Mispa i3 user manual final

USER MANUAL Automated Cartridge Based SpeciďŹ c Protein Analyzer

1.1. Title

USER MANUAL

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

Manual Version: M30001 1|Page

1.2. Content Table

Contents

2.

3.

4.

1.1.

Title ................................................................................................................................................................................................................ 1

1.2.

Content Table................................................................................................................................................................................................. 2

1.3.

Preface ........................................................................................................................................................................................................... 4

Product Description ............................................................................................................................................................................................... 5 2.1.

System introduction ....................................................................................................................................................................................... 6

2.2.

Main analyzer................................................................................................................................................................................................. 6

2.3.

Prefilled and sealed cartridges along with sample cup for Specified test. .................................................................................................... 6

2.4.

Smart Card containing test details and calibration curves. ........................................................................................................................... 7

2.5.

Symbols and Terms ........................................................................................................................................................................................ 8

2.6.

List of Accessories .......................................................................................................................................................................................... 9

2.7.

Manufacture Liability and Warranty .............................................................................................................................................................. 9

Safety ................................................................................................................................................................................................................... 10 3.1.

Introduction ................................................................................................................................................................................................. 10

3.2.

Responsibility / Training of the operator ..................................................................................................................................................... 10

3.3.

General safety instructions .......................................................................................................................................................................... 11

3.4.

Product specific safety instructions ............................................................................................................................................................. 11

3.5.

Maintenance interval ................................................................................................................................................................................... 12

Description of analyzer ........................................................................................................................................................................................ 12 4.1.

Introduction ................................................................................................................................................................................................. 12

4.2.

Mispa i3 offers the following features: ........................................................................................................................................................ 13

4.3.

Measuring Principle ..................................................................................................................................................................................... 14

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5.

6.

4.4.

Accessories ................................................................................................................................................................................................... 15

4.5.

Technical Specification ................................................................................................................................................................................. 16

Introduction ......................................................................................................................................................................................................... 17 5.1.

Safety instructions ....................................................................................................................................................................................... 17

5.2.

Installation Environment.............................................................................................................................................................................. 18

5.3.

Connecting the device to the power supply: ............................................................................................................................................... 18

5.4.

Connecting Water/Waste bottle:................................................................................................................................................................. 19

5.5.

Installation Conditions ................................................................................................................................................................................. 19

5.6.

Printer and paper installation ...................................................................................................................................................................... 19

5.7.

Battery Power .............................................................................................................................................................................................. 20

5.8.

Configuring the date & time slot................................................................................................................................................................. 23

5.9.

Main menu ................................................................................................................................................................................................... 24

5.9.1.

Test ....................................................................................................................................................................................................... 25

5.9.2.

History .................................................................................................................................................................................................. 30

5.9.3.

QC ......................................................................................................................................................................................................... 36

5.9.4.

Setup .................................................................................................................................................................................................... 44

5.9.5.

Maintenance ........................................................................................................................................................................................ 47

5.9.6.

Abbreviation......................................................................................................................................................................................... 59

Do’s & Dont’s ....................................................................................................................................................................................................... 60

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1.3. Preface Congratulations on purchasing an 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

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2. Product Description 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

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Rear View

2.1. System introduction Mispa i3 Cartridge based specific protein analyzer is cosmposed of the following segement 1.3.1

Main analyzer with inbuilt printer.

1.3.2 Prefilled and sealed cartridges along with sample cup for specified test.

1.3.3 Smartcard containing test details and calibration curves.

1.3.4 Accessories.

2.2. Main analyzer a. Main 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. Barcode reader - Inbuilt and handheld barcode reader facility for the automatic test detection from the specified cartridge and for patient ID entry. d. Measurement module: A unit for measuring the intensity of the light, which comes out from the cartridge. e. Water & Waste bottle assembly meant for washing the system of analyzer. f. And In built printer, for automatically printing the test results and other details.

2.3. 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.

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2.4. Smart Card containing test details and calibration curves.

