ELISA PLATE READER

Add to my manuals
117 Pages

advertisement

ELISA PLATE READER | Manualzz

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

ELISA PLATE READER

DIA2000

Version – 3.400A

DIAsource ImmunoAssays S.A.

Rue du Bosquet 2 B-1348 Louvain-La-Neuve

BELGIUM

Phone : +32 10 84 99 11

Fax : +32 10 84 99 90 www.diasource.

be

[email protected].

Version 150511 PI number: 1701327 Page 1 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

TABLE OF CONTENTS

1. GENERAL INFORMATION

...................................................................................................... 5

1.1. Warranty Information

..................................................................................................................... 5

1.2. Technical Service

.............................................................................................................................. 5

1.3. Contacts

............................................................................................................................................ 5

2. GENERAL SAFETY WARNINGS

.............................................................................................. 6

2.1. Danger – warning symbols

............................................................................................................... 6

2.2. Use of the Instrument

....................................................................................................................... 7

3. INTRODUCTION

........................................................................................................................ 8

3.1.

Description ....................................................................................................................................... 8

3.2.

Special Features ............................................................................................................................... 8

3.3. Technical Specification

..................................................................................................................... 9

4. PACKAGING, TRANSPORT AND STORAGE

........................................................................ 11

4.1.

General Warnings .......................................................................................................................... 11

4.2.

Packaging ....................................................................................................................................... 11

4.3. Instrument Transportation

............................................................................................................ 11

4.4.

Storage of Instrument .................................................................................................................... 11

5. INSTRUMENT DESCRIPTION

............................................................................................... 12

5.1.

Instrument Working Principle ...................................................................................................... 12

5.2.

Perspective View ............................................................................................................................. 14

5.3. Keypad

............................................................................................................................................ 15

6. INSTALLATION PROCEDURE AND VERIFICATION CRITERIA

...................................... 17

6.1. Unpacking Instructions

.................................................................................................................. 17

6.2. Placing the Instrument

................................................................................................................... 17

6.3. Power Supply Requirements

.......................................................................................................... 17

Version 150511 PI number: 1701327 Page 2 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

6.4. Protective Grounding

..................................................................................................................... 17

6.5. Printer

............................................................................................................................................. 17

6.6. Start up Instructions

....................................................................................................................... 19

6.8.

Micro Titer Plate Carriage ............................................................................................................ 21

6.9.

Plate Loading & Pipetting Procedure ........................................................................................... 21

6.10. Readings Check

............................................................................................................................ 22

7. PRECAUTIONS

........................................................................................................................ 22

8. PROGRAMMING MODES

....................................................................................................... 23

8.1. Absorbance Mode

........................................................................................................................... 23

8.2. Single Standard

.............................................................................................................................. 26

8.3.

Cut Off Mode ................................................................................................................................. 27

8.4. Reverse Cut Off Mode

.................................................................................................................... 43

8.5. Multi Standard Mode:

.................................................................................................................... 44

8.6. Percentage Absorbance

.................................................................................................................. 55

8.7. Uptake

............................................................................................................................................. 55

8.8.

Kinetic ............................................................................................................................................. 56

9. RECALLING AND RUNNING OF STORED TEST/PROGRAMS

.......................................... 57

9.1. Absorbance Mode:

.......................................................................................................................... 58

9.2. Cut off Mode

................................................................................................................................... 62

9.3. Multistandard

................................................................................................................................. 69

10. RERUNNING ACCEPTED TESTS / PROGRAMS

................................................................ 81

11.SAMPLE AND SAMPLE DUPLICATE

.................................................................................. 85

12.PATIENT IDENTITY / SAMPLE IDENTITY ENTRY

........................................................... 87

13.SAVE PLATE AND SAVE RESULTS

..................................................................................... 90

14.VIEW STORED DATA

............................................................................................................. 92

15. UTILITIES

.............................................................................................................................. 94

Version 150511 PI number: 1701327 Page 3 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

15.1. Date & Time Setting

..................................................................................................................... 95

15.2. Program Filter

.............................................................................................................................. 95

15.3. Printer On / Off setting:

............................................................................................................... 96

15.4. Enter Clinic Name:

....................................................................................................................... 96

15.5. Shaker (Plate Shaking Mode)

....................................................................................................... 97

15.6. Communication Settings:

............................................................................................................. 98

15.8. Install USB Driver:

....................................................................................................................... 99

15.9. Auto Print: ON

............................................................................................................................. 99

15.10. PASSWORD:

............................................................................................................................ 100

16. SERIAL COMMUNICATION

............................................................................................... 103

17.1. Clear Memory

............................................................................................................................. 109

17.2. Lamp Amplitude

......................................................................................................................... 110

17.3. Printer Self test

........................................................................................................................... 112

19. DECONTAMINATION

......................................................................................................... 115

19.1. Decontamination Procedure ........................................................................................................115

19.2 Purpose of Decontamination ........................................................................................................115

19.3. General Considerations ...............................................................................................................115

19.4. Procedure .....................................................................................................................................115

20.

