USER MANUAL

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 Company reserves the right to review or change the content of the user manual in course of any technical development without any prior notice

Manual Version: M30002

Preface

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 Congratulations on purchasing a Mispa i3 analyzer. We hope you will find working with your analyzer satisfying and successful. In the
following chapter "Mispa i3 user manual" you will find a first overview of the analyzer and overview of the device's functionality. Furthermore,
you will receive information on safety, on liability and warranty, and on indications or contraindications of your analyzer. For further and
more detailed information, please read the corresponding chapters

1. Product Description

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 Mispa i3 is an automated Cartridge based specific protein analyzer that offers the benefits of fully Auto analyzer, like high precision and quick
turnaround results, for all protein assays. It is for the protein determination and it supports the clinical management of variety of disease, such as
cardiovascular risk, inflammation, kidney disease and several other specific protein assays.

Front View Rear View

1.1 System introduction

Mispa i3 Cartridge based specific protein analyzer is comprised of the following divisions

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 a. Analyzer with inbuilt printer.
b. Prefilled and sealed cartridges along with sample cup for specified test.
c. Smartcard containing test details and calibration curves.
d. Accessories.

1.2 Main analyzer

a. Analyzer consists of touch screen 7” color TFT display to guide user.

b. Up/Down assembly and mixing system for the auto aspiration and mixing of reagent and sample.
c. Inbuilt and handheld barcode reader facility for the automatic test detection from the specified cartridge and for patient ID entry.
d. Measurement module: Measurement module for measuring the intensity of the light, which comes out from the cartridge.
e. Wash solution & Waste bottle assembly meant for washing the system of analyzer.
f. In built printer, for automatically printing the test results and other details.

1.3 Prefilled and sealed cartridges along with sample cup for Specified test.

a. Cartridge with reagent of specified test are prefilled and sealed with foil.
b. A barcode label is placed at the side of cartridge that describes the test name along with its details. It has four smaller cells to hold
the required reagents of specific test.
c. The last larger cell is the reaction cell used to mix the reagents and patient sample, which is placed in the sample cell of the cartridge.
Once the reaction is completed, the measuring takes place in the same cell.

1.4 Smart Card containing test details and calibration curves.

IC card contains the information related to specific test calibration graph, lot n o . , total n o . of test available, expiry and test specific
encoded data. It is possible to set the Calibration data either into the card mode or to analyzer mode. Once the IC card is inserted in the
analyzer, complete data will be stored in the analyzer memory. If it is in the card mode, analyzer makes use of the data from the IC card.

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1.5 Symbols and Terms

1 SN Serial Number

2 Reference Number

3 Attention

4 Consult Instructions for use

5 Manufacturer

6 Biohazards Warning

7 COM1 Communication Port 1

8 COM2 Communication Port 2

9 WASH For connecting wash solution bottle (Tube and sensor)

10 WASTE For connecting waste bottle (Tube and sensor)

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1.6 List of Accessories

Title Quantity

Mispa i3 1

Power connection cable 1

Operator’s manual 1

Final Check Report 1

Waste & wash solution bottle along with tubing’s & connectors 1

Waste & wash solution bottle stand 1

Pipette 20-200 µL 1

1.7 Manufacturer Liability and Warranty

Legal liability and warranty claims are expressly excluded in the following cases:

a. gross negligence or willful damage of the device, parts thereof or consumption material
b. unauthorized opening of the device by untrained personnel (without proper service training)
c. force majeure (e.g. stroke of lightning, water damage, fire)
d. nonobservance of user manual and package inserts

For their products, Agappe Diagnostic Limited extends a one-year warranty according to Indian IVD Protocol starting with the date of purchase.
Consumables (because of shorter shelf life) and parts subject to wear (they should be replaced on a yearly basis) are expressly excluded from
this warranty.

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 2. Safety

2.1 Introduction

The following chapters concern the safety of the person operating the device.

Read these chapters carefully prior to starting up the analyzer because they contain general safety warnings, warnings concerning the
personal safety of the person operating the device, and warnings for the protection of the device.

Displaying the following safety warnings does not relieve the operating the device from adhering to the safety measures of the
facility.

2.2 Responsibility / Training of the operator

a. The Mispa i3 analyzer must only be used and operated by trained personnel. An employee of the manufacturer or of an authorized
distributor will introduce the operation procedures.
b. Every user is responsible for adhering to safety, health, and legal regulations, and operating the device only according to its intended use.
c. Interpreting the results and diagnosing must be left to a medical practitioner. Operating the device for home testing is strictly forbidden.

