Mispa Plus User Manual

Advanced Semi Automated Clinical Chemistry Analyser
-1
MISPA PLUS
Dear Customers,
Greetings from AGAPPE DIAGNOSTICS LIMITED!
We acknowledge your patronage to AGAPPE’s quality

by allowing us to serve you through MISPA PLUS, a
semi-automated clinical chemistry analyzer. Your
decision of choosing AGAPPE over other options has
honoured us and we would like to assure you for best
of our services during the entire process of
installation, training and post sales service.
With more than two decades of our service to

mankind through esteemed customers like you,
AGAPPE is recognised for its strong R&D and
manufacturing facility. We follow stringent quality
standards at every stage of its manufacturing and
ensure that when the product reach to our customers
in more than 60 countries, they feel proud of their
decision for choosing us over the several choices
available for them. The robust working of the product
will help you serving your customers efficiently with
assured world class quality.
Our toll free Customer Support number can be

reached by you during the working hours and you will
be assisted by dedicated, qualified and talented team.
Our MISPA CARE team with fleet of Service

Engineers and Product Specialists will continue to
take care of the product through timely attending the
preventive maintenance. The team will promptly
reach to you during the warranty period and
thereafter during the annual contract period and will
ensure shortest downtime while serving the product
at your doorsteps.
We have more than 24000 satisfied customers, who

have experienced AGAPPE products and services.
Most of the customers have chosen AGAPPE
products repeatedly because of their past experience.
We continue to add such satisfied customers daily by
ensuring “Customer delight as our prime Motto” by
providing CUSTOMER CARE with a Difference.
We thank you for giving us an opportunity to serve

you and look forward for everlasting association with
you.
Yours truly,
Agappe Diagnostics Ltd., Cochin.

0
MISPA PLUS
Advanced Semi Automated Clinical Chemistry Analyser
ENGINEERING EXCELLENCE
CASTING TRUST
EXPERTISE THROUGH EXPERIENCE & INNOVATION

Mispa Plus is an elegant mix of Cutting-Edge technology, Innovation and Heritage. It is equipped with
state-of-the-art Penta Lens Photometry system designed to deliver high accuracy and ease of use.
Delivering quality is our priority. Powering the potential, Mispa Plus offers best performance to
laboratories looking for highest efficiency with optimal operational cost.
PACKING LIST
Item /x Item /x Item /x Item /x
Operation Manual (1 No.) Pipette Holder (1 No.) Print Roll (2 Nos.) Power Cord (1 No.)
Installation Report
Warranty Card (1 No.) Pipette (100-1000µl) (1 Pipette (5 - 50µl) (1 No.)
(1No.)
No.)
External power supply Waste Bottle with Float sensor (1No.)

DC 24V, 120W (1Nos) holding clamp (1No.)
Prepared by: Prepared by:

Signature: Signature:
Date: Date:
1
MISPA PLUS
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Forwards
1. Intellectual Property
AGAPPE Diagnostics Ltd owns the intellectual property right to this AGAPPE product and
this manual. This manual may refer to information protected by copyright or patents and
does not convey any license under the patent rights or copyright of AGAPPE or of others.
AGAPPE intends to maintain the contents of this manual as confidential information.
2. Safety Precautions
• The Analyser must be free of obstruction.

• Should not place any open liquid container, flammable material nearer to the analyser.
• Use only the provided power cord with the equipment.
• Do not touch the Power supply and its accessories with wet hand.
• When plugging or unplugging the power cord, hold the end of the power plug with dry
hand.
• If any strange sound, burning smell of smoke comes out of the power adapter or the
analyser, immediately turn off the main power supply, unplug the power cord from the
outlet and report to the concerned service engineer or to Agappe customer Service
department.
• For long term storage of the analyser, make sure analyser is turned off.
• Don’t disassemble, repair and modify the analyser in the absence of concerned service
engineer
• If the analyser falls on the floor or gets damaged, immediately turn off the power,
unplug the power cord and report to the concerned service engineer or to Agappe
customer Service department.
3. Caution for Biohazard Management

• Human sample and the material used for collecting samples should be treated as
potential biohazards and one should take care while handling clinical samples.
• User should wear protective clothing and should not let the sample, reagent and
collecting tool to be in touch with the mouth, eyes, mucus membrane or area where
the skin is cut or exposed.
• In case the clinical sample gets in contact with the skin, follow the standard laboratory
safety procedures.
• Dispose the waste water according to the local and national safety guidelines.
Precautions on Use
• Intended Use: The analyser designed for in-vitro quantitative determination of clinical
chemistry in serum, plasma, urine and CSF. Consult the company, if user wants to use
the machine for any other purpose.
• Operator: The analyser is to be operated only by professionals, doctors trained by our
company or our authorized distributors.
• Environment: Please install and operate the analyser in an environment specified in
the manual. Otherwise, it may lead to damage to analyser or it can create unreliable
result.
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4. Warranty
Agappe guarantees that all its instruments are free from manufacturing defects or faults.
Agappe undertake to repair or substitute free of charge any part, which may be found to
have manufacturing defects.
Warranty Conditions
• Such parts of the instruments that may have defects due to materials or manufacturing
defects will be repaired or substituted free of charge.
• The warranty does not cover those parts that are subject to normal wear and tear and
which are normally changed from time to time during maintenance procedure of the
instrument.
• Repairs and interventions carried out during the period of the warranty do not extend
or renew said period of warranty. The repairs of the instrument will be carried out by
authorized technician on request by the customer to the company.
Termination of Warranty
This warranty shall be terminated at the end of the warranty period and in the following
cases:
• Where attempts to make repairs or alternations have been made by unauthorized
person and/or with spare parts, which are not originals.
• Alternations have been made to the serial number of the product or of the certificate.
• The instrument is transferred to a new location without prior written approval from
Agappe.
Elements not covered by warranty
The following damages and faults are not covered by warranty.
• Damage derived from insufficient electric circuit
• Breakdown caused by imprudence
• Damage caused by force majeure such as fire and earthquake
• Consumable items such as fuses, lamps, all tubing etc. are not covered
5. Customer service department
Manufacturer Agappe Diagnostics Ltd