SAFETY CLEARANCE CERTIFICATE .............................................................................. 116

Version 150511 PI number: 1701327 Page 4 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

1. GENERAL INFORMATION

1.1. Warranty Information

Each Instrument is completely tested and guaranteed for twelve months from delivery

The warranty applies to all the mechanical and electrical parts. It is valid only for proper installation, use and maintenance in compliance with the instructions given in this manual.

DIASOURCE IMMUNOASSAYS S.A.

will, at its discretion repair or replace parts, which may be found defective in the warranty period. The warranty does not include any responsibility for direct or indirect personal and material damages, caused by improper use or maintenance of the instrument.

Parts that are inherently subject to deterioration are excluded from the warranty. In case of defects due to misuse of the instrument, any travel and man-hour expenses will be charged extra.

1.2. Technical Service

DIASOURCE IMMUNOASSAYS S.A.

is always accessible to the customers for any kind of information about installation, use, maintenance and others. When asking for service, please refer to this manual and report the data reported on the identification label (serial number).

Only qualified technicians are entitled to repair instruments. The user should carry out ordinary maintenance.

1.3. Contacts

DIASOURCE IMMUNOASSAYS S.A.

Rue du Bosquet 2

BE-1348 Louvain-La-Neuve

BELGIUM

IVD Instrumentation Support Service

Hotline phones availabilities : Monday to Friday; 08 :30 to 17:00 (Belgium time)

Please contact first Hotline 1. In case of no response please contact Hotline 2.

Hotline 1 phone number : 0032 (0)10 849932

Hotline 2 phone number : 0032 (0)10 849976

Fax : 0032 (0)10 849990

Email :

[email protected]

Version 150511 PI number: 1701327 Page 5 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

2. GENERAL SAFETY WARNINGS

2.1. Danger – warning symbols

This is a symbol of generic danger. It means that, serious damage can occur to the operator if described precautions are not observed.

This is a symbol of HIGH ELECTRIC VOLTAGE. It is dangerous to touch any part having this label. Only qualified operators can access these components, after unplugging the instrument from the supply.

This symbol indicates that the instrument makes use of chemical reagents and other dangerous (Corrosive, irritant, or harmful) CHEMICAL SUBSTANCES, which can cause damage to people or materials. When this label is found, pay

attention to the manufacturer’s recommendations.

This symbol indicates that the instrument involves the handling of samples, which

can be infected (urine or human serum). In this condition, infection or contamination might occur. Pay attention to the general safety warnings when in presence of such biological substances. Use protective clothes, gloves and glasses.

This symbol in the user manual indicates that damages to the instrument or erroneous results could occur if the given warnings are not respected.

This symbol indicates a portion, which is particularly important, and should be studied carefully.

This symbol indicates a Protective Earth or Ground terminal.

Version 150511 PI number: 1701327 Page 6 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

2.2. Use of the Instrument

1. The instrument has to be used for the designed purposes under specified conditions,

following proper procedures and safety rules by qualified personnel.

2. This manual contains instructions for operation performed by qualified personnel.

3. A qualified user has to make sure that environmental condition is suitable, the installation

is correct, the use and maintenance are proper according to the general safety rules as well

as to the particular precautions described in the manual. (However, he is not entitled to

repair the instrument).

4. A qualified technician is entitled to maintain and repair the instrument using the original

spare parts according to the given instructions.

5. Maintain room temperature and humidity as specified in the manual.

6. If the instrument is not used as described in the manual, the protection provided by the

instrument may be impaired.

7. Alterations to the instrument are prohibited. The user is liable for any improper

Modification to the instrument, and for the deriving consequences.

8. Contact the MANUFACTURER service or authorized service center in case the instrument

need extraordinary maintenance. Specialized technicians who will be able to repair the

instrument using original spare parts will carry out the maintenance.

9. This IVD equipment complies with the emission and immunity requirements as per

IEC61326 series.

10. Warning : This equipment has been designed and tested to CISPER11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference."

11. An advisory that the electromagnetic environment should be evaluated prior to operation of

the device.

12. Warning : Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded international RF sources), as these may interfere with the proper operation.

Version 150511 PI number: 1701327 Page 7 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

3. INTRODUCTION

3.1. Description

The ELISA PLATE READER is a user friendly micro plate Analyser. It is compact &

lightweight. It is designed to measure and interpret enzyme immunoassay results, both

monochromatically and bichromatically. It is intended for in vitro diagnostic use.

3.2. Special Features

The ELISA READER can accommodate a flat bottom as well as a round configuration.

The carriage is designed in a way that the plate automatically moves smoothly and

positions iself accurately in the optical measurement path. Readings are taken

continuously. The average value is calculated and results are presented according to the

option selected.

The ELISA READER operates on a WIDE voltage (90-270 volt). This eliminates the need for an external voltage stabilizer.

The ELISA READER has a special provision, which allows it to be used even when a

printer is not available. Readings can be conveniently noted down manually.