2.3 General safety instructions

a. Prior to operating Mispa i3, read the entire operator’s manual especially the instructions for sample taking. If you have any questions,
please contact the manufacturer or authorized distributor.
b. Every person working with the device must be acquainted with the relevant safety rules prior to operating the device and these rules
should be kept at hand all the time. Please pay attention to all general safety rules for laboratories such as personal protective
equipment, and the applicable disinfection and hygiene regulations.
c. In case of unintentional skin contact with potential infectious material, e.g. human blood/urine, disinfect the area with a suitable
antiseptic solution.
d. The system solution is not corrosive, toxic or strongly skin irritating. In case of skin contact with system solution, washing of affected area

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 with water is appropriate.
e. To avoid risk of electric shock, do not place the instrument or its power supply in water or other liquids! If the cable or the power supply
adapter is damaged in any way, you must not continue using the power supply.
f. Never touch the plug of the power supply adapter with wet hands. The power supply adapter must only be used indoors and must be
protected from humidity.

2.4 Product specific safety instructions

a. The device may only be used for the intended use with special attention to the defined usage restrictions and constraints to be strictly
adhered (in case of need contact the manufacturer).
b. In case of unintended use, it is pointed out explicitly that the safety measures of the device may be ineffective.
c. Operate the device only on smooth, horizontal surfaces. Avoid deviations with regard to temperature, drafts, direct sun light or vibrations.
These can result in incorrect measurement values measuring values.
d. In case of malfunction, stop operating Mispa i3 immediately! Prior to continuing to operate the device, read the notes concerning
cleaning, error messages and troubleshooting. After consulting the manufacturer or authorized distributor, you may ship the device for
repairs to the manufacturer or authorized distributor.
e. Use only original accessories and spare parts to avoid damage to the analyzer and to people. Repairs must only be conducted by the
manufacturer or by companies authorized by the manufacturer.
f. The use of reagents and consumption materials that are not recommended by the manufacturer can cause severe measuring errors and
malfunctions and is therefore not permissible.
g. If the user opens the device without authorization, he / she shall not be entitled to any rights concerning the liability for the device

2.5 Maintenance

The Mispa i3 needs maintenance by authorized professionals every year. Without regular maintenance, incorrect results may occur for which
the manufacturer is not liable.

For further information, please refer to the chapter Maintenance / Troubleshooting.

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3. Description of analyzer

3.1 Introduction

This chapter describes the analyzer's measuring principle, layout, and accessories, and the consumption material. This chapter will provide you
with general information. For detailed instructions and description, please refer to chapter ‘Operation’.

3.2. Intended use

The Mispa i3 is an analyzer for biochemical in-vitro diagnostics. It must only be used and operated by trained personnel. Operating the
instrument for home testing is expressly forbidden.

The sample material is taken out of a closed sample tube and is pippeted into the sample cup collected in the cartridge. The wash solution
containers for the system and waste solution collection bottle is located on the backside of the device, which are capped with separately
marked/colored stoppers including feeding hose.

It is advised that both containers must be replaced at the same time since they are adjusted to each other.

3.3 Features:

a. Measurement of various parameters of human sample material (for an overview of the parameters, please contact the manufacturer or
authorized distributor)
b. Dual channel system of Nephlometry and Photometry with high sensitivity and wide range
c. Automatic recognition of parameters using internal barcode
d. Prefilled and sealed cartridges along with sample cell for specific test
e. Hand held and inbuilt barcode for auto test detection and Patient ID entry
f. Touch screen LCD display
g. Inbuilt printer
h. User-friendly procedure for all functions
i. Patient demographic facility
j. Serial RS 232 electronic data processing interface
k. Interface for external bar code reader
l. 30 minutes’ battery backup without power from main

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 m. Fully auto pipetting
n. Voice and Visual feedback for user interaction
o. 1000 test result memory
p. Three QC level for each parameter designed for 30 days
q. Result in 4-8 min

3.4 Measuring Principle

Nephlometry is the technique for measuring the light scattering particles in the solution by means of the light intensity at an angle away from
the incident light passing through the sample. It gives more sensitivity

Turbidimetry is the measurement of light scattering in solution by means of a decrease in intensity of the incident beam after it has passed
through solution. It gives high linearity.

Mispa i3 uses both Nephlometry and Turbidimetry for analysis.

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3.5 Accessories

As described and shown in chapter 2.6, Mispa i3 is supplied with standard accessories. In addition, further optional accessories can be ordered.
Both manufacturer and authorized distributor will gladly provide information about connecting interfaces.