IC card contains the information related to specific test calibration graph, lot number, total number 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 inserted in the analyzer, complete data will be stored in the analyzer memory, if it is in the card mode. Or else analyzer makes use of the data from the IC card itself.

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2.5.

Symbols and Terms Sl No

Symbol /Terms 1

Description Serial Number

SN

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2

Reference Number

3

Attention

3

Consult instructions for use

4

Manufacturer

5

Biohazards warning

6 7 7

COM 1 COM 2 Water

Communication port 1 Communication port 2 For connecting water bottle (Tube and sensor)

8

waste

For connecting waste bottle (Tube and sensor)

2.6. List of Accessories Designation

Quantity

Mispa i3

1

Power connection cable

1

Operator’s manual

1

Final Check Report

1

Waste & Water bottle along with tubing’s & connectors

1

Waste & Water bottle stand

1

Pipette 20-200 µL

1

2.7. Manufacture Liability and Warranty Legal liability and warranty claims are expressly excluded in the following cases: - gross negligence or willful damage of the device, parts thereof or consumption material - unauthorized opening of the device by untrained personnel (without proper service training) - force majeure (e.g. stroke of lightning, water damage, fire) - 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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3. Safety 3.1. 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 release the person operating the device from adhering to the safety measures of the facility.

3.2. Responsibility / Training of the operator   

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.

Every user is responsible for adhering to safety, health, and legal regulations, and operating the device only according to its intended use.

Interpreting the results and diagnosing on that basis must be left to a medical practitioner. Operating the device for home testing is expressly forbidden.

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3.3.  

   

General safety instructions 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.

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.

In case of unintentional skin contact with potential infectious material, e.g. Human blood/Urine samples disinfect the place concerned 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 concerned place with water is appropriate.

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.

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.

3.4. Product specific safety instructions       

The device may only be used for the intended use with special attention to the defined usage restrictions and constraints to be strictly adhered to (in case of need contact the manufacturer).

In case of not intended use, it is pointed out explicitly that the safety measures of the device may be ineffective.

Operate the device only on smooth, horizontal surfaces. Avoid deviations with regard to temperature, drafts, direct sun light or vibrations. These can result in faulty measuring values.

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.

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.

The use of reagents and consumption materials that are not expressly recommended by the manufacturer can cause severe measuring errors and malfunctions and is therefore not permissible.

If the user opens the device without authorization, he shall not be entitled to any rights concerning the liability for the device

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3.5. Maintenance interval The Mispa i3 needs maintenance by authorized professionals every year, without regular maintenance, false measuring results may occur for which the manufacturer is not liable.

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

4. Description of analyzer 4.1. 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 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.

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 water 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 advice that both containers must be replaced at the same time since they are adjusted to each other.

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4.2. Mispa i3 offers the following features:                 

Measurement of various parameters of human sample material (for an overview of the parameters, please contact the manufacturer or authorized distributor).

Dual channel system of Nephilometry and Photometry with high sensitivity and wide range.

Automatic recognition of parameters using a barcode.

Prefilled and sealed cartridges along with sample cell for specific test.

Hand held and inbuilt barcode for auto test detection and Patient ID entry.

Touch screen LCD display.

Inbuilt printer .

User-friendly procedure for all functions.

Patient demographic facility.

Serial RS 232 electronic data processing interface.

Interface for external bar code reader (optional).

30 minutes battery backup without power from main.

Fully auto pipeting.

Voice and Visual feedback for user interaction.

1000 test result memory.

Three QC level for each parameter designed for 30 days.

Result in 5-8 min.

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4.3. Measuring Principle Nephelometry 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 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.

Mispa i3uses both Nephelometry and Turbidimetry for analysis thus giving high linearity (using Nephelometry) and Sensitivity

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4.4. 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.