The other special features of ELISA READER are as follows:

 Option of Lamp saving mode.

 Selection of both primary and secondary filters.

 Latest technology with battery back-up for 250 tests with QC, more than 2500 result.

 Robust built in 52-column thermal printer with 384 stationary heads.

 Unique circuitry for long lamp life.

 Alphanumeric Patients ID entry.

 Editing of saved tests.

 Human machine user interface: Touch panel, Keypad

 Multi-standard curve up to 12 standard calibrations with one blank optional.

 Access to test by touch of key.

 Capability to connect to 80-column printer for direct report printout.

 Blank is optional.

 Setting of the Date and Time.

 Capable of storing, deleting and recalling tests.

 Multiple calibrator modes.

 Selection of duplicates for both calibrators and samples.

 Extensive software for cut off mode.

 Selection of Positive, Equivocal, Negative cut-off.

Version 150511 PI number: 1701327 Page 8 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

 Several pre-programmed calculation modes will help to facilitate data processing of enzyme immunoassays. These are menu driven modes for simple and error free operations.

Human Machine Interface

 ABSORBANCE MODE

 CUT-OFF MODE

 MULTISTANDARD MODE

 SINGLE CALIBRATOR MODE

 % ABSORBANCE MODE

 UPTAKE

 KINETIC

3.3. Technical Specification

TOUCH PANEL / KEYPAD

0.000 to 3.000 Absorbance Units (A) Linear measurement range

Photometric Accuracy

± 2% or 0.007 whichever is higher, from 0 to 1.5 A

± 3% from 1.5 A to 3.0 A

Drift

<0.005 A/hr

Photometric Linearity

2.5 A

Optical measurement

8 Channel

Filters

Type of filter

Wave Length

Half Bandwidth

Selection

Narrow band Interference

405nm, 450nm, 492nm, 630nm, 560nm

10nm ± 2nm

Automatic by Stepper Motor

Light Source

Display

Curve Plotting

Tungsten halogen lamp, 20 Watts

6” Graphics LCD, Negative Blue, STN

Graphical Representation on Printer

Version 150511 PI number: 1701327 Page 9 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

Plate Carrier Movement

Printer

Memory

Analysis Mode

Connectivity / RS232 Serial Port / USB

Power

Wattage

Voltage

Operation Position

Operating Conditions

Temperature

Relative Humidity

Storage Conditions

Temperature

Relative Humidity

Enclosure

Size (cm)

Weight (Approx.)

Precisely through the stepper motor

Built in Thermal Printer 52 columns

Battery backup supporting 2500 open channels

64 KB Non Volatile RAM

Absorbance

Single Standard

Cut-off

Multi-Standard

% Absorbance

Uptake

Kinetic

9600 baud, 8 data, 1 stop, no parity bits / USB

75 Watts

115-230 Volt ± 10%, 50/60 hz.

On horizontal flat, rigid and vibration free surface

From + 18°C to 35°C

Up to 80%

From -10°C to 40°C

Up to 80%

ABS Fire Retardant

36 x 36 x 22 (lxbxh)

10 Kgs

Version 150511 PI number: 1701327 Page 10 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

4. PACKAGING, TRANSPORT AND STORAGE

4.1. General Warnings

Instrument has to be decontaminated before packing for transportation.

4.2. Packaging

Packaging is needed whenever the instrument is to be transported or shipped by courier or other purposes.

To pack the instrument the following instructions has to be followed:

1. Decontaminate the instrument as explained on decontamination chapter of this manual.

2. Put the instrument into the original packaging box; Instrument has to be properly

protected by plastic protective material. Put copy of Safety clearance certificate (copy of

Safety clearance certificate is attached at the end of this manual)

3. Mark the packaging with address, instrument identification and warning labels

4.3. Instrument Transportation

The transportation of the instrument in unpacked condition must be limited within the room where it is used, to avoid damage.

4.4. Storage of Instrument

Before storing the instrument for a long period, pack it carefully as described above and store indoors.

Relative humidity can be up to 80%, and temperature between -10ºC and 40ºC.

Version 150511 PI number: 1701327 Page 11 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

5. INSTRUMENT DESCRIPTION

5.1. Instrument Working Principle

1. Switch on and program the instrument.

2. Place the plate firmly onto the carriage.

3. Start the test, the plate will be conveyed inside and strip is placed precisely below the

optical path. The measurement is carried out step by step.

 At the end of the cycle the results are printed at the same time they are available at the RS232 serial port output.

On starting the test, the plate will be conveyed into the instrument.

Plate is moved in step by step by a well-controlled mechanism and each well is positioned precisely below the optical path. Optical density of each well is measured as explained below.

Based on selected programming mode, sophisticated algorithms are used for analyzing the measured value and presenting the same on the printer, display & RS232 serial port for computer

Interface.