Address: Agappe Hills, Pattimattom (PO), District Ernakulum,
Kerala – 683562, India
TEL: +91484 2867000
FAX: +914842689666
Toll Free No.: 1800 425 7151
E-mail Address: customersupport@agappe.in
Website: www.agappe.com
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TABLE OF CONTENTS
Forwards............................................................................................................ 2
1. Intellectual Property ........................................................................................ 2
2. Safety Precautions ........................................................................................... 2
3. Caution for Biohazard Management ....................................................................... 2
4. Warranty ...................................................................................................... 3
5. Customer service department.............................................................................. 3
1 Overview ..................................................................................................... 7
1.1 Introduction............................................................................................. 7
1.2 Features ................................................................................................. 8
1.3 Specifications ........................................................................................... 9
2 Installation ................................................................................................. 10
2.1 Unpacking and Installation ......................................................................... 10
2.2 Installation Environment ............................................................................ 10
2.3 Printer and paper installation ...................................................................... 10
2.4 Power supply connection ........................................................................... 11
2.5 Connecting waste bottle ............................................................................ 12
2.6 Test trial .............................................................................................. 13
3 Basic Operating Instructions ............................................................................ 13
3.1 How to aspirate liquid ............................................................................... 13
3.2 Instructions for the correct aspiration ............................................................ 13
3.3 Reset and Turn off ................................................................................... 13
3.4 Automatic display sleep function .................................................................. 13
3.5 Common icons in all screens ....................................................................... 14
4 Analyser Settings and Functions ....................................................................... 15
4.1 Start Up ............................................................................................... 15
4.2 Home .................................................................................................. 16
4.3 Test .................................................................................................... 17
4.3.1 Test List ......................................................................................... 17
4.3.2 Begin test ....................................................................................... 18
4.3.3 Quality Check ................................................................................... 20
4.3.4 Program test .................................................................................... 22
4.4 Maintenance .......................................................................................... 26
4.4.1 General .......................................................................................... 26
4.4.2 Temperature .................................................................................... 27
4.4.3 Pump Calibration ............................................................................... 27
4.5 Absorbance ........................................................................................... 28
4.6 History ................................................................................................. 29
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4.7 Help .................................................................................................... 31

5 Maintenance ............................................................................................... 32
5.1 Wash ................................................................................................... 32
5.2 Daily Maintenance ................................................................................... 32
5.3 Periodical Maintenance ............................................................................. 32
6 Messages .................................................................................................... 33
6.1 Error Messages ........................................................................................ 33
6.2 Warning Messages .................................................................................... 33
7 Abbreviations .............................................................................................. 34
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LIST OF FIGURES
Figure 1-1 Front View of Mispa Plus ........................................................................... 7

Figure 1-2 Rear view of Mispa Plus ............................................................................ 8
Figure 2-1 Printer and paper installation ................................................................... 11
Figure 2-2 Connecting to the power ......................................................................... 11
Figure 2-3 Connecting Waste Bottle ......................................................................... 12
Figure 4-1 Start Up screen .................................................................................... 15
Figure 4-2 Temperature Stabilization screen .............................................................. 15
Figure 4-3 Home screen ....................................................................................... 16
Figure 4-4 Test screen ......................................................................................... 17
Figure 4-5 Test Screen – Begin Test ......................................................................... 17
Figure 4-6 Test with fixed factor ............................................................................ 18
Figure 4-7 Test with single standard ........................................................................ 18
Figure 4-8 Test with multi standard ......................................................................... 19
Figure 4-9 Quality check Screen ............................................................................. 20
Figure 4-10 QC Run Screen .................................................................................... 20
Figure 4-11 QC History Screen ................................................................................ 21
Figure 4-12 QC Set Up Screen ................................................................................. 21
Figure 4-13 Program Test screen - General ................................................................. 22
Figure 4-14 Program Test screen – Result ................................................................... 22
Figure 4-15 Program Test screen - Time ..................................................................... 23
Figure 4-16 Program Test screen - Calibration ............................................................. 23
Figure 4-17 Program Test screen - Calibration ............................................................. 24
Figure 4-18 Program Test screen - Reference .............................................................. 24
Figure 4-19 Program Test screen – Reference Parameters ................................................ 25
Figure 4-20 Program Test screen - Miscellaneous .......................................................... 25
Figure 4-21 Maintenance Screen .............................................................................. 26
Figure 4-22 Maintenance Screen - General .................................................................. 26
Figure 4-23 Maintenance Screen - Temperature ............................................................ 27
Figure 4-24 Maintenance Screen – Pump Calibration....................................................... 27
Figure 4-25 Absorbance Screen ............................................................................... 28
Figure 4-26 Absorbance Screen – ABS Settings .............................................................. 29
Figure 4-27 History Screen ..................................................................................... 29
Figure 4-28 History Screen – Test list page .................................................................. 30
Figure 4-29 History Screen – Test Result ..................................................................... 30
Figure 4-30 Help Screen ........................................................................................ 31
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1. Overview
1.1 Introduction
The Mispa Plus, true semi-automated clinical chemistry analyser is a symbol of superior
technology and convenience, designed to deliver high accuracy, quality results with
least turnaround time and low maintenance.
Mispa Plus, a technically superior semi-automated analyser which ensures consistent accuracy
and convenience to the user. Because of the embedded system, the equipment can switch off
while at any menu or at any stage. Mispa Plus comes with 7-inch TFT colour display with
capacitive touch screen for user friendly operation. Also, Mispa Plus provides USB and
Ethernet connectivity options to the user.
Mispa Plus gives convenient option to work through your computer facilitating convenience in
programming, sample testing, QC analysis, reporting etc.
Figure 1-1 Front View of Mispa Plus
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Figure 1-2 Rear view of Mispa Plus
1.2 Features
• It can perform End Point, Kinetic, Fixed time and Multi standard assays.
• 7-inch TFT colour display with capacitive touch screen for user friendly operation of
the analyser.
• Integrated pump and flow cell.
• Ethernet and USB connectivity.