3.5.Consumables To operate the analyzer, the following consumables are needed:    

Pre-filled sample in respective test cartridge -Pack Size special Parameters (1x10) , Routine parameters (3x10) Reagent cartridges with Caliberation card Containerkit with system solution Special cleaning Cartridge ( To be run after every 10 test)

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

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4.5. Technical Specification Test method Display Light Source Weight Laser power Temperature control Temperature Photo detector Calibration User interface Printer Barcode Reader

Nephelometry and Photometry 7” colour TFT display 650nm Laser 7.5 Kg <5mW Dry heating Controlled 37 +/- 0.2 degree celsius Si Diode Smart Card TFT display which resistive touch Inbuilt thermal graphic printer (paper with 75mm) Inbuilt barcode reader and Hand held reader (optional)

Syringe Pump Interface Power supply

500 µL with 1µL resolution RS232 Ports ( data transmission,External Barcode) 85-265 VAC 50/60Hz

Power consumption

100W

Result Storage

500 result

Reagent

All in one cartridge (with barcode label)

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5. Introduction This part of the operator’s 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 a therapy may only be drawn by a medical practitioner.

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

The device must only be used for the described indication and must only be used and operated by trained personnel.

Every user is responsible for adhering to safety, health and legal regulations, and for operating Mispa i3 according to its intended use alone.

Interpreting the results and diagnosis on this basis must be left to a medical practitioner. Operating the device for home testing is expressly forbidden.

In daily operation, regular checks of the results should be made; if needed, an additional control measurement should be carried out.

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.

If you suspect a malfunction or faulty 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.

In case of unintentional skin contact with potential infectious material, e.g. human blood samples, disinfect the place concerned with a suitable antiseptic solution.

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ď&#x201A;ˇ

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

5.2. 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.

5.3. Connecting the device to the power supply: Please make sure that the voltage noted on the analyzer is the same as the voltage of your power grid. ď&#x201A;ˇ ď&#x201A;ˇ

The device is connected to the main power supply via powe cord.

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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5.4. Connecting Water/Waste bottle: ď&#x201A;ˇ

For connecting water tubefrom the bottle, push down the water 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.

ď&#x201A;ˇ

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

ď&#x201A;ˇ

For Connect water and waste level sensor from the bottles,insert female connectors from the bottle to male connectors,which present at the rear panel of the analyzer and rotate in clockwise direction.

5.5. Installation Conditions Location :Indoors Operating Temperature :15 -35 degree cels Operating Humidity

:20-80 % (relative humidity)

5.6. Printer and paper installation a) Pull down the printer cover on side of the anlayzer. b) Place the paper roll in the indented area. c) Close the printer cover, so it prints the analyzer name when analyzer truning on.

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5.7. Battery Power Mispa i3 comes within builtin rechargeable battery and can operate up to 30 min without power from main’s.Different power indication will display on the screens,there by it is possible to avoid the sudden shutdown of the analyzer.

5.6 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:   

Make sure water is there in the water bottle and there is no waste water in the waste bottle.

Connect water and waste bottle tubings along with sensors to the analyzer. Please refer to 5.2.

Insert aper roll in the printer.please refer to 5.4

After finishing these steps the installation of the device is completed. Turn on the device by switching the "ON/OFF" switch backwards.

Note :Initialization may take up to 600 seconds. 

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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.

Figure : The Initializing screen  

Analyzer will automatically switch to self test in initialization mode.

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.

Fig : The Self test   21 | P a g e

In case of warning, analyzer display all the warning codes along with graphical indication and one blinking continue button.Simultaneously countdown of temperature stabilization will start.

Select continue button to proceed the analyzer with the displayed warnings.



Therefore anlyzer will load and display main menu along with updated warming up count down.

Fig :Self test with Warnings 

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 truning off and on the power switch.Then check whether the errors are remain in that, if error exist then contact corresponding service engineer.

Fig : Self test failed condition 22 | P a g e

5.8. Configuring the date & time slot   

If the date and time is not set, then analyzer will prompt “insert date & time”.

Enter the date and time in the secified format and select save function.

By selecting “home” button user can able to enter in to the main menu.