The following diagram represents the main functional elements of the instrument:

White light produced by the lamps is focused into a beam by the lens and passes through the sample. Part of the light is absorbed by the sample and the remaining light is transmitted. It is filtered by interference filters and focused onto the photodiodes. The photodiode converts the received light into an electrical signal which is transformed into a digital form, from which the microprocessor calculates the absorbance, taking in account of the blank and bichromatic selection.

Version 150511 PI number: 1701327 Page 12 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

Lamp

Lens

Memory

Wells

Lens

Filter

Lens

Analogue to Digital

Converter

Photo sensor

Amplifier

Micro Processor

Key Pad

Touch Panel

Printer

RS232

Display

Version 150511 PI number: 1701327 Page 13 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

5.2. Perspective View

Front View:

Printer

Touch Screen

Rear View:

Contrast knob

Cooling Fan

USB output

1

2

3

7

4

5

Serial RS232 O/P

Ext. Printer connection

1) Contrast Knob-use to adjust display contrast

2) Serial RS232 output 3) Cooling Fan 4) USB output

SMPS

6

Keypad

Plate Carrier/ Holder

On / Off switch

Version 150511 PI number: 1701327 Page 14 of 117

U s s e r M a n u a l l

5.3. Keypad

E L I I S A P L A T E R E A D E R

1) ‘YES’ key is used to select any ‘YES’ option on screen directly.

2) ‘NO’ key is used to select any ‘NO’ option on screen directly.

3) ‘PRINT’ key is used to get a printout of current screen displayed.

4) ‘TEST’ key is used for directly accessing the RUN screen of the selected test.

5) Navigation keys are used to select any option available on current screen.

6) ‘ENTER’ key is used to run any option selected by navigation keys.

7) ‘ESC’ key is used for escaping from any screen.

8) ‘SHAKE’ key is used for directly accessing the shaking mode (ie. SHAKER)

(refer 15.5 for more details on SHAKER)

(Note: Functions based on HOME & FEED keys operates only when it is in List Test screen or the first screen after initializing)

ELISA READER 18/07/12

Clinic name / Serial Number

Select Test

MENU

1. HBSAg 6. PER_ABS RUN / SEL

2. HCVAb 7. CRP PRNT

3. UPT 8. KIN_405 NEXT

4. TSH 9. SIN_630 PREV

5. CPC 10. CP_560 DEL

PLATE

DATA

Version 150511 PI number: 1701327 Page 15 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

User can select “List Test” screen as shown below-

1 Test Operations

MAIN MENU

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

ESC

TEST OPERATIONS

1 Select Test By Name ESC

2 Select Test By Mode

3 Select Test By Number

4 List Tests

5 Add New Test

Select Test ESC

1 HBSAg S

2 HCVAb M RUN / SEL

3. UPT U

4. TSH M PRNT

5. CPC C

6. PER_ABS P NEXT

7. CRP C

8. KIN_405 K PREV

9. SIN_630 S

10 CP_560 C DEL

PLATE

DATA

Select “TEST” button present on the keypad. It will display following screen for selecting the particular test. In this way user can directly run the selected test by just entering the valid test no.

Select Test ESC

1 HBSAg S

2 HCVAb M RUN / SEL

3. UPT U

4. TSH M PRNT

5. CPC C

6. PER_ABS P NEXT

7. ABS A

8. KIN_405 K PREV

9. SIN_630 S

10 CP_560 C DEL

Numeric Value: 7

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Name: ABS NORM – ABSORBANCE

Pri : 450 Sec : 560 BL N

ABS ABS ABS ABS ABS ABS

1 2 3 4 5 6

ABS ABS ABS ABS ABS ABS

7 8 9 10 11 12

Is Plate Loaded ? YES / NO

Version 150511 PI number: 1701327 Page 16 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

6. INSTALLATION PROCEDURE AND VERIFICATION

CRITERIA

6.1. Unpacking Instructions

Check accessories as per packing list.

Kindly store all packaging materials so as to use it to repack and ship for maintenance

or servicing.

6.2. Placing the Instrument

The instrument has to be placed on a level bench.

Room temperature has to be between 10 to 35ºC with a relative humidity below 85%.

Protect the instrument from direct sunshine.

6.3. Power Supply Requirements

Plug the instrument into a power source by the locally available approved plug in cable.

Power cord should be CE, CSA, and UL marked.

115 - 230 Volt ± 10%, 50-60 Hz

6.4. Protective Grounding

Please make sure that electrical power source is properly grounded.

6.5. Printer

ELISA READER Analyser is equipped with a built in 52 columns easy load thermal

printer. Procedure to load the paper is as follows:

Opening the Paper Cover:

Slide the LEVER towards back of the printer to open lock of the Paper Cover.

Lightly push up on the front of the paper cover (marked) with your thumb and rotate it towards the back of the printer.

Version 150511 PI number: 1701327 Page 17 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

Closing the Paper Cover + replacement of paper roller:

Close the paper cover and push down till you get locking sound.

Open the paper cover.

Remove the paper roller from the slot and place the paper roll over it as shown.