• Internal pre-adjusted Peltier element at 25˚C, 30˚C and 37˚C.
• 18 µL flow cell volume.
• Minimum Aspiration volume, only 250 µL (0.25 mL) per test.
• The convenient option to work through your PC
• 300 programmable tests.
• Below 1% carry over with 500uL of Aspirated sample
• Built in calibration history.
• Help function key.
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1.3 Specifications
Heads Specifications
Dimension(mm) 450 x 350 x 385 (LXWXH)
Weight 9.7 Kg
Graphic display 7 inches with capacitive touch
Patient name length 24 Characters
Maximum t e s t r e s u l t storage 5000 test results
capacity
Light source Halogen lamp 12V /20W
Photo detector Silicon photodiode (range 300-1000nm)
Minimum Aspiration Volume 250 µL
Interface USB and ETHERNET
Spectral Range 340-630nm
Wave-length selection Automatic, via 8-position filter wheel. 6 standard
interference filter-340nm, 405nm, 505nm, 546nm,
578nm, 630nm.
Provision for optional Filters Two

Flow cell system 18 µL flow cells with 10 mm light path, inter
changeable with disposable macro, semi-micro or
special optical glass cuvettes.
Carry Over Below 1% with 500 µL of Aspirated Sample.

Aspiration With Peristatic Pump
Printer Graphic, Thermal printer
Power 115 to 260 VAC, 47 to 63 Hz
Power Consumption 110 W
Temperature control 25˚C, 30˚C, 37˚C
Temperature stabilizing time From 25˚C to 37˚C in 5 minutes.
Temperature Sensibility 0.1°C
Measuring Range 0-3.5 OD
Measuring Time 3 Seconds
Drift Lower than 0.005 in OD per hour.
Photometric linearity R²>99%
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2. Installation
2.1 Unpacking and Installation
Place the shipment containing the analyser in upright position and remove the BOPP tape.
Carefully lift the analyser with the supporting cushion packing and place on clean table-top.
Do not use any sharp objects or gadgets to unpack the shipper as they can cause damage to
the analyser inside.
After unpacking the shipping package, please verify that the product does not have any
damage from shipment and make sure all listed components are included.
Power supply cable, Ethernet cable, Waste Bottle with Holding Clamp, Paper roll (2 Nos),
User manual, Warranty Card, Dust Cover, Pipette Holder, Pipette 100-1000 µL & 5-50 µL.
2.2 Installation Environment

1. Mispa Plus should be installed in a clean environment and it should be placed on a flat table
surface.
2. Maintain 200mm distance between the analyser and wall for proper ventilation. For the long
life of the analyser these temperature conditions should be maintained, and the site should
not have direct sunlight.
3. The recommended room temperature and humidity are
• Temperature: 15-45˚C (operating) and 5-50˚C (non-operating).

• Relative humidity 20-80% (operating) and 0-90% (non-operating), without condensation.
• Altitude: Less than 2000m (operating)
2.3 Printer and paper installation

1. Pull up the printer cover on the left top of the analyser.
2. Place the paper roll in the indented area.
3. Close the paper roll in the indented area.
4. Close the printer cover
(a)
(b)
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(c) (d)
Figure 2-1 Printer and paper installation
2.4 Power supply connection

Follow the steps.
1. Before connecting the power cord, check the AC power supply corresponding to the value
that is stated on the analyser label.
2. Make sure that your AC main line has an efficient ground line. Bad ground line connection
may affect analysis result and damage the analyser.
3. Connect power cord to the port, at the rear panel of the analyser.
Figure 2-2 Connecting to the power

Caution
1. Connect the power plug to a good, grounded AC wall outlet, preferably one that is not
shared with other electric appliance and with low function of line voltage compared to
the standard voltage specified (10-15%).
2. Keep the analyser away from other appliances that generate high frequency electric noise
(eg: radiological instrument).
3. Before installing the analyser or connecting the power, make sure that the analyser is
turned off.
4. Make sure that your AC main line has an efficient ground line. Bad ground line connection
may affect analysis result and damage the instrument.
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2.5 Connecting waste bottle
1. To avoid the spilling of waste water around the analyser, make sure that waste outlet
tube is connected to waste bottle properly.
Figure 2-3 Connecting Waste Bottle
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2.6 Test trial
Do not operate the touch screen with sharp objects such as pin, pen tip, nails
etc as they can cause scratches and damage on display screen
• Turn “ON” the power switch, present at the back of the analyser.
• Analyser gets switched on. The analyser will perform the start-up function and
display the main screen after successfully completing the start-up function.
• Perform wash function by selecting the wash function from main menu.
• Once the analyser is stabilized, kindly perform1-2 tests and evaluate the test results.
• Confirm that the analyser is working as per specifications.
3 Basic Operating Instructions

3.1 How to aspirate liquid
Dip aspiration tip inside the Test-tube/cuvette. Ensure that aspiration tube is completely
immersed into reagent to avoid any air to be aspirated. Press the aspiration switch, which is
present at the front of the analyser. The analyser will aspirate correct amount of liquid as per
the pre-programmed volume. Aspiration automatically stops after aspirating the programmed
volume. The recommended minimal aspiration volume is 250 µL (0.25mL). In order to reduce
the carryover and interference, the analyser is programmed to have air gap between two
aspirations.
3.2 Instructions for the correct aspiration
• Prepare the reagent and sample in a Test-tube based on the selected test.
• Dip aspiration tube inside the Test-tube. Make sure that the aspiration tube-laying bottom
end of the Test-tube, for the complete aspiration of the set volume.
• Press the aspiration switch, so that sample will aspirate automatically and make sure that
aspiration completed before removing the Test-tube.
3.3 Reset and Turn off
• To reset the analyser, turn off the main power switch at the back of analyser.
• Wait for 10 sec.
• Turn “ON” the power switch.
3.4 Automatic display sleep function
• LCD sleeping function enabled it to save the power.
• User can set the sleeping time based on their needs, using setup function.
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3.5 Common icons in all screens

Some of the icons seen in all the screens are detailed below.
Icon Description
Power cable plug
Waste bottle empty
Waste bottle full
Warning
Temperature becoming stable
Temperature unstable
Temperature stable
To start the wash process
To stop wash
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4. Analyser Settings and Functions

4.1 Start Up
Figure 4-1 Start Up screen
• Turn ‘ON’ the power switch located behind the analyser.

• Analyser will start the initialization process and ‘welcome screen’ gets displayed with
analyser name.
Figure 4-2 Temperature Stabilization screen
• Once we switch ON the power, temperature stabilization will start.