Fig : 5.6.5 Date and time setting 

Ones the intialization completed with out any error or warning anlayzer automatically enter in to warming up of 600 Sec,by loading main screen,here temperature stabilization will taken place.

Fig : The warm up screen 23 | P a g e



If the temperature is not stable after 600 sec,temperature error message will display on the sreen.so restart the analyzer and check whether the temperature errors are remain in that, if error exist then contact corresponding service engineer.

Figure : The unstable temperature

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

5.9. Main menu 

Ones the temperature stabilization accomplished,user can acces any function from the main menu. (Fig : 5.7.1)

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



Mispa i3 has six functions 5.9.1 Test 5.9.2 History 5.9.3 QC 5.9.4 Setup 5.9.5 Maintain 5.9.6 Help According to the user need they can select any of these function.

Fig : The main menu

5.9.1.  

Test

To run the test selects test button from the main menu.

Cartridge loading screen will display on the screen.

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

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 runfunctions is not possible in water bottle empty and Battery mode with less than 20% of battery power.

Figure : Cartridge loading screen  

Analyzer will read the barcode on the cartridge and corresponding test namewill be displayed on the test details screen.

If catridge is not detected analyzer exit to cartridge loading screen and the cartridge carrier will comes out from the analyzer.

Note Current date and time of the analyzer, water 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.

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  

 

If CAL data is in Card mode, and if the card is present then analyzer displayescalibration data. Otherwise it will display the error message “ Pease 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 otherwiseanalyzerwill display “Please insert IC Card”.( Fig : 5.7.3) Ones the card is detected it will display “ IC card detected”& “ Reading card” messages and will simultaneously display test details.

Analyzer will check for errrors,If any error is identified, the nanlayzer will show the error messages 1. Lot number miss matched please insert IC Card 2. Card Expired insert IC Card 3. No of test left : 0 Please insert IC Card User can load the IC card and save.

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

Fig : Test Details    

Once pressed “OK” analyzer will load the test run screen.

The Selected test name,expiry,No of test left will be displayed on the output field of test run screen.

User can enter Pt Name,Pt ID (mandatory),age and sex in input field.

Once required data is entered, Press “START” button to run the test.

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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”

Fig: Test run screen  

Status updates along with status bar and will display on the screen.

Aanalyzer will give audio message for each and every status if audio function is ON.

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Fig : Status updates 

After test complesion,result will display,and analyzer will print the result if auto print is ON.and it give the audio message “Test completed”. (Fig : 5.7.6).

Fig : Test result 29 | P a g e

 

Cartridge carrierwill come out from the analyzer so remove the cartridge and press “Exit” button.

Continute the process for the next test.

Test Abort :   

User can abort the test after starting the process Select exit button, so analyzer will display the confromation message.

Select exit again to abort the test, so catridge carrier will come out form the analyzer.

5.9.2.

History

The analyzer is developed with inbuit storage capacity of 500 test result,User can review and retrive these saved datas through “history”function. 



In the history menu user will get three option.

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

Figure : History Main menu

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Note: User need to fill all the input field befor search.

Should follow this date format “DD/MM/YY” otherwise analyzer gives the error message “ invalid data”.

While Printing the results, access to other functions is not allowd.

Date History  

To view the result date wise,select date function from history menu.

There for analyzer load the date history screen. Enter the date in the specified date format and select “ok” button.

Fig :Date history screen 

Result under with respective date along with Pt Id,test nameand flag will be loaded and dispalyed on screen along with total count.

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Fig : Date history result   

Select Print button to print the data.

Use “up & down” button to scrole the data’s up and down. select “Exit”button to exit into history main.

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Patient ID  

To view the result Patient ID wise,select Patient ID function from history main.

There for analyzer load and display the Pt ID search screen.Enter Patient ID and select“ok” button.( Fig : 5.7.10).

Fig : Pt ID history screen 

There for result under this Patient ID along with date,test name and flag will be loaded and dispalyed on screen along with total count.

Fig : Pt ID history result 33 | P a g e

  

Select Print button to print the data.