3.6 Consumables

To operate the analyzer, the following consumables are needed:

a. Pre-filled sample in respective test cartridge -Pack Size Special Parameters (1x10), Routine parameters (3x10)
b. Reagent cartridges with Calibration card
c. Container kit with system solution
d. Special cleaning Cartridge (To be run after 100 number of test or 30 days whichever is earlier )

For detailed instructions on how to use these consumables, please refer to the chapter ‘Operation’ of this manual

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3.7 Technical Specification

Test method Nephlometry and Photometry

Display 7” color TFT display
Light Source 650nm Laser
Weight 7.5 Kg
Laser power <5mW
Temperature control Dry heating
Temperature Controlled 37 +/- 0.2 degree Celsius
Photo detector Si Diode
Calibration Smart Card
User interface TFT display which resistive touch
Printer Inbuilt thermal graphic printer (paper with 75mm)
Barcode Reader Inbuilt barcode reader and Hand held reader (optional)

Syringe Pump 500 µL with 1µL resolution

Interface RS232 Ports (data transmission, External Barcode)
Power supply 85-265 VAC 50/60Hz
Power consumption 100W
Result Storage 500 result

Reagent All in one cartridge (with barcode label)

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4. Analyzer Functions

This chapter of the manual includes all information useful for day-to-day operation of Mispa i3.

Part 2 provides all additional information which is needed to understand functions, complementary functions and certain sources of possible
problems.

The person responsible for the device must be familiar with both parts and must also have the medical knowledge to be able to interpret the
acquired values correctly. Conclusions for diagnostics may only be drawn by a medical practitioner.

4.1 Safety instructions

As mentioned before, certain safety warnings must be followed during operation in order to guarantee correct and faultless operation:

a. The device must only be used for the described indication and must only be used and operated by trained personnel.
b. Every user is responsible for adhering to safety, health and legal regulations, and for operating Mispa i3 according to its intended use
alone.
c. Interpreting the results and diagnosis on this basis must be left to a medical practitioner. Operating the device for home testing is
expressly forbidden.
d. In daily operation, regular checks of the results should be made; if needed, an additional control measurement should be carried out.
e. Do not switch off the device or disconnect it from the power supply while it is running. If this happens, malfunctions can occur the next
time the device is switched ON.
f. If you suspect a malfunction or incorrect measuring results, please inform the person responsible for the device immediately. If necessary,
this person will contact the manufacturer or distributor to solve the problem.
g. In case of unintentional skin contact with potential infectious material, e.g. human blood samples, disinfect the affected area with a
suitable antiseptic solution.

The system solution is not corrosive, toxic or strongly skin irritating. In case of skin contact with system solution, the washing of the affected area
with water is appropriate.

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4.2 Installation Environment

Before start-up, check the supplied analyzer and accessories for completeness. If anything is missing, please contact your supplier immediately.
Furthermore, please check all parts for intactness. Proper and safe operation is only guaranteed when using original parts and accessories. Never
use damaged parts or parts from other manufacturers.

Place the Mispa i3 onto a horizontal, smooth and dry surface. Please choose a location where the instrument is protected from direct sunlight and
extreme variations in temperature since these can impair measuring results.

4.3 Installation Conditions

Location : Indoors

Operating Temperature : 15 -35-degree Celsius Operating

Humidity : 20-80 % (relative humidity)

4.4 Connecting the device to the power supply

Please make sure that the voltage mentioned on the analyzer is the same as the voltage of your power grid.

a. The device is connected to the main power supply via power cord.
b. Connect the power cord in to the power socket at the right side of the analyzer and other end to the main power plug.

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 4.5 Connecting Wash solution /Waste bottle:

a. For connecting wash solution tube from the bottle, push down the coupling body inlet which is present at the rear panel of the analyzer
and insert the hose barb in the aperture and release the coupling body.
b. For connecting waste tube from the bottle, push down the waste coupling body which is present at the rear panel of the analyzer and
insert the hose barb in the aperture and release the coupling body
c. For connecting wash solution and waste level sensor from the bottles, insert female connectors from the bottle to male connectors, which
is present at the rear panel of the analyzer and rotate in clockwise direction.

4.6 Printer and paper installation

a. Pull down the printer cover on side of the analyzer.

b. Place the paper roll in the indented area.
c. Close the printer cover, so it prints the analyzer name when analyzer switched ON

4.7 Battery Backup

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 Mispa i3 comes within built-in rechargeable battery and can operate up to 30 min without power from main power supply. Different power
status indication (On mains, on battery, 20% battery power) will display on the screens, thereby it is possible to avoid the sudden shutdown of
the analyzer.