Place back the paper roller with paper into the slot provided and close the paper cover as described before.

Keep pressing the paper feed switch until the paper feeds straight and smoothly.

HINT:

When the paper is set correctly and when the closing of the paper cover is proper the FEED LED will not glow.

It keeps on flashing when the data is being printed.

When the paper is almost finished, red lines appear on both sides of the paper.

Version 150511 PI number: 1701327 Page 18 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

6.6. Start up Instructions

Switch on the instrument.

The instrument initializes all the parameters internally and carries out a power on self-test

During Initializing it displays the string: “Please wait system initializing.”

It will display the ADDRESS screen after completing the initialization.

ELISA READER

DIASOURCE IMMUNOASSAYS S.A.

Rue du Bosquet 2 - B-1348 LOUVAIN-LA-NEUVE

Tel : 00 32 10 84 99 11

Fx : 00 32 10 84 99 90

The instrument will print the model name “ELISA READER”, VERSION NUMBER, CLINIC

NAME, CURRENT DATE WITH TIME.

ELISA READER Date

Clinic name / VERSION Number MENU

Select Test

1. HBSAg 6. PER_ABS RUN / SEL

2. HCVAb 7. CRP PRNT

3. UPT 8. KIN_405 NEXT

4. TSH 9. SIN_630 PREV

5. CPC 10. CP_560 DEL

PLATE

DATA

User can select a saved test by first touching the required “Test Name” on the screen and then touch the “SEL” option to carry out further operation on the test.

“RUN” option is used to directly run the selected test.

“DEL”: Deletes the selected test.

If the numbers of tests are more than 10, “NEXT” and “PREV” options can be used for browsing through the list pages.

“PRINT”: For printing the test screen.

“MENU” used to select Main menu screen.

"PLATE DATA” this option helps the user to view the Plate Results easily by selecting this option present on the screen.

Version 150511 PI number: 1701327 Page 19 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

6.7. Touch Panel Check

ELISA READER provides a Touch sensitive LCD panel and a KEYPAD for easy use interface.

The Menus are displayed and the text of the parameter forms the TOUCH ZONE.

Touch screen Layout

Name:

Pri: 405 Sec: 0

No Factor QC

BL 0 N

NC 0 1.000 N

PC 0 1.000 N

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

EDIT

QCVal Mes. Rem RUN

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

Above is the generic representation of a Test Screen. The Highlighted zones are TOUCH

ZONES, which are active. On touching the “Touch Zone” of a parameter, a sub menu/menu is displayed or the requested action is carried out. The rest of the “Touch Zone” is deactivated.

For Example: To activate the selection:

Enter the primary filter value to touch any point in the shaded area “Pri” on the LCD screen.

On proper selection the analyser responds with blinking of the parameter text and also the

TOUCH ZONE and a submenu is displayed.

To enter Test Name: Touching the “Name” touch zone provides an alphanumeric screen.

Enter the Test name by touching the Touch zone of that variable. The selected value blinks and is displayed next to the parameter.

Selection Indicator

Selected on screen item is shown in a shaded background. When the screen first displays, the default selection is shown. Pressing a selection either highlights that item or activates it.

Version 150511 PI number: 1701327 Page 20 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

6.8. Micro Titer Plate Carriage

The instrument is provided with a micro titer plate carriage to move the micro titer plate inside.

This carriage is driven by stepper motor with timing belt. It places each well of plate exactly below the optical path of each channel. The plate carrier is moved by a well controlled stepper motor drive.

6.9. Plate Loading & Pipetting Procedure

Control and sample pipetting procedure in case of cut off:

Maximum number of Blanks = 5

Maximum number of Controls:

1. Negative Control = 05

2. Positive Control = 05

3. Cut of control = 05

4. Low Positive Control = 05

Version 150511 PI number: 1701327 Page 21 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

Pipetting sequence should be as shown below.

6.10. Readings Check

Checking of readings should be done through controls reading within range specified in data sheet of controls (care should be taken while preparing and pipetting controls and reagents, reagent and control expiry dates need to be checked).

7. PRECAUTIONS

Do not use any sharp objects on the Touch Screen. Always use the STYLUS provided to operate the touch panel.

Always check for proper grounding before installation. Never operate the instrument when ground wire is removed.

3. Do not attempt to open the instrument and make repairs without proper technical

training. Do not allow unauthorized persons to operate or repair the instrument.

4. Use a clean plate and follow the instructions for blanking and standardizing. Do not

read any wells containing bubbles or dust particles.

5. The volume of sample, calibrators and blanks should be identical for correct readings.

The absorbance is proportionate to the path length. Pipetting should also be proper.

Version 150511 PI number: 1701327 Page 22 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

6. Monitoring of the printed values or displayed values during operation may help detect

an error. Check the linearity and calibration of the instrument regularly against some

standard reference.

7. Check the micro wells before use. They should be scratch-free. The micro well track in

the ELISA READER has been designed in such a way that the micro wells are totally

protected from scratches.