Use “up & down” button to scrole the data’s up and down. select “Exit”button to exit into History main.

Parameter 

To view the result in Parameter wise,select Parameter function from history main.Therefore parameter history screen will display.

Fig: Parameter history screen    

Select Parameter button.

Analyzer will load and display parameter selection screen.

Select any parameter name.

Seelected name will be display on the parameter main screen

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Fig : Parameter section  

Enter From and To date in specifed format and select ok button.

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

(Fig : 5.7.14)

Fig : Parameter history result  

Select Print button to print the data.use “up & down” button to scrole the data’s up and down. select “Exit”button to exit into History main.

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5.9.3.    

QC

Mispa i3is designed with three levels of QC function.

Set up the quality control reference for each parameter using QC Setup.

To run the QC, select the QC run function.

Through selecting QC Graph, function user can see the performance graph.

Fig : Qc main menu

QC Setup:    

Select QC Setup from QC main.

Analyzer load and display test name list.

Select any test name or select exit and abort the function.

Select any test name from the displayed test name screen or select exit and abort the function.

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Fig : Test selection for Qc setup

  

Select any QC level.

Selected test name and QC level will display on QC setup screen.

Enter parameters Lot No, SD, Mean and save the entered data to proceed or Select “Exit” button to exit in to QC main.

Fig : QC setup screen

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Note: Without selecting QC level user not allowed to enter or save the paramters.

Without enterning all the parameter user not allowed to save any data.

QC Run    

To run the QC selects QC run function from the main menu.

Cartridge loading screen will display on the screen.

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 function is not possible in water bottle empty condition and Battery mode with less than 20% of battery power.

Fig :Cartridge loading screen  

Analyzer will read the barcode on the cartridge and corresponding test namewill be displayed on the test details screen.

If catridge is not detected analyzer exit to cartridge loading screen and the cartridge carrier will comes out from the analyzer.

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Note Current date and time of the analyzer, water 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. 

 

 

If CAL data is in Card mode, and the card is present then analyzer displayescalibration data. Otherwise it will display the error message “Pleaseinsert 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 otherwiseanalyzerwill display “Please insert IC Card”.

Ones the card is detected it will display “ IC card detected”& “ Reading card” message and will simultaneously display test details.

Analyzer will check for errrors,If any error is identified, the nanlayzer will show the error message.

1. Lot number miss matched please insert New IC Card 2. Card Expired insert New IC Card 3. Noof test left :0 Please insert New IC Card User can load the IC card and save.

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

Fig : Test details

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  

Therefore, analyzer will load and display QC setup screen along with selected test name.

Select any QC level, if the QC parameter saved then it will display the details otherwise it show the error message “enter parameters”.

Select OK button to go to QC Run screen.

Fig: QC reference screen  

Selected test name,Expiry,No of test left, along with selected QC level and its parameters will be display.

Press “START” button to run the test.

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Fig : Qc run screen ď&#x201A;ˇ

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

Fig Qc Result

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    

After test complesion,result will be displayed ,and analyzer will print the result if “auto print” is “ON”along with audio message “test completed”.

Cartridge will come out from the analyzer.

Select accept button to accept the Qc result or select reject and exit the function.

Remove the cartridge and press “Exit” button.

Do the same process for the next QC test.

QC Graph   

Select QC graph from the QC main.

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

Fig : Test selection screen  

Selected test name will be displayed on the screen.

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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Fig : QC reference screen   

Select “Show” button to plot the graph or select exit and abort.

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”.

Select print button to print the graph and all QC results. Or select exit and abort.

Fig : QC Grap

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5.9.4.

Setup

To enter in to analyzer setup selects â&#x20AC;&#x153;Setupâ&#x20AC;? function from the main menu.

There by analyzer will load the setup screen with default analyzer settings (Fig: 5.7.26).

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.

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.

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.

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.

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 TIME Current time of the analyzer will display here.

Enter the date in specified format and select save button.

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Note Edit the date and time before selecting save button.