4.8 Initial Procedure

After the analyzer has been installed as described above, the container kit with system solution must be connected to it. Proceed as follows:

a. Make sure wash solution is there in the wash solution bottle and there is no waste in the waste bottle.
b. Connect wash solution and waste bottle tubing’s along with sensors to the analyzer.
c. Insert paper roll in the printer.
d. After finishing these steps the installation of the device is completed.
e. Turn on the device by switching the "ON/OFF" switch backwards.
f. Turn on the power switch, at the back of analyzer. At the time of power up, product and company logo appears on the screen along with
current date and time.
g. Analyzer will automatically switch to self-test in initialization mode.

h. If no error is found, “SELF TEST SUCCESS” message will be shown in the screen and it will load the main screen of the analyzer
automatically.

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i. In case of warning alone, analyzer display all the warning codes along with graphical indication and one continue button. Sim ultaneously
countdown of temperature stabilization will start.
j. Select continue button to proceed the analyzer with the displayed warnings.
k. Analyzer will load and display main menu along with updated warming up count down.

l. In case of error and warning, analyzer displays all the error/warning codes with the message “SELF TEST FAILED”. And also it gives audio
message “cannot proceed”. There by analyzer cannot proceed further, so restart the analyzer by turning off and on the power switch.
Then check whether the errors are remaining in that, if error exist then contact corresponding service engineer.

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4.9 Configuring the date & time slot

a. If the date and time is not set, then analyzer will prompt “insert date & time”.
b. Enter the date and time in the specified format and select save function.
c. By selecting “home” button user can able to enter in to the main menu.

d. Once the initialization completed without any error or warning analyzer automatically enter in to warming up of 600 Sec, by loading main
screen, here temperature stabilization will take place.

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e. If the temperature is not stable after 600 secs, temperature error message will display on the screen. So restart the analyzer and check
whether the temperature errors are still remaining. If error exists, then contact corresponding service engineer.

Note: Unless the temperature is stable, access to test and QC RUN is not allowed and analyzer will display the error message
“Temperature not stable”.

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4.10 Operations : Main menu

Once the temperature stabilization accomplished, user can access any function from the main menu. Mispa i3 has seven functions. According
to the need, user can select any of these function.

4.10.1 Test

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a. To run the test selects test button from the main menu.
b. Cartridge loading screen will display & carrier will slide out.
c. Dispense the sample in sample cell of the cartridge and place the Cartridge on the carrier. Select “ok” button to proceed or Select
“Home” and exit in to main menu.

Note: Access to the test and QC run functions is not possible in wash solution empty waste bottle full and Battery mode with less
than 20% of battery power

d. Analyzer will read the barcode on the cartridge and corresponding test name will be displayed on the test details screen.
e. If cartridge is not detected analyzer exit to cartridge loading screen and the cartridge carrier will come out from the analyzer.

Note: Current date and time of the analyzer, wash solution and waste level indicator, Power status along with battery power will
display on the information bar. If CAL data in card mode analyzer will shows the card indication on the information bar.

f. If CAL data is in Card mode, and if the card is present then analyzer displays calibration data. Otherwise it will display the error message
“Please insert IC card”. If the Cal data is in analyzer mode and equivalent test Calibration is saved, then the test details will display on
the screen otherwise analyzer will display “Please insert IC Card”.
g. Once the card is detected it will display “IC card detected” & “Reading card” messages and will simultaneously display test details.
h. Analyzer will check for errors, if any error is identified, the analyzer will show the error messages

1. Lot number miss matched please insert IC Card

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 2. Card Expired insert IC Card
3. No of test left: 0 please insert IC Card

i. User can load the IC card and save.

j. Select ok button to proceed or select exit button and abort.

k. Once pressed “OK” analyzer will load the test run screen.
l. The selected test name, expiry, no of test left will be displayed on the output field of test run screen.
m. User can enter Pt Name, Pt ID (mandatory), age and sex in input field.
n. Once required data is entered, Press “START” button to run the test.

Note: Patient ID should be 10 digit and analyzer will not accept 0000000000 as patient ID while running the test

o. Make sure Pt ID is entered before pressing START if auto Pt id is off, otherwise it give the error message “please enter Pt ID”
p. To input patient ID using Ext barcode, connect Ext barcode to COM 2 of analyzer and scan the patient ID barcode while running the test &
make sure to turn on Ext Barcode ON .

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q. Status updates along with status bar and will display on the screen.
r. Analyzer will give audio message for each and every status if audio function is ON.

s. After test completion, result will display, and analyzer will print the result if auto print is ON. And it gives the audio message “Test
completed”.

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 t. Cartridge carrier will come out from the analyzer so remove the cartridge and press “Exit” button.
u. Continue the process for the next test.