• While the analyser does the configuration and other set up, a progress bar will be shown.
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4.2 Home
Figure 4-3 Home screen

Once the setup is complete, the Mispa plus dashboard will be seen.
• Test – proceeds to test list page

• Maintenance – proceeds to maintenance settings page
• Absorbance – to check absorbance
• History – to view history
• Help – to view the Help screen
• Click ‘Start Wash’ to perform wash and when clicked will toggle to ‘Stop Wash’.
• Tip of the day – shows some tips for the user.
• Quality Check – shows the tests pending for quality check
• View History – shows the tests so far done
• Quick Test – Clicking on any of the test, leads directly to Test Run screen, as explained in
4.3.2
• Edit – By clicking ‘Edit’, the user will have the option to change the Tests displayed in the
Quick Test section in Home screen.
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4.3 Test
4.3.1 Test List
Figure 4-4 Test screen
• All 300- test names will be displayed, 20 tests per screen and we can move to the next
set of tests by moving the horizontal scroll.
• Select a particular test to run the test process
Figure 4-5 Test Screen – Begin Test
• Analyser will load and display the selected test run screen. (as shown above)
It displays the program details of the test.
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4.3.2 Begin test

• Clicking on the Begin Test button proceeds to test run. Based on the test selected, it
can be of fixed, single and multi-standard.
Test with fixed factor
Figure 4-6 Test with fixed factor
Test with single standard
Figure 4-7 Test with single standard
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Test with multi standard
Figure 4-8 Test with multi standard
• The right side Calibrate column will change based on fixed, single
or multi standard test. For fixed test, the Calibrate button will be disabled.
• There is a display panel towards the

right of the test name which displays instructions for the user. Follow the
instructions to perform the test properly.
• User can enter the Patient Name and Patient Id. User can either enter the Patient
Id or it will take an auto increment value
• Factor and blank value will be calculated.
• to perform quality check
• to print the details
• to feed paper
• to return to test list page
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4.3.3 Quality Check
Figure 4-9 Quality check Screen
• The Quality Check on the test detail screen brings to Quality Check home screen.
• In this screen, there is a dropdown to select the QC level. By default, level 1 is selected,
and the corresponding values for that particular level will be displayed along with the
graph.
• You can change the QC level from the dropdown and the corresponding values will be
shown along with graph.
• The right-side column shows the number of QCs performed for the selected QC level.
4.3.3.1 Run QC
Figure 4-10 QC Run Screen

Above screen shows QC run for test with fixed factor.
To run the QC follow the below procedure
• Run the QC, same as Test run.
• Select QC level which need to run and the graph will be plotted.
• Right hand side, we have the option to calibrate for single and multi-standard test.
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4.3.3.2 QC History
Figure 4-11 QC History Screen
• Displays the history of quality checks performed for the selected test.
• At a time, 10 entries will be shown, click on left/right arrow keys to move to next list
of entries.
• <- Back to return to QC test run page.
4.3.3.3 QC Set Up
Figure 4-12 QC Set Up Screen
• Select QC level from the left column

• Enter the Mean and SD of the selected item.
• Enter the Lot number, Expiry date and manufacturer of the Reagent used.
• Click “Save” to save the entered data
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• <-Back to return to Quality check home.

4.3.4 Program test
• Program Test screen has 6 sections which are detailed below. Move to each
section by clicking the left/right arrow keys
4.3.4.1 General
Figure 4-13 Program Test screen - General

• Enter the general details like test name, test code, select method, blank,
temperature and slope of reaction.
4.3.4.2 Result
Figure 4-14 Program Test screen – Result
• Enter the Aspiration volume, check the radio button for wavelength. Select the
dropdowns for Wavelength 1 and Wavelength 2. If wavelength ‘Double’ is checked,
select the Decimal and Unit dropdowns to set the result format.
• Print – to print the details
• Save – to save the entered data.
• <-Back to return to test detail page.
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4.3.4.3 Time
Figure 4-15 Program Test screen - Time

• Enter the Delay time, delta time, number of readings and select the Delta OD from
the options given in dropdown.
4.3.4.4 Calibration
With fixed factor
Figure 4-16 Program Test screen - Calibration

• Enter the factor for calibration of single standard test.
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With single standard or multi standard
Figure 4-17 Program Test screen - Calibration
• For single and multi-standard tests, choose the standard and select the type. Use
the dropdown for Number of Standards to choose single or multi standard. Enter
the concentration and factor range (for single standard only) and Absorbance will
be calculated.
• If number of standards is greater than 5, click on the down arrow “6-10” to display
the next series from 6 to 10.
4.3.4.5 Reference
Figure 4-18 Program Test screen - Reference
• Enter the appropriate ranges and linearity limit.
• Click on the right arrow “>” to move to next screen
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Figure 4-19 Program Test screen – Reference Parameters
• Enter the appropriate data for reference parameters.

• <- Back to return to test detail page.
4.3.4.6 Miscellaneous
Figure 4-20 Program Test screen - Miscellaneous
• Enter the appropriate details.
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4.4 Maintenance
Figure 4-21 Maintenance Screen
• System settings are set up by the user

• Service and factory settings are not accessible by users.
4.4.1 General
Figure 4-22 Maintenance Screen - General

• Enter the general details of the system.
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4.4.2 Temperature
Figure 4-23 Maintenance Screen - Temperature
• Set the temperature
4.4.3 Pump Calibration
Figure 4-24 Maintenance Screen – Pump Calibration
• Click ‘Calib’ and an instruction will be displayed asking the user to aspirate 3 mL of
water. Press the aspiration switch and aspirate 3mL of water. Once the water is
empty, release the switch. Be sure, no air gets aspirated. The observed value will
be shown. For fine tuning, click the upper or lower values.
• Once done, click the ‘Check calibration’ button and aspirate 500 mL of water to
confirm the calibration.
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4.5 Absorbance
Figure 4-25 Absorbance Screen