Recheck the reading of high OD (above 2A).

9. Place Plate carefully on the tray.

10. Ensure that the main power switch is in OFF position before connecting.

11. Plug the instrument to the AC mains. Confirm proper grounding for trouble

free operation.

12. Connect the printer only when the instrument is OFF.

8. PROGRAMMING MODES

We would like to highlight that the assay protocols reported in this section correspond to illustrations. When programming the instrument, the end-user must always refer to the instruction for use specific to each assay.

8.1. Absorbance Mode

In this mode the instrument gives only absorbance of all wells of plates of the respective plate.

Version 150511 PI number: 1701327 Page 23 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

Programming a New Test:

A. Select “Test Operation” B. Select “Add New Test”

MAIN MENU

1 Test Operations

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

ESC

TEST OPERATIONS

1 Select Test By Name ESC

2 Select Test by Mode

3 Select Test by Number

4 List Tests

5 Add New Test

C. Select mode of operation “Absorbance” in “Add new test”

1> Absorbance

Select Test Mode

0

0 2> Single Standard

3> Cut off 0

4> Multi Standard

5> Percent Absorbance

6> Uptake

7> Kinetic

0

0

0

0

D. Enter “Test Name”

NORM – ABSORBANCE

Name :

Pri : 405 Sec : 0

BL N ESC

NORM

MODE

DIFF

NORM – ABSORBANCE

Name:

ABS 560

A B C D E F G H

I J K L M N O P ENTER

Q R S T U V W X CLEAR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

Version 150511 PI number: 1701327 Page 24 of 117

U s s e r M a n u a l l E L I I S A P L A T E R E A D E R

5. Select primary and secondary filter

E. Select primary and secondary filter

NORM – ABSORBANCE

Name: ABS560 BL N ESC

Pri : 405 Sec : 0

NORM

MODE

DIFF

F. If blank is required select ”BL”

NORM – ABSORBANCE

Name : ABS560 BL Y ESC

Pri : 405 Sec : 0

NORM

MODE

DIFF

Pri: 560

Sec: 0

Select Filter Val:

0 405 450

492 630 NA

NA 560 YYY

ESC

If you select “BL Y”, it will read first well first strip ‘A1’ as a blank and subtract the absorbance of blank well from all other well’s absorbance.

G. In absorbance mode there are two modes of operations

Normal Absorbance Mode: Instrument gives the absorbance of each and every well.

Select touch zone “NORM”.

Differential Absorbance Mode: Instrument shows the difference of absorbance between odd number wells and even number wells. For Example,- Strip 1,- Strip 2, - Strip 3, - Strip 4, - Strip

5, -Strip 6. For this Mode select touch zone “DIFF”.

In Normal Mode

NORM – ABSORBANCE

Name: BL N ESC

Pri : 405 Sec : 0 SAVE

NORM

MODE

DIFF

Version 150511

In Differential Mode

DIFF – ABSORBANCE

Name: ESC

Pri : 405 Sec : 0 SAVE

NORM

MODE

DIFF

PI number: 1701327 Page 25 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

8.2. Single Standard

In this mode the instrument accepts the calibrator singly or in duplicate and then calculates the concentration based on the single point standard curve passing through the point 0.000

A single calibrator/standard of a known concentration is used to calibrate the instrument so that the concentration of unknown samples can be calculated according to Beer’s Law. The absorbance are read at user selected wavelengths. If Blank is selected, instrument will automatically blank on the first well and subtract its absorbance from each subsequent well.

The second well is treated as the calibrator/standard well. The third well is also treated as calibrator/standard well if the calibrator/standard is in duplicate.

CALCULATION:

Sample Concentration = (Calibrator concentration /Calibrator Abs.) x Sample Abs

CALCULATION:

Sample Concentration = (Calibrator concentration /Calibrator Abs.) x Sample Abs

Name: SIN_560

Pri: 560 Sec: 0

SINGLE STANDARD

BL Y 0.000 CAL 1 ESC

HI CO : N

DUP N DUP N SAVE

High> Low<

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Entry of all the parameters is similar to Multi standard mode (Please refer Multi standard for entry of parameters)

Version 150511 PI number: 1701327 Page 26 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

8.3. Cut Off Mode

In this mode cut-off point is determined for interpretation of specimens as per formula given in the reagent manual. The negative controls are read followed by the positive controls, Cut-off control, low positive control. Blanking on the first well is optional. The instrument calculates the average of the negative controls and the average of the positive control, Cut-off controls and Low positives are also calculated.