Test Abort:

a. User can abort the test after starting the process

b. Select exit button, so analyzer will display the conformation message.
c. Select exit again to abort the test, so cartridge carrier will come out form the analyzer.

4.10.2 History

The analyzer is developed with inbuilt storage capacity of 1000 test result, User can review and retrieve these saved data’s through “history
“function.

a. In the history menu user will get three option.

1. Date
2. parameter
3. Patient ID.
b. After 1000th result analyzer automatically rewrites the first saved result with new result.

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 Note: User need to fill all the input field before search. And should follow this date format “DD/MM/YY” otherwise analyzer gives the
error message “invalid data”. While printing the results, access to other functions are not allowed.

4.10.2.1 Date History

a. To view the result date wise, select date function from history menu.
b. There for analyzer load the date history screen. Enter the date in the specified date format and select “OK” button.

c. Result under with respective date along with Pt ID, test name and flag will be loaded and displayed on screen along with total count.

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 d. Select the PRINT button to print the date
e. Use “up & down” button to scroll the data’s up and down
f. Select “Exit “button to exit into history main

4.10.2.2 Patient ID

a. To view the result Patient ID wise, select Patient ID function from history main.
b. There for analyzer load and display the Pt ID search screen. Enter Patient ID and selection” button.

c. Result under Patient ID along with date, test name and flag will be loaded and displayed on screen along with total count.

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 d. Select Print button to print the data.
e. Use “up & down” button to scroll the data’s up and down.
f. Select “Exit “button to exit into History main.

4.10.2.3 Parameter

a. Select Parameter function from history main. Parameter history screen will be displayed.

b. Select Parameter button

c. Analyzer will load and display parameter selection screen.
d. Select any parameter name

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 e. Selected name will be display on the parameter main screen

f. Enter From and to date in specified format and select ok button.

g. So result of this parameter with in this date limit with ID, Date and flag will be loaded and displayed along with total count.

h. Select Print button to print the data. Use “up & down” button to scroll the data’s up and down.
i. Select “Exit “button to exit into History main.
4.10.3. QC

Mispa i3 is designed with three levels of QC function.

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 a. Set up the quality control reference for each parameter using QC Setup.
b. To run the QC, select the QC run function.
c. Through selecting QC Graph, function user can see the performance graph.

4.10.3.1 QC Setup:

a. Select QC Setup from QC main

b. Analyzer load and display test name list.
c. Select any test name from the displayed test name screen or select exit and abort the function.

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 d. Select any QC level.
e. Selected test name and QC level will display on QC setup screen.
f. Enter parameters Lot No, SD, Mean and save the entered data to proceed or Select “Exit” button to exit in to QC main.

Note: Without selecting QC level user not allowed to enter or save the parameters. Without entering all the parameter user not
allowed to save any data.

4.10.3.2 QC Run

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a. To run the QC selects QC run function from the main menu.
b. Cartridge loading screen will display on the screen.
c. Dispense the sample in sample cell of the cartridge and place the Cartridge on the carrier.
d. Select “OK” button to proceed or Select “Home” and exit in to main menu.

Note: Access to the test function is not possible in wash solution empty condition and Battery mode with less than 20% of battery
power.

e. Analyzer will read the barcode on the cartridge and corresponding test name will be displayed on the test details screen.
f. If cartridge is not detected analyzer exit to cartridge loading screen and the cartridge carrier will come out from the analyzer.

Note : Current date and time of the analyzer, wash solution and waste level indicator, Power status along with battery power will
display on the information bar. If CAL data in card mode analyzer will shows the card indication on the information bar.

g. If CAL data is in Card mode, and the card is present then analyzer displays calibration data. Otherwise it will display the error message
“Please insert IC card”. If the Cal data is in analyzer mode and equivalent test Calibration is saved, then the test details will display on
the screen otherwise analyzer will display “Please insert IC Card”.
h. Once the card is detected it will display “IC card detected” & “Reading card” message and will simultaneously display test details.
i. Analyzer will check for errors, if any error is identified, the analyzer will show the error message.
1. Lot number miss matched please insert New IC Card
2. Card Expired Insert New IC Card
3. No of test left: 0 please insert New IC Card
j. User can load the IC card and save.

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k. Select ok button to proceed or select exit button and abort.

l. Therefore, analyzer will load and display QC setup screen along with selected test name.
m. Select any QC level, if the QC parameter saved then it will display the details otherwise it shows the error message “enter parameters”.
n. Select OK button to go to QC Run screen.

o. Selected test name, Expiry, no of test left, along with selected QC level and its parameters will be display.
p. Press “START” button to run the test.