Date and time editing is allowed only 5 times.

SYSTEM VIEW  

Select system view function from the setup main. Analyzer will display the system view screen All software and hardware version along with serial no of the analyzer will be displayed.

Fig : System view NEW CALIBRTION User can load the calibration in to the analyzer using this function.    45 | P a g e

Select icon (New Calibration) from the setup menu.

Analyzer promote “Please insert IC card” So insert the IC card, so it will read and show the calibration details

ď&#x201A;ˇ

Select save button to save the calibration or select exit and abort the function.

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

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

Fig: Setup screen

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.

ď&#x201A;ˇ

Select exit button and exit in to main menu.

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5.9.5.

Maintenance

For the proper working of the analyzer user should run the maintenance function.

During the maintenance, please follow the instruction.

Note: Warning/Error History and Service functions, acces is only in service mode.

ď&#x201A;ˇ ď&#x201A;ˇ

Select maintenance button from main menu.

Analyzer will load and display maintenance main screen. (

Fig : Maintenance Menu

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Prime Note Do the priming after every refilling of water in the water bottle.

At the time of priming access to any other function is disabled.

Analyzer will not allow doing the priming if water is not present in the bottle.

Priming is for the cleaning of liquid systems of the analyzer.    

Select prime button from maintenance main.

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.

Ones priming is completed user will get the message “Priming competed”.

Select “Home” button and exit the function.

Fig : Prime Function 48 | P a g e

Restart In maintenance, there is a facility to restart the analyzer.  Select “Restart” button from the maintenance main to proceed for restart.  Therefore, analyzer will start doing restart.  Ones the restart function is completed the analyzer will enter in to the normal mode of operation. If there is any error or warning user cannot access to the analyzer operation.*Please contact the service team.

E.3) Service Service function is access only in service mode.

E.4) special cleaning Special cleaning is for the Probe and washing station to avoid the carry over.

Note User need to do the special cleaning after complaining 10 number of test. Without doing the special cleaning user will not allow doing the normal test.

Make sure to load special cleaning cartridge itself, should not load used cartridge.

    

Select the “Special cleaning” function from the maintenance menu.

Cartridge carrier will comes out from the analyzer.

Load the Special cleaning cartridge for the special cleaning and select “ok” to proceed.

If cartridge not detected cartridge carrier will comes out from the analyzer.

Select ok button to start the doing the special cleaning.

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 

The cleaning process will begin. Ones it finished indications will display on the screen. And cartridge carrier will comes out from the analyzer.

Remove the cartridge from the carrier and exit the function.

E. 5) Saved Calibration Saved calibration function is used to retrieve Saved Calibration data in the analyzer   

Select “saved calibration” button from the maintenance main.

Saved Test names, Lot numbers, Open date, Expiry, and No of test left will be displayed on the screen.

Select exit button to abort the function.

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Help Help function is for the user support. 

Select“Help”button from the main menu.

Contact Us Company contacts can be retrived from contact us menu.By default analyzer will dislay Company contacts.

Fig : Company contact screen

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

Select guidelines function from the Help menu.

Anlyzer will list out all the instruction that user need to follow.

Select “home” button to exit in to main screen.

Fig : Guidelines

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Operations This is for to direct the users for the proper runing of Test and QC funtions.     

Select Operations function from the help main screen.

Anlyzer will display Test and QC buttons. (Fig : 5.7.35) Select Test function to get the operational guidence to run the test.So analyzer will load and display the details.

Select QC function to get the operational guidence to run the QC.So analyzer will load and display the details.

Select “Home” button to exit in to Main menu.

Fig : Operation

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Shut Dwon Note While doing shutdwon make sure cartridge is not present inside the analyzer.

Trun off the Main power after shutting down the analyzer.    

Select “Shutdown” button from the main menu to turn off the analyzer.

Anlyzer will start the shut down process.