Programming a New Test:

A. Select “Add New Test”

TEST OPERATIONS ESC

1 Select Test By Name

2 Select Test by Mode

3 Select Test by Number

4 List Tests

5 Add New Test

B. Select mode of operation “Cut-Off” in “Add new test”

Select Test Mode

0 1> Absorbance

2> Single Standard

3> Cut off

4> Multi Standard

5> Percent Absorbance

6> Uptake

7> Kinetic

0

0

0

0

0

0

Version 150511 PI number: 1701327 Page 27 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

C. Entry of test name

Select touch Zone “Name:”

Name:

Pri: 450 Sec: 0

No Factor QC

BL 0 N

NC 0 1.000 N

PC 0 1.000 N

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

Alphanumerical characters will appears on the screen as shown below after touching “Name” on the screen. Enter the name of the test by selecting the individual characters one by one. After selecting all the characters select Enter option in touch screen for confirmation of test Name.

Name:

HBSAG

POS- CutOff

A B C D E F G H

I J K L M N O P ENTER

Q R S T U V W X CLEAR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

Version 150511 PI number: 1701327 Page 28 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

D. Selection of Primary and secondary filters.

Select zone “Pri:” on the touch screen

Name: HBSAG

Pri: 405 Sec: 0

No Factor QC

BL 0 N

NC 0 1.000 N

PC 0 1.000 N

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

Pri: 405

Sec: 560

Select Filter Val:

0 405 450

492 630 NA

NA 560 YYY

ESC

Select the required filters either Monochromatic or Bichomatic by selecting the filter values from

‘Select Filter Val’ region

E. According to the reagent manual change Blank, NCs, PCs to ‘YES’ for QC check.

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 0 N

NC 0 1.000 N

PC 0 1.000 N

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

QCVal Mes. Rem SAVE

POS- CutOff

ESC

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

Version 150511 PI number: 1701327 Page 29 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

F. Entry of Blank and Blank QC values

Select “BL” to enter blank details.

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 0 Y

NC 0 1.000 Y

PC 0 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.000 0.000

0.000 0.000

0.000 0.000

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

G. After selecting “BL”, enter total number of blanks by selecting No. of Blanks. (Maximum

5 blank).

No. of Blanks = 1

Values Of BL <= 0.000

Numeric Value: 1

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

H. Enter the QC value of the blank by selecting the touch Zone “Values of BL <=”

No. of Blanks = 1

Values Of BL <= 0.000

Numeric Value: 0.100

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Version 150511 PI number: 1701327 Page 30 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

I. Entry of Negative control and its QC values

Select touch Zone “NC”

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

NC 0 1.000 Y

PC 0 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

Enter N° of Negative controls by selecting touch Zone “N°of NC’s” (maximum 5 Negative

Controls). Enter the QC value of the Negative Control by selecting the touch Zone “Value of

NC” and enter the value of X given in the reagent manual by selecting Zone “Values Of X”.

No. of NC’s = 3

Values Of X = 1.000

Value of NC <= 0.150

Numeric Value

1 2 3 4 5 6 ENTER

Version 150511 PI number: 1701327 Page 31 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

K. After the entry of N° of NC’s Select ESC. The below screen will appear on the display.

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

NC 3 1.000 Y

PC 0 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

0.150

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

L. Entry of Positive Controls (PC).

Select touch Zone “PC”.

Name: HBSAG

Pri: 450 Sec: 630

No Factor QC

BL 1 Y

NC 3 1.000 Y

PC 0 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

0.150

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

Version 150511 PI number: 1701327 Page 32 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

M. After selecting No. of PC’s the screen below will appear on the display. Enter number of

Positive Controls by Selecting Zone “No. of PC’s” (Maximum 5). Enter the QC value of the

Positive Control by selecting the touch Zone “Value of PC >=” and enter the value of Y given in the reagent manual by selecting Zone “Values Of Y”.

No. of PC’s = 2

Values Of Y= 1.000

Value of PC >= 0.500

Numeric Value:

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

N. After entering the details of PCs, escape from the screen by selecting “ESC”. Below screen will appear on the display:

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

NC 3 1.000 Y

PC 2 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

0.150

0.500

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

NOTE: Same way you can enter values for LC (lower positive controls) and CC (Cut of

Controls).

Version 150511 PI number: 1701327 Page 33 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

O. Entry of Cut off Factor:

Select touch Zone “CUT FAC”

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

NC 3 1.000 Y

PC 2 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

0.150

0.500

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

After selecting the “CUTFAC” following screen will come on the display:

After selecting the “CUTFAC”, it will display following screen.

ESC

Value of Cut Factor = 0.000

ESC

Value of Cut Factor = 0.200

Numeric Value:

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Enter the Value for Cut Off Factor and select ESC

option to come out to the test parameter screen.

Version 150511 PI number: 1701327 Page 34 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

P. Entry of Cut off absorbance equation:

Select touch Zone “CUTABS”

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

NC 3 1.000 Y

PC 2 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

0.150

0.500

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

After selecting the “CUTABS” below screen will come on the display.

CUTABS: ESC

For entering the CUTABS equation, user has to

CUTABS: ESC

CUT ABS = NC + PC + CF

NC PC LC CC CF ENTER

+ -

1 2

7 8

(

Sqrt Lg ALg

,

3

9

Ln

*

4

0

ALn

%

5

.

Abs

CLEAR

6

) select ESC option in order to come out of the CUTABS screen.