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q. Status updates along with status bar will display, and the analyzer will give audio message for every status if audio function is on.

r. After test completion, result will be displayed, and analyzer will print the result if “auto print” is “ON “along with audio message “test
completed”.
s. Cartridge will come out from the analyzer.
t. Select accept button to accept the QC result or select reject and exit the function.
u. Remove the cartridge and press “Exit” button.

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 v. Do the same process for the next QC test

4.10.3.3 QC Graph

a. Select QC graph from the QC main.

b. So analyzer will load and display test name list
c. Select any test from the displayed test name screen.

d. Selected test name will be displayed on the screen.

e. Select any QC level, if QC parameter of selected test and QC level saved then it will display otherwise it show the error message “No
saved parameter”.

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 f. Select “Show” button to plot the graph or select exit and abort.
g. Analyzer will display its average, SD, CV, beyond 1SD, 2SD, and 3SD with its graph. If there are no QC run, it shows the error message will
be displayed “No result to show”.
h. Select print button to print the graph and all QC results. Or select exit and abort.

4.10.4. Setup

To enter in to analyzer setup selects “Setup” function from the main menu.

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 There by analyzer will load the setup screen with default analyzer settings

4.10.4.1 Auto PT ID

By Default, Auto Pt ID will be ON. User can turn ON or OFF the Pt ID. If its turn on auto-updating of the Pt id will be take place at the time of
test run. Otherwise user need to enter the Pt Id at the time of each test run.

4.10.1.2 Auto Print

By Default, Auto Print will be ON. User can turn ON or OFF the Auto-print, if it is turn on, the analyzer will automatically print the test
results.

4.10.4.3 External Barcode

By Default, External barcode will be OFF. And it can be turn ON or OFF, if its turn on Pt ID can be input through the external barcode.

4.10.4.4 CAL Data

User can access the calibration data either from the card or from analyzer. By Default, CAL Data will be in Analyzer mode. Toggle to card
mode to take the calibration from the card, in card mode make sure the card is inserted in to the analyzer.

4.10.4.5 DATE

Current date of the analyzer will display here.

User can set the date by toggling +/- one, of current date, and user does not have the permission to edit the month and year.

4.10.4.6 TIME

Current time of the analyzer will display here.

Note: Edit the date and time before selecting save button. Date and time editing is allowed only 5 times.

4.10.4.7 System view

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 Access to the system view is only in service mode

4.10.4.8 New Calibration

Access to the system view is only in service mode.

4.10.4.9 Speaker

It is possible to mute or adjusts the volume of speaker by changing right and left key of the function.

4.10.4.10 Audio ON/OFF

Audio can be turn on or off, if it is turned on the analyzer will produce all audio messages.

Note: If CAL Data in the analyzer mode user need to save the calibration data in to analyzer. Else, at the time of test run user can insert
and save the calibration data.

4.10.5 Maintenance

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 For the proper working of the analyzer user should run the maintenance function. During the maintenance, please follow the instruction.

a. Select maintenance button from main menu.

b. Analyzer will load and display maintenance main screen.

4.10.5.1 Prime

Priming is for the clean and refresh the liquid systems of the analyzer.

a. Select prime button from maintenance main.

b. So analyzer will start the priming and it displays the message “Priming”. At the time of priming, access to any other function is not
allowed.
c. Once priming is completed user will get the message “Priming competed”.
d. Select “Home” button and exit the function.

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 Note: Every time after refilling wash solution in the wash solution bottle, it is mandatory to do priming, so analyzer will
automatically do the priming or user may do the same to ensure proper cleaning of the machine. Analyzer will not allow priming, if
wash solution is empty in the wash solution bottle.

4.10.5.2 Restart

In maintenance, there is a facility to restart the analyzer.

a. Select “Restart” button from the maintenance main to proceed for restart.
b. Therefore, analyzer will start doing restart.
c. Once the restart function is completed the analyzer will enter in to the normal mode of operation. If there is any error or warning saying
“user cannot access the analyzer”, then please contact the service engineer.

4.10.5.3 Service

Service function is access only in service mode.

4.10.5.4 Special cleaning

Special cleaning is for the Probe and washing station to avoid the carry over.

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 a. Select the “Special cleaning” function from the maintenance menu.
b. Cartridge carrier will come out from the analyzer.
c. Load the Special cleaning cartridge for the special cleaning and select “ok” to proceed.
d. If cartridge not detected cartridge carrier will come out from the analyzer.
e. Select ok button to start the doing the special cleaning.
f. The cleaning process will begin. Once it finished indications will display on the screen. And cartridge carrier will come out from the
analyzer.
g. Remove the cartridge from the carrier and exit the function.