In order to check the optical density of a sample at specified wavelength perform the
absorbance check.
• Select filter and press the button. The button will toggle to , so
that the user can stop when required.
• Follow the instructions shown in the display panel at the right-hand side top.
• After aspiration, analyser will plot the graph along with the ABS value.
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• If the user wants to know the absorbance of any new sample with respect to the current
aspirated sample, click on so ABS will be set to 0.00 and the running sample
will be considered as blank for the next sample.
ABS Settings
Figure 4-26 Absorbance Screen – ABS Settings
• Enter the delay time, print interval, aspiration volume and temperature and click ‘Save’
option to save the ABS settings.
4.6 History
Figure 4-27 History Screen

The analyser is made with inbuilt storage capacity of 5000 test results.
The user can review and retrieve these saved data through “History “function.
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User can perform search by the following ways

• Click on ‘All Tests’ which leads to test list page.
Figure 4-28 History Screen – Test list page
• Select a particular test to display the results calculated for that test.
Figure 4-29 History Screen – Test Result

• The filtered results by test name can again be filtered by entering patient id or by entering
the data range.
• We can also perform search directly by either entering the patient id or by date range.
• Selecting a row highlights that particular result and we can print it.
• Click ‘Select All’ and ‘Print’ to print all records.
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• Analyser will load and display the Serial No, Date, Pt ID, Test Name, Result, unit and flag.
• At a time, 10 entries will be displayed. To see more, make use of left/right arrow keys to
scroll the entries.
4.7 Help
Figure 4-30 Help Screen
• You can view the system details, guidelines, operations and contact details by clicking on
the corresponding tabs.
• Use the vertical scroll to view further contents down.
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5. Maintenance
5.1 Wash
After the completion of each test/QC run, it is recommended that the flow cell should be
washed with distilled water. This is possible every time even when analyser is in RUN mode.
• Select the “Wash” button from the main menu. The pump will drain out the water at high
speed from the flow cell.
• It is necessary to repeat the operation without water so that the water remaining inside
the analyser can be expelled completely.
5.2 Daily Maintenance
• Flow cell cleaning using distilled water or any recommended cleaning solution through
wash function.
• Select “Wash” key from the main menu for the flow cell washing
• The peristaltic pump will aspirate the distilled water/cleaning solution.
• Use wet cloth to remove the spillage if any on the instrument.
5.3 Periodical Maintenance
• Every week perform at least two complete washing cycle using DI Water.
• Wipe the external surface of the analyser every month with non-abrasive detergent using
soft sponge.
• Wash the waste bottle interior with clean water or disinfectant if necessary.
• In the case of keeping the Analyser standstill for more than two weeks keep the rubber tube
of the Peristatic pump outside of pump and while using the Analyser again connect rubber
tube in position with some silica gel as lubricant.
Do not use corrosive detergent to wash analyser
Page 32 of 35
[ADL/RDE/P016/044 -R00]
6. Messages
6.1 Error Messages
Error Message Cause Solution

Filter error Filter home position error Contact Agappe service
engineer
Printer Error Paper roll may be empty Reload new printer roll
printer is not working Check the printer setup
Paper jam Open the printer head,
remove the paper jam and
press feed switch
Flow cell Temperature Error Peltier or temperature Turn off the main power and
connecter may be loose wait for 3 sec then turn on
contact back the power switch, if the
problem remains same contact
service engineer.
Flow cell Temperature Error May be loose contact at Turn off the main power and
Heater or Temperature wait for 3 sec then turn on the
connecter power switch, if the problem
remains, contact service
engineer.
6.2 Warning Messages
Warning Message Cause Solution

Aspiration Error or Tubing Aspirate again carefully as per
Bubble Detected Error the procedure., If the warning
remains same contact service
Engineer.
Waste Bottle Full Waste Bottle Full Empty the waste bottle as per
procedure.
Connection Lost Communication Error/Network Turn off the main power and
Problem wait for 3 sec then turn on
the power switch, if the
problem remains, contact
service engineer.
Page 33 of 35
[ADL/RDE/P016/044 -R00]
7. Abbreviations
• CAL / Calib - Calibration
• ABS - Absorbance
• CONC - Concentration
• SD - Standard deviation
• CV - Coefficient of variation
• AVG - Average
• Vol - Volume
• Asp - Aspiration
• Deg - Degree
• PT ID - Patient ID
• Intrvl - Interval
• H - High
• L - Low
• N - Normal
• RES - Result
• STD -Standard
• Factor calculation for End point method
= Std Con / Absorbance
• Factor in Fixed time and Kinetic method
= Standard Con / Delta Absorbance
• Mean =
• SD =
• CV% = (SD / Mean) * 100
Note: Any disposal of the equipment should be done based on the local regulation requirement.
Page 34 of 35
HAND BOOK
WRITING NOTES
35
MISPA PLUS
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
OFFICE COPY HAND BOOK
PRE-INSTALLATION CHECK REPORT

1. Customer Details
Name of Institution/Hospital/Laboratory:
Address:
Contact Name: Mobile Number:
2. Basic Site Requirements
2.1 Power Requirements
1. Power Supply Provision. AC 220V ± 10V max/hour YES NO

2. Voltage of Zero Curve to ground should be ≤3.0V YES NO
2.2 Environmental Requirements
1.The room temperature is maintained between 18 °C to 25°C

YES NO
2. Free from dust, mechanical vibrations, loud noises and electrical interference like
electrical motors and high-power rating equipment (hot air ovens)
YES NO
3. Direct sunlight or any other form of heat does not fall on the instrument YES NO
2.3 Space Requirements
1. A minimum of 20 cm space required on eitherside of the instrument, which is mandatory Not

for proper air circulation to reduce the internal heat of equipment
Available
Available
Not
2. At least 15 cm of space required behind the instrument for cabling and proper ventilation Available
Available
3. Instrument Data
Instrument Type: Instrument Model:
4. UPS Requirement, Brand, Rating, Output Power and Frequency Confirmation
UPS Make: Model: Rating:
P-N: P-E: N-E:

