Select test and click “OK”, following screen will be displayed:

Screen 3.3
1) Print the result by selecting the “Print”.
2) Select “Exit” to go back to the above menu.

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Chapter 4 Control

4.1 General
The control program gives the possibility of storage and statistical evaluation of
controls measured on the instrument.
For all 130 tests programmed in the unit, 2 controls can be defined. The result of
controls for 130 tests of 365 days could be stored automatically. 3 operating should
be performed for the controls:
 Program controls
 Measurement of controls
 List statistics

4.2 Program controls

The control parameters could be programmed in the menu “parameter modify”, see
the screen 2.15. The setting was described in 2.4.3.

4.3 Measurement of controls

A control can be run at any time during a test run, after the test has been calibrated.
Select “Controls” in menu of “test procedure”, a window will be open as following:

Screen 4.1

1) Choice “1” if only measuring 1 control, and choice “2” if 2 controls will be
measured. Select “OK” to confirm the choice.
2) Instruction window will display: Aspirating Control “#”
Hold the control requested by analyzer under the sample tube and press
Sample key. The programmed volume will be aspirated and measured. The
process and result of the measurement will be displayed.
3) The result will be added to the statistical memories automatically. The
evaluation of control results can be accessed through the main menu and
described in 4.4.

4.4 List controls

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Select “Control” in main menu, to list the statistics of controls. The list screen will be
displayed:

Screen 4.2
1) Select test and month, Click “OK”.
2) The statistic of the controls will be displayed on the screen:

Screen 4.3

3) Print the result by selecting the “Print”.

4) Select “Exit” to go back to the above menu.

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Chapter 5 Report

5.1 Summary

In this part, three report styles are provided: “By patient”, “By test” and “History”, you can
select one style from three according your requirement.

Screen 5.1
5.2 Print by patient

In the state of Screen 5.1, select “By patient”, a new window will be open.

Screen 5.2
Operation guide:
1. Update patient information
Select one patient, the correspondent line is activated. Input name, department, age and
sex, click “Update”, then the patient information is change into what you have input.

2. Add a patient
If you want to add one or more new patients, you can click “Add” after the patient
information has been input. Each new patient will have a different patient NO. If you want
to test the patient’s sample, just change the present sample NO into the patient NO.

3. Select print mode

In this part, seven print modes are provided, “General”, “Liver function”, “Kidney function”,
“CK enzymes”, “Lipids”, “Iron” and “Electrolytes”.

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General: Print all item tested in the test order.

Liver function: If this mode is selected, 18 items are included.
1 ALB
2 TP
3 GLB
4 ALB/GLB
5 T BILI
6 D BILI
7 I BILI
8 AST
9 ALT
10 AST/ALT
11 GGT
12 ALP
13 LDH
14 LDH/AST
15 GGT/AST
16 TBA
17 PALB
18 GLU
Kidney function: If this mode is selected, 6 items are included.
1 UREA
2 CR
3 UA
4 TP
5 ALB
6 GLU
CK enzymes: If this mode is selected, 4 items are included.
1 CK
2 CK-MB
3 AST
4 LDH
Lipids: If this mode is selected, 8 items are included.
1. CHOL
2. TRIG
3. HDL-C
4. HDL-C
5. ApoA
6. ApoB
7. ApoA/ApoB
8. ApoE
Iron: If this mode is selected, 2 items are included.
1 IRON

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2 TIBC
Electrolytes: If this mode is selected, 11 items are included.
1 K
2 Na
3 Cl
4 Ca
5 Mg
6 P
7 Cu
8 Zn
9 GLU
10 AMS
11 LPS

Input patient NO which need to be printed, patient NO can be input as following:

1. 3,6
2. 1-5
3. 1-4,5-6
4. 3,4,5-7
5. If all patients need be selected, you can select the check box “select all”

Click “Print”, the report will be printed. If some item in the mode hasn’t been tested, there
will have no correspondent data in the report.

4. Input no-chemistry item

Setting: Directly inputting a no-chemistry item and result is also permitted, this item
will be printed in the “General” mode report. In the window of “By patient”, click
“setting”, a window will be open as Screen 5.3. “Test name”, “Unit”, “Normal (low)”
and “Normal (high)” are all need to be input, and each can’t be longer than eight
characters. All the no-chemistry items will be saved if THE INSTRUMENT is closed
correctly.

Screen 5.3

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Edit: In the window of “By patient”, select one patient line, and then click “setting”.
In the “Item edit” window, input no-chemistry item result, this item will be printed in
General mode report.

5.3 Print by test

In the state of Screen 5.1, click “By test”, a new window will be open.
Select the Item to be printed, then click “Print”, all test result of selected item will be
printed. If you want print all items, just select the “Select all” check box.

5.4 Print history records

In the state of Screen 5.1, click “History”, a new window will be open.

Screen 5.4

THE INSTRUMENT can store 3500 pieces of records at most. In the new window, drag
the scroll bar, you can see all test results of history.
During the operation of print, delete and data transfer, click "Select all" check box, you
can do the operation on all records. Input the order number of patient, you can do the
operation on selected records.
Patient No. can input as following:
1. 3,6
2. 1-5
3. 1-4,5-6
4. 3,4,5-7

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Chapter 6 Remote service

THE INSTRUMENT Lite Version can’t support remote service!