Note: Special Cleaning test should be performed after completing 100 test count or 30 days. User can move to the 101th test, only
after performing the special probe cleaning test. Make sure to load special cleaning cartridge ,itself not the used cartridge or
parameter test cartridge

4.10.5.5 Saved Calibration

Saved calibration function is used to retrieve Saved Calibration data in the analyzer.

a. Select “saved calibration” button from the maintenance main.

b. Saved Test names, Lot numbers, Open date, Expiry, and No of test left will be displayed on the screen.
c. Select exit button to abort the function.

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4.10.5.6 Warning error histories

The analyzer encounters the errors and warning’s while running the analyzer and corresponding error/ Warnings Code or messages will be
displayed on the screen. Select Error warning history button from maintains button.

a. Analyzer will load and display all error, warning codes along with its date
b. User may scroll up and down to view all the error, warning codes.
c. Select exit button to exit in to maintains main screen.

4.10.6 Help

Help function is for the user support.

a. Select “Help” button from the main menu.

4.10.6.1 Contact Us

Company contacts can be retrieved from contact us menu. By default, analyzer will display Company contacts.

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4.10.6.2 Guild lines

To maintain the analyzer proper way user should follow the Guild lines.

a. Select guidelines function from the Help menu.

b. Analyzer will list out all the instruction that user need to follow.
c. Select “home” button to exit in to main screen.

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4.10.6.3 Operations

This is for to direct the users for the proper running of Test and QC functions.

a. Select Operations function from the help main screen.

b. Analyzer will display Test and QC buttons.
c. Select Test function to get the operational guidance to run the test’s analyzer will load and display the details.
d. Select QC function to get the operational guidance to run the QC. So analyzer will load and display the details.
e. Select “Home” button to exit in to Main menu.

4.10.7 Shut Down

a. Select “Shutdown” button from the main menu to turn off the analyzer.
b. Select “shutdown” again to confirm the process
c. Analyzer will start the shutdown process.
d. While shutdown, if cartridge is present, the analyzer will show the error message “Remove the Cartridge from the carrier and shutdown
the analyzer”
e. Remove the cartridge from the carrier and press shutdown function

Note: While doing shutdown make sure cartridge is not present inside the analyzer. Turn off the Main power after shutting down the
analyzer.

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4.10.8 Laboratory information system

User can connect Mispa i3 to LIS

a. Connect RS232 to COM 1 of the analyser

b. LIS format : Test name | Patient ID | Result | Unit | reference range | Prozone |

5. Trouble shooting and cleaning

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 Error / Warnings Action recommended
Why Mispa i3 is not turning On? The power cable may damage. Replace with new power cable.

Why Mispa i3 is showing the error message “Self-test Error’s found as the result of self-test
Failed” along with audio message “Cannot proceed”?

Why Mispa i3 is showing the error codes “1E03” Cartridge carrier axis homing error. Restart the analyzer and check whether error
persist, if yes, contact service engineer

Why Mispa i3 is showing the error codes “1E04” Up/down probe axis homing error. Restart the analyzer and check whether error
persist, if yes, contact service engineer

Why Mispa i3 is showing the error codes “1E05” Syringe homing error. Restart the analyzer and check whether error persist, if
yes, contact service engineer

Why Mispa i3 is showing the error codes “1E06” Blank error CH1. Restart the analyzer and check whether error persist, if yes,
contact service engineer

Why Mispa i3 is showing the error codes “1E07” Blank error CH2. Restart the analyzer and check whether error persist, if yes,
contact service engineer

Why Mispa i3 is showing the warning codes “1W03” Printer not connected. Restart the analyzer and check whether error persist, if
yes, contact service engineer

Why Mispa i3 is showing the warning codes “1W04” Printer head temperature error. Restart the analyzer and check whether error
persist, if yes, contact service engineer

Why Mispa i3 is showing the warning codes “1W06” Blank warning CH1,Restart the analyzer and check whether error persist, if yes,
contact service engineer

Why Mispa i3 is showing the warning codes “1W07” Blank warning CH2,Restart the analyzer and check whether error persist, if yes,
contact service engineer

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Why Mispa i3 is showing the warning codes “1W08” Temperature warning , Restart the analyzer and check whether error persist, if
yes, contact service engineer

After self-test analyser prompt for date and time entry Analyser date and time has been reset, enter and save the date along with time
and proceed

Why Mispa i3 unit not reading the IC Card? The IC Card slot needs requires cleaning. If Service required contact
Service Engineer.