5. Remarks from the Engineer
Pre-installation Check
Date & Signature
Done By
Customer Name Date Signature and Seal
36
Applicable only for installation in India MISPA PLUS
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
INSTALLATION REPORT
CUSTOMER DETAILS
Name of the customer:.......................................................................................................................
Installation Address:..........................................................................................................................
..................................................................................................................PIN:................................
Tel:............................................................. Email:. .................................................................
Contact Person:........................................... Mobile:. ...............................................................
EQUIPMENT DETAILS
Model:........................................................ Delivery Date:.......................................................
Serial No.:................................................... Installation Date:. .................................................
Invoice No.:........Date:........../........../........... Warranty expiry date:.........../............/...................
Invoiced from AGAPPE / Distributor (If through distributor , please mention the name)
Distributor Name:........................................ Plac e:...................................................................
SITE DETAILS
Vibration free platform [ ] Yes [ ] No AC line input voltage.............................................
Dust free [ ] Yes [ ] No Earth Neutral Voltage.............................................
Away from Sunlight [ ] Yes [ ] No Air Conditioned [ ] Yes [ ] No
Away from TFR/AC/UPS [ ] Yes [ ] No UPS available [ ] Yes [ ] No
TO BE FILLED BY THE CUSTOMER
Received the machine in good condition [ ] Yes [ ] No
Packing of the machine [ ] Good [ ] Not Satisfac tory
Received all accessories [ ] Yes [ ] No [ ] Partially
Comments if any:..............................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
Declaration: The items as per the order have been delivered, installed, programmed and handed over in
good condition. Training has been imparted to our satisfac tion.
For AGAPPE DIAGNOSTICS LTD. For CUSTOMER
Staff Name:.................................................. Name:. .................................................................
Regions:.................HQ:................................ Sign:. ...................................................................
Sign:........................................................... Date:. ..................................................................
Date:........................................................... Seal:. ....................................................................
38
CUSTOMER COPY HAND BOOK
INSTALLATION REPORT
CUSTOMER DETAILS
Name of the customer:.......................................................................................................................
Installation Address:..........................................................................................................................
..................................................................................................................PIN:................................
Tel:............................................................. Email:. .................................................................
Contact Person:........................................... Mobile:. ...............................................................
EQUIPMENT DETAILS
Model:........................................................ Delivery Date:.......................................................
Serial No.:................................................... Installation Date:. .................................................
Invoice No.:........Date:........../........../........... Warranty expiry date:.........../............/...................
Invoiced from AGAPPE / Distributor (If through distributor , please mention the name)
Distributor Name:........................................ Plac e:...................................................................
SITE DETAILS
Vibration free platform [ ] Yes [ ] No AC line input voltage.............................................
Dust free [ ] Yes [ ] No Earth Neutral Voltage.............................................
Away from Sunlight [ ] Yes [ ] No Air Conditioned [ ] Yes [ ] No
Away from TFR/AC/UPS [ ] Yes [ ] No UPS available [ ] Yes [ ] No
TO BE FILLED BY THE CUSTOMER
Received the machine in good condition [ ] Yes [ ] No
Packing of the machine [ ] Good [ ] Not Satisfac tory
Received all accessories [ ] Yes [ ] No [ ] Partially
Comments if any:..............................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
........................................................................................................................................................
Declaration: The items as per the order have been delivered, installed, programmed and handed over in
good condition. Training has been imparted to our satisfac tion.
For AGAPPE DIAGNOSTICS LTD. For CUSTOMER
Staff Name:.................................................. Name:. .................................................................
Regions:.................HQ:................................ Sign:. ...................................................................
Sign:........................................................... Date:. ..................................................................
Date:........................................................... Seal:. ....................................................................
40
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
“Agappe Hills”, Pattimattom (PO), Dist. Ernakulam, Kerala - 683 562, India.
TEL: + 91 484 2867000 | customersupport@agappe.in | www.agappe.com
ONE YEAR WARRANTY CERTIFICATE
Model:.....................................................................Serial Number:.......................................................
Purchased from:................................................................................................................................
Date of installation:................................................................................................................................
Customer name:.............................................................................................................
Address:............................................................................................................Pin:....................
Phone:..........................................Fax:.............................E-mail:.........................................................
1. WARRANTY CONDITIONS:
1.1. To activate the warranty, the customer must fill all the columns and
return the slip to AGAPPE.
1.2. AGAPPE, guarantees that all its instruments are free from
manufacturing defects or faults, as are the materials used. AGAPPE
undertakes to repair and substitute free of charge any part which may be 4. TERMINATION OF WARRANTY
found to have manufacturing defects. 4.1. This warranty shall be terminated at the end of the guarantee period
2.VALIDITY AND DURATION and also in the following cases:
2.1 The warranty will be valid and provided only if the original invoice or a. Where attempts to make repairs or alteration have been made by
sales receipt and the warranty card which must be properly completed and unauthorised person and/or with spare parts which are not originals.
indicating the date of purchase, model name, dealer's name, and serial b. Alteration have been made to the serial number of the product or of the
number of the product that are presented with the defective product within certificate.
the warranty period. c. The instrument is transferred to a new location without prior written
2.2. Agappe will refuse the Warranty if these documents are not presented or approval from ADL.
if they are incomplete. Moreover this warranty will not apply if the model 5. ELEMENTS NOT COVERED BY THE WARRANTY
name and the serial number on the product have been deleted or altered and 5.1. The following damage and faults are not covered by warranty.
if the date of the installation, model name, serial number and the dealers a. Damage deriving and/or originating from an insufficient or inadequate
name on the warranty card have been altered or deleted. electric circuit or from the power input in the area where the instrument
2.3. The warranty is valid for a period of 12 months from the date of is set up and used.
installation or 13 months from the date of purchase(billing), whichever is b. Breakdowns caused by careless handling, imprudence, lack of expertise
earlier. and in any case caused by lack of skill or any degree of negligence on the
3.WARRANTY AND CONDITIONS part of the operator.
3.1. Such parts of the instruments as may have defects due to materials or c. Damage defects and faults deriving from unexpected events, accidents
manufacture will be repaired and/or substituted free of charge. during transport by purchaser, due to FORCE MAJORE and in any case,
3.2. The warranty does not cover defects of parts which are subject to normal due to situation which can in no way be attributed to manufacturing
wear and tear and which are normally changed from time to time during and/or material defects.
maintenance procedures for the instrument. 5.2. Substitution of the defective instrument is never foreseen.
In any case, parts which are normally changed during maintenance 5.3. AGAPPE shall accept no responsibility whatsoever for damage either
procedures will also be substituted or repaired if they have manufacturing directly or indirectly to persons or materials from the use of the
and/or material defects such as to make it impossible to use the instrument instrument.
or such as to alter the proper functions of the instrument. 5.4. Consumable item such as fuses, lamps all tubings etc are not covered
3.3. Repairs and interventions carried out during the period of warranty do under this warranty condition.
not extend or renew said period of warranty. The repairs of the instrument 6. GOVERNING LAW
will be carried out by authorised technicians, on request by the customer to 6.1. The court of law of Ernakulam shall have exclusive jurisdictions for
the company. any controversies that may arise regarding this warranty certificate.
CUSTOMER NAME: STAMP AND SIGNATURE STAMP AND SIGNATURE