While shutdwon if cartrdige present, the analyzer will prompt the error message “Remove the Cartridgeand shutdown the analyzer” ( Fig : 5.7.36 ) Remove the cartridgefrom the carrier and press shutdown function

Fig : Operation  

Fig : Turn off message

So analyzer will start the function.After shutdown process is completed the analyzer will displayes the message “Turn off the power Switch ”.

So trun off the Power switch.

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6) Warning, Error messages The analyzer encountes the errorâ&#x20AC;&#x2122;s and warningâ&#x20AC;&#x2122;s while runing the analyzer and correspondig error/ Warnings Code or messages will be displayed on the screen.

Note If error any error found restart the machine and check any error persists after restarting, If so please contact service engineer.

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7) Trouble shooting and cleaning

Error / Warnings

Action recomended

Why Mispa i3 is not turning On?

The power cable may damaged.Replace with new power cable.

Why Mispa i3 is showing the error message “Self test Failed” along with audio message “Can not procced” ?

Error’s found as the result of self test

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?

Why Mispa i3 is showing the error code “1E02”/ “Water bottle empty”?

Insert card proerley / Replace the Card.If Service required contact Service Engineer.

Water finished in the water bottle refill the water and do priming. / Water level sensor may not be connected. Connect water level sensor

Why Mispa i3 is showing the Warningr code “1W01”?

Battery level of the analyzer is less than 20 %. Connect to main power.

Why Mispa i3 is showing the Warningr code “1W02”?

Waste water is full in the bottle hence remove the waste water from the waste bottle. / Waste bottle sensor may not be connected , connect waste level sensor.

Why Mispa i3 is showing the Warningr code “1W05”?

Paper roll finished.replace Paper roll.

Why Cartridgeis not detecting while doing the test?

Barcode scanner not working / Barcode on the cartridge may damaged contact Service Engineer.

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Why analyzer is showing the error message “Temperature not stable” ?

Analyzer temperature is unstable, restart the analyzer and check whether the error persist, if it’s there contact service Engineer.

Why analyzer is not giving sound indication and the audio messages ?

Why analyzer is showing the warning “Please wait” ?

Why analyzer is showing invaild data” ?

Why analyzer is showing the warning “Please enter the Pt ID” ?

Why analyzer is showing the message “ Please enter all fields” ?

Why anlyzer is showing the messages “ Lot number miss mateced” “Card expired” “test left : 0” ?

Why anlyzer is showing the messages “Trun off the power” ?

Speaker and audio function may in mute mode / Speaker is not working. contact Service Engineer.

Anlyzer is on procee The data is wrong / invalid format Enter the Pt ID or make auto Pt ID on before starting the test run.

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Enter all the required fields.

Replace the IC card.

Shutdown completed , trun off the main power.

Maintain your analyzer

Maintenance Interval Every day

As required

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Maintenance operation  

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



Run Special cleaning cartridge after every 10 test to avoid carry over. The analyzer will prompt for cleaning.



If the water finished, analyzer will give the indication so refill the bottle with water and do prime.



If the waste full, analyzer will give the indication, so remove waste water from the bottle.



To get reliable result analyzer need to work in normal status, so do selftest (restart).



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

5.9.6.

Abbreviation QC CAL DATA SD AVG MAINT Ext Barcode Pt ID Lot No L H M P

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Quality Control Calibration Data Standard Deviation Average Maintenance External Barcode Patient ID Lot Number Low High Medium Prozone

6. Do’s & Dont’s 

Keep the analyzer in clean dry and dust free area.



Follow the display while operating the analyzer.



Don’t not touch the measuring cell of the cartridge.



Do not use damaged power cord.



While Switching off the analyzer make sure that there is no IC Card and Cartridge inside.



Do not Switch off the analyzer while runing the test.



Do not insert or remove the IC Card during the test,it will damage the data provided in the card.



Excess pressure on the IC Card can damage the card slot and card itself.



Avoid moisture on the card.



Follow the display while performing the tests.



Do not load used cartridge.



Load the cartridge smoothly and do not pull the rail of the analyzer.



Trun off the main power after completing shutdown.

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