Why IC Card is not functioning properly? Insert card properly / Replace the Card. If Service required contact Service
Engineer.
Why Mispa i3 is showing the error code “1E01”/ “wash Wash solution finished in the wash solution bottle refill the wash solution and do
solution empty”? priming. / wash solution level sensor may not be connected. Connect wash
solution level sensor

Why Mispa i3 is showing the Warning code “1W01”? Battery level of the analyzer is less than 20 %. Connect to main power.

Why Mispa i3 is showing the Warning code “1E02”? Waste is full in the bottle hence remove the waste from the waste bottle. /
Waste bottle sensor may not be connected, connect waste level sensor.

Why Mispa i3 is showing the Warning code “1W05”? Paper roll finished. Replace Paper roll.

Why Cartridges not detecting while doing the test? Barcode scanner not working /cartridge loaded in wrong way / Barcode on
the cartridge may damage contact Service Engineer.
Why analyzer is showing the error message Analyzer temperature is unstable, restart the analyzer and check whether the
“Temperature not stable”? error persist, if yes, contact service Engineer.
Why analyzer is not giving sound indication and the Speaker and audio function may in mute mode / Speaker is not working.
audio messages? Contact Service Engineer.

Why analyzer is showing the warning “Please wait”? Analyzer is on process

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 Why analyzer is showing invalid data”? The data is wrong / invalid format

Why analyzer is showing the warning “Please enter the Pt Enter the Pt ID or make auto Pt ID on before starting the test run.
ID”?
Why analyzer is showing the message “Please enter all Enter all the required fields.
fields”?
Why analyzer is showing the messages “Lot number miss Replace the IC card.
matched” “Card expired” “test left: 0”?
Why analyzer is showing the messages “Turn off the Shutdown completed, turn off the main power.
power”?

6. Maintain your analyzer

Maintenance Interval Maintenance operation

Run the QC Program every day
Every day Shut down the analyzer and follow the same procedure after using analyzer.

Run Special cleaning cartridge after completing 100 test or after 30 whichever is
earlier days to avoid carry over. The analyzer will prompt for cleaning.

If the wash solution finished, do priming otherwise analyzer will automatically do

priming.
As required
If the waste full in the container, analyzer will give the indication, so remove waste
from the bottle.

To get reliable result analyzer need to work in normal status, so do restart function if
any error found then proceeds to the normal functions.

If you observe any other error message, troubleshoot the analyzer.

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7. Abbreviation

QC Quality Control
CAL DATA Calibration data
SD Standard Deviation
AVG Average
CV Coefficient of variation
MAINT Maintenance
Ext Barcode External Barcode
Pt ID Patient ID
Lot No Lot number
L Low
H High
M Medium
P Prozone

6. Do’s & Don’ts

1. Keep the analyzer in clean, dry and dust free area.

2. For the proper ventilation, keep minimum of 200 mm distance between the analyzer and wall.
3. Do not place any object in front of the cartridge carrier.
4. Keep the unit away from radiation or direct airflow (Under A/C vent).
5. Keep electromagnetic device away from the analyzer.
6. Do not use damaged power cord.
7. Don’t touch display with sharp object.
8. Before starting the test bring the cartridge to ambient temperature (25 °C).
9. Tap the cartridge gently before adding the sample.
10. Load cartridge on the carrier and dispense the sample in the sample cell of the cartridge,

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11. Dispense the sample in the sample cell, before loading the cartridge in to the analyzer.
12. Use 80uL as minimum Sample volume.
13. Don’t touch the measuring cell of the cartridge.
14. While performing the test, Load the cartridge smoothly and do not pull the rail of the analyzer.
15. Follow the display instructions while performing the tests.
16. Do not switch off the analyzer while running the test.
17. Do not Load used Cartridge
18. Do not move the wash solution and waste containers while performing test.
19. If the Battery is less than 20% then do not attempt any test. Test will not proceed if the battery is more than 20 %.
20. After finishing 100 number of test run, analyzer will request for special cleaning, Do the special cleaning and continue the test run.
21. Avoid moisture on the IC card.
22. Excess pressure on the IC Card can damage the card slot and card itself.
23. Do not insert or remove the IC Card during the test, it will damage the data provided in the IC card.
24. Run QC program every day.
25. If wash solution finished refill the wash solution and do priming.
26. Empty the waste bottle ones the warning received from the analyzer, do not allow it to overflow.
27. After the use of the analyzer, remove the cartridge, Shut down the analyzer, turn off the power, and clean if any contamination in the
analyzer.
28. Clean wash solution and waste containers before refilling wash solution and after pouring out the waste water.

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Page 51 of 52
Sharp for accuracy and smooth in procedure, open to all and no
closed loops, bright as future and simple as present

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