AGAPPE DIAGNOSTICS LTD.
42
“Agappe Hills”, Pattimattom (PO), Dist. Ernakulam, Kerala - 683 562, India.
TEL: + 91 484 2867000 | customersupport@agappe.in | www.agappe.com
ONE YEAR WARRANTY CERTIFICATE
Model:.....................................................................Serial Number:.......................................................
Purchased from:................................................................................................................................
Date of installation:................................................................................................................................
Customer name:.............................................................................................................
Address:............................................................................................................Pin:....................
Phone:..........................................Fax:.............................E-mail:.........................................................
1. WARRANTY CONDITIONS:
1.1. To activate the warranty, the customer must fill all the columns and
return the slip to AGAPPE.
1.2. AGAPPE, guarantees that all its instruments are free from
manufacturing defects or faults, as are the materials used. AGAPPE
undertakes to repair and substitute free of charge any part which may be 4. TERMINATION OF WARRANTY
found to have manufacturing defects. 4.1. This warranty shall be terminated at the end of the guarantee period
2.VALIDITY AND DURATION and also in the following cases:
2.1 The warranty will be valid and provided only if the original invoice or a. Where attempts to make repairs or alteration have been made by
sales receipt and the warranty card which must be properly completed and unauthorised person and/or with spare parts which are not originals.
indicating the date of purchase, model name, dealer's name, and serial b. Alteration have been made to the serial number of the product or of the
number of the product that are presented with the defective product within certificate.
the warranty period. c. The instrument is transferred to a new location without prior written
2.2. Agappe will refuse the Warranty if these documents are not presented or approval from ADL.
if they are incomplete. Moreover this warranty will not apply if the model 5. ELEMENTS NOT COVERED BY THE WARRANTY
name and the serial number on the product have been deleted or altered and 5.1. The following damage and faults are not covered by warranty.
if the date of the installation, model name, serial number and the dealers a. Damage deriving and/or originating from an insufficient or inadequate
name on the warranty card have been altered or deleted. electric circuit or from the power input in the area where the instrument
2.3. The warranty is valid for a period of 12 months from the date of is set up and used.
installation or 13 months from the date of purchase(billing), whichever is b. Breakdowns caused by careless handling, imprudence, lack of expertise
earlier. and in any case caused by lack of skill or any degree of negligence on the
3.WARRANTY AND CONDITIONS part of the operator.
3.1. Such parts of the instruments as may have defects due to materials or c. Damage defects and faults deriving from unexpected events, accidents
manufacture will be repaired and/or substituted free of charge. during transport by purchaser, due to FORCE MAJORE and in any case,
3.2. The warranty does not cover defects of parts which are subject to normal due to situation which can in no way be attributed to manufacturing
wear and tear and which are normally changed from time to time during and/or material defects.
maintenance procedures for the instrument. 5.2. Substitution of the defective instrument is never foreseen.
In any case, parts which are normally changed during maintenance 5.3. AGAPPE shall accept no responsibility whatsoever for damage either
procedures will also be substituted or repaired if they have manufacturing directly or indirectly to persons or materials from the use of the
and/or material defects such as to make it impossible to use the instrument instrument.
or such as to alter the proper functions of the instrument. 5.4. Consumable item such as fuses, lamps all tubings etc are not covered
3.3. Repairs and interventions carried out during the period of warranty do under this warranty condition.
not extend or renew said period of warranty. The repairs of the instrument 6. GOVERNING LAW
will be carried out by authorised technicians, on request by the customer to 6.1. The court of law of Ernakulam shall have exclusive jurisdictions for
the company. any controversies that may arise regarding this warranty certificate.
CUSTOMER NAME: STAMP AND SIGNATURE STAMP AND SIGNATURE

AGAPPE DIAGNOSTICS LTD.
44
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
46
MISPA PLUS
OFFICE COPY
Any overall observations / comments
Applicable only for installation in India

The above maintenance is designed in an assumption that the water quality used is of type II as per international standards.
HAND BOOK
MISPA PLUS
MISPA PLUS
48
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
50
OFFICE COPY
MISPA PLUS

HAND BOOK
MISPA PLUS
MISPA PLUS
52
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
54
MISPA PLUS
OFFICE COPY

HAND BOOK
MISPA PLUS
MISPA PLUS
56
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
58
OFFICE COPY
MISPA PLUS

HAND BOOK
MISPA PLUS
MISPA PLUS
60
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CUSTOMER DATA COLLECTION AFTER INSTALLATION
Name & Address of the Customer
Contact Person Name,

Designation&Number
E-Mail ID
Equipment Installed Mispa PLUS
Other Equipment's in Lab
Approximate Work Load Sl. No Particulars