Chapter 7 Close system

At the end of the working, you must perform the Closing procedure by selecting
“Power off” in the “Main menu”.
1) The system will store the parameters and the results of tests.
2) The screen will display “aspirating distilled water”.
3) Place a container of distilled water under the tube. Press Aspiration key ,
Rinse will take few minutes
4) The screen will display “ Please switch off the instrument”
5) Turn off the power.

ATTENTION! Cautions
Never power off the system without performing the closing procedure.
It will cause that lost of the data and influence the measurement.

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Chapter 8 Maintenance

8.1 General
The THE INSTRUMENT is a Clinical Semi-auto Chemistry Analyzer, which requires
only a minimum amount of maintenance.
Some general maintenance is necessary to keep the instrument in a optimal
condition.

8.2 Cleaning the outside

Always keep the outside of the instrument clean and free dust. You can wipe the
outside with a damp (not wet) cloth and a mild detergent
Wipe the display screen with a soft, nonabrasive cloth.

ATTENTION! Cautions
Do not use any type solvent, oil, grease, silicone spray, or
lubrication on the instrument.

8.3 Clean procedure for the flow cell

The inside of the flow cell should be kept as clean as possible, to assure good and
reliable measurements.
To keep the inside clean, follow the following procedures:

8.3.1 Washing when Changing tests

When changing over one test to another, some washing of the flow cell is
required.
To wash the flow cell:
 Place a container of distilled water under the tube. Press Rinse key.
The /flow cell system will be washed continuously now, until the Rinse
key is pressed again. Let the flushing continue for about 2 minutes.

8.3.2 Washing twice a day

The following procedure is needed twice a day, to wash out those residues
from the wall of the flow cell, which cause bad filling of the cell:
 With the distilled water with detergent. Let the detergent stay in the flow
cell for 2-3 minutes. The distilled water added some detergent is better.
The ratio of the detergent is depending on the detergent used. Normally a
2-5% solution is adequate.
 Rinse with distilled water without detergent for about 1 minute.

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8.3.3 Closing the system by the closing procedure

At the end of the working, you must perform the Closing procedure by
selecting “Power off”.
1) The system will store the parameters and the results of tests.
2) The screen will display “distilled water”.
3) Place a container of distilled water under the tube. Press Aspirate key,
Rinsing will take few minutes. Leaving the distilled water inside the flow
cell.
4) The screen will display “ Turn the power off”
5) Turn off the power.

ATTENTION! Cautions
Never leave Sample/Regent inside the flow cell for a long period of
time.

8.4 Replacement the lamp

8.5 Replacement of the internal tubing
8.6 Replacement the fuse
The fuse is situated at the rear side of the analyzer. It is mounted in the fuse holder
beside the power switch. Pull out the fuse holder lid and the fuse can be replaced
easily.
Replacement fuse should be the following rating:
Fuse rating: 250V, 3.15A

ATTENTION! Cautions
Never mount fuse of wrong rating!

8.7 Trouble shooting

1) The analyzer could not power on --- Check the power cord
--- Check the fuse
--- Check AC power
2) The lamp couldn’t turn on --- Check the connector of the lamp
--- Change the lamp
3) Not Print --- Check the cable
--- Assure that printer powered on
firstly.
4) Non aspiration of sample --- Check the pinch pump
--- tubing

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--- Rinse the flow cell

5) The result of water blank is too high --- Check the lamp
--- Change the distilled water
--- Rinse the flow cell
6) Repeat result
7) Controls out of the target --- Reagent validity
--- Assure the program is correct.
--- The quality of controls
--- To test again by changing the
mode
--- Check the flow cell and select a
new reagent and control
8) The aspirate volume not stable --- Liquid system blocked,
Rinse the tubing, or change
the tubing.

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Appendix I: General Specifications

Net Weight: 8 kg

Dimension: 350mm(L)×330mm(W)×165mm(H)

Power supply: a.c.110V~220V,50Hz/60Hz

Power consumption: 80VA

Fuses: T3.15AL250V, Φ5x20mm

Operating condition: 0℃ ~40℃; RH ≤85%

Storage condition: -10℃ to 40℃; RH ≤85%

Display: 7” color LCD (640x240, 256 colors)

Measurement range: 0.000~2.500 Abs

Resolving power: 0.001 abs (display), 0.0001 abs (calculation)

Interference filters: 340nm, 405nm, 500nm, 546nm, 578nm, 620nm, and 670nm

Half band width: ≤10nm

Lamp: Tungsten halogen lamp 6V/10W

Temperature control: 25℃, 30℃, 37℃ ±0.1℃ and ambient temperature

Flow cell: 30µl quartz flow cell.

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Appendix II: Serial Connection protocol

1. Serial port state
Data is transmitted at 19200 baud,
With 1 stop bit
8 data bit and Even Parity

2. Message format
The initial parameter must be the capital letter “R”, each line consists of 12 data in
following order:
Parameter Possible values Space mark
Initial parameter “R” ,
Patient name Character or NULL ,
Department Character or NULL ,
Sex Character or NULL ,
“0” = Male
“1” = Female
Patient No. Character ,

Name of test Character ,

Result Character ,

Units of measurement Character ,

Checksum Character

Checksum = All of parameter + All of space mark

3. Send over
THE INSTRUMENT sends a character string “TRANSFER FINISH”, when the task
has been completed.

Example:
R, Biachi, 0, 43, 1, TP, 136.00, g/L, 0794
R, Rossi, 1, 40, 2, TP, 147.00, g/L, 0765
R, Tony, 0, 6, 3, TP, 35.00, g/L, 069d
TRANSFER FINISH

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