1 Biochemistry
2 Haematology
3 Others
Future Prospects Sl. No Particulars

1 Reagent
2 Equipment
Customer Name Region:
Signature: HQ :
Date:
62
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CHECK POINTS AFTER INSTALLATION
From Machine Screen (S ystem View )
Hardware Version
M echanical version
Peripheral Software
Version
LCD Software Version
S/ No
After Gain Calibration, From Filter Status,
Filter ADC Value Gain
340 nm
405 nm
505 nm
546 nm
578 nm
630 nm
From Tem perature Service Screen,
Actual Offset
37 0 C
30 0 C
25 0 C
From Pum p Calibration Screen
No of Steps
Control Value for any two available paramet ers
QC M AKE
LOT EXP
ITEM RANGE RESULT
Customer Name: Date:

Signature:
64
CHECK POINTS AFTER INSTALLATION
From Machine Screen (System View )
Hardware Version
M echanical version
Peripheral Software
Version
LCD Software Version
S/ No
After Gain Calibration, From Filter Status,
Filter ADC Value Gain
340 nm
405 nm
505 nm
546 nm
578 nm
630 nm
From Tem perature Service Screen,
Actual Offset
37 0 C
30 0 C
25 0 C
From Pum p Calibration Screen
No of Steps
Control Value
for any tw o available param eters
QC M AKE
LOT EXP
ITEM RANGE RESULT
Customer Name: Date:

Signature:
66
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
TRAINING REPORT
Customer name & Address:
Person in Charge:
Operator:
Trainer Name:
Model Name Serial No.
Equipment details
Training Hours Trainer Sign/-
From: To:
Contents Explained Practised Remarks Advise

Function and Principle
Analysis function meaning and setting
Item parameter meaning and setting (Calibration)
Application training
Routine sample working
STAT sample working
Rerun sample working
QC setting and Graph
Date Query and printing
Parameter, Data Backup and Recovery (if any)
Daily work flow and Maintenance
LIS Online application (If any)
Customer Name:
Signature:
Date:
68
TRAINING REPORT
Customer name & Address:
Person in Charge:
Operator:
Trainer Name:
Model Name Serial No.
Equipment details
Training Hours Trainer Sign/-
From: To:
Contents Explained Practised Remarks Advise

Function and Principle
Analysis function meaning and setting
Item parameter meaning and setting (Calibration)
Application training
Routine sample working
STAT sample working
Rerun sample working
QC setting and Graph
Date Query and printing
Parameter, Data Backup and Recovery (if any)
Daily work flow and Maintenance
LIS Online application (If any)
Customer Name:
Signature:
Date:
70
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FEEDBACK FORM
Customer Name: ................................................................................................................................
Customer place: ..................................................................................................................................
Equipment Model: ...........................................................................................................................
S/ No: ................................................................................................................................................
Engineer name: ...................................................................................................................................
1. With your experience of the most recent AGAPPE Installation
Very Satisfied Satisfied Neutral Dissatisfied Very Dissatisfied Not Sure

2. With the Timelines of AGAPPE Installation

3. With the Quality of our Installations
4. AGAPPE Installation Personnel is knowledgeable and Professional
5. AGAPPE Installation service overall
6. Overall, how satisfied are you with the amount of communication between you and Agappe?
7. Would you recommend Agappe's services to colleagues or contacts within your industry?
YES NO NOT SURE
Any Other Advice
Name & Signature of person in charge: Date:
72
HAND BOOK
WRITING NOTES
74
MISPA PLUS
76
MISPA PLUS
ADL/MCD/REC/009/2020/R00 Company reserves the right to change any design and technical features of the product at any time, If needed.
For India and Nepal

Toll Free Number 1: 1800 425 7151
ISO 9001:2015 Toll Free Number 2: 1800 270 7151
EN ISO 13485:2016 Toll Free Number 3: 1800 891 7251
Email: customersupport@agappe.in
Corp Address : “Agappe Hills”, Pattimattom (PO), Dist. Ernakulam, Kerala - 683 562, India.
www.agappe.com

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Advanced Semi Automated Clinical Chemistry Analyser

Greetings from AGAPPE DIAGNOSTICS LIMITED!

We acknowledge your patronage to AGAPPE’s quality

With more than two decades of our service to

Our toll free Customer Support number can be

Our MISPA CARE team with ﬂeet of Service

We have more than 24000 satisﬁed customers, who

We thank you for giving us an opportunity to serve

Agappe Diagnostics Ltd., Cochin.

EXPERTISE THROUGH EXPERIENCE & INNOVATION

External power supply Waste Bottle with Float sensor (1No.)

Prepared by: Prepared by:

• The Analyser must be free of obstruction.

3. Caution for Biohazard Management

5. Customer service department

Manufacturer Agappe Diagnostics Ltd

4.7 Help .................................................................................................... 31

Figure 1-1 Front View of Mispa Plus ........................................................................... 7

Figure 1-1 Front View of Mispa Plus

Figure 1-2 Rear view of Mispa Plus

• Integrated pump and flow cell.

• Ethernet and USB connectivity.

Provision for optional Filters Two

Carry Over Below 1% with 500 µL of Aspirated Sample.

2.2 Installation Environment

• Temperature: 15-45˚C (operating) and 5-50˚C (non-operating).

2.3 Printer and paper installation

Figure 2-1 Printer and paper installation

2.4 Power supply connection

Figure 2-2 Connecting to the power

2.5 Connecting waste bottle

Figure 2-3 Connecting Waste Bottle

2.6 Test trial

3 Basic Operating Instructions

3.5 Common icons in all screens

Power cable plug

Waste bottle empty

Waste bottle full

Temperature becoming stable

To start the wash process

4. Analyser Settings and Functions

Figure 4-1 Start Up screen

• Turn ‘ON’ the power switch located behind the analyser.

Figure 4-2 Temperature Stabilization screen

• Once we switch ON the power, temperature stabilization will start.

Figure 4-3 Home screen

• Test – proceeds to test list page

Figure 4-4 Test screen

• Select a particular test to run the test process

Figure 4-5 Test Screen – Begin Test

4.3.2 Begin test

Test with fixed factor

Figure 4-6 Test with fixed factor

Test with single standard

Figure 4-7 Test with single standard

Test with multi standard

Figure 4-8 Test with multi standard

• There is a display panel towards the

• to perform quality check

• to print the details

• to return to test list page

4.3.3 Quality Check

Figure 4-9 Quality check Screen

Figure 4-10 QC Run Screen