Whereas, NC = Mean of NCs * Factor X Sqrt = Square root

PC = Mean of PCs * Factor Y Lg = LOG Aln = Anti Natural LOG

LC = Mean of LCs * Factor W

CC = Mean of CCs * Factor Z

CF = Cut off Factor

Ln = Natural LOG

Abs. = any absolute value

ALg = Anti LOG

Version 150511 PI number: 1701327 Page 35 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

For Example :

For equation CUT OFF ABS = (0.45 * NC) + (0.35 * PC) + 0.10, the formula can be entered in two ways.

1. Enter the values as it is i.e. CUTABS = (0.45*NC) + (0.35*PC) + 0.010. Keep the multiplication factors X, Y, W, Z of controls NC, PC, CC and LC a constant number ‘01’. (Numbers, mathematical functions and symbols for NC, PC, CC, LPC can be selected from the screen).

OR

2. In second method the formula can be entered as CUT ABS = NC + PC + CF. (Since the Value of

X, Y, Z, W is entered in the QC option of NC, PC, CC, LPC and Cut off factor in the CUT FAC option, there is no need to enter the same data again). Means here Multiplication Factor for NC =

X = 0.45

Multiplication factor for PC = Y = 0.35 and the value of cut of factor = CUT FAC = 0.100.

This is because here NC = Mean of NCs * Factor X, PC = Mean of PCs * Factor Y as mentioned above.

If ‘CUTOFF ABS’ = (NC + PC) / 6. This can be entered as it is CUTABS = (NC + PC) / 6 by keeping the multiplication factors X, Y, W, Z of controls NC, PC, CC and LC a constant number

‘01’.

OR

As you know in mathematics (NC + PC) / 6 = (NC / 6) + (PC / 6) =

(1/6) * NC + (1/6) * PC = (0.166 * NC) + (0.166 * PC),

So, you can enter same equation as CUT ABS = NC + PC, by entering

Multiplication Factor for NC = X = 0.166, multiplication factor for PC = Y = 0.166.

This is because here NC = Mean of NCs * Factor X, PC = Mean of PCs * Factor Y as mention above.

_______________________________________________________________________________

Version 150511 PI number: 1701327 Page 36 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Q. QC1, QC2, QC3 & QC4. can be used for any QC Checking of the test provided in reagent

manual.

For example some kit may give QC check equation like| PCx – NCx |> 0.500,

PC / NC > 15, etc. This equation can be entered by selecting these QC options. Select touch zone

‘N’. You will obtain ‘Y’, as shown in screen below by selecting touch zone ‘QC1’ and entering

QC equation.

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

NC 3 1.000 Y

PC 2 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

POS- CutOff

QCVal Mes. Rem SAVE

0.100

0.150

0.500

CUTABS: (

0.45 * NC) + (0.35 * PC) + 0.10

QC1 > Y

QC2 N

QC3 N

QC4 N

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

ESC

Version 150511 PI number: 1701327 Page 37 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Enter equation of QC and value of QC check by selecting touch zone ‘QC1 Value’ and ‘QC1 equat’.

Enter QC Value and Equation:

QC1 Value: 0.000 ESC

Enter QC Value and Equation:

QC1 Value: 0.500

QC1 Equat :

QC1 Equat :

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Enter QC Value and Equation:

QC1 Value: 0.000

QC1 Equat

ESC

QC Equat: PC – NC

NC PC LC CC

* + - ,

1 2 3 4

7 8 9

(

0

Sqrt Log ALog Ln

SA

%

5

.

ALn

ENTER

CLEAR

6

)

Abs

Same way you can enter QC equations for QC2, QC3 and QC4.

*NOTE:

On screen it is mentioned that “QC1 > Y”. In most of the reagent inserts it is mentioned that QC value should be greater than some constant value. Sometimes in the box insert it is mentioned that the value should be less than some constant value. In such case, you can change the symbol from

“QC1 > Y” to “QC1 < Y”, only by selecting a symbol of comparison.

If any QC check is selected to ‘YES’ option, the system will not save the test without entering the

QC equation and QC check value of equation.

Version 150511 PI number: 1701327 Page 38 of 117

U s s e r M a n u a l l

Enter % Value: ESC

E L

I

I S A P L A T E R

E

A

D

E

R

R. Interpretation of samples

Enter RANGE for interpretation of results either in percentage (Greyzone) or positive and negative values of INDEX, as a ratio of (Sample Abs. / Cutoff Abs.). If Cutoff Index range or Greyzone is not mentioned do not enter any values. Instrument will do the interpretation with references to the

Cut off absorbance.

R.1. Interpretation by GREYZONE percentage

Select touch zone ‘Greyzone % (N)’

Select touch zone ‘Greyzone % (N)’

Name: HBSAG

Pri: 405 Sec: 560

No Factor QC

POS- CutOff

ESC

BL 1 Y

NC 3 1.000 Y

PC 2 1.000 Y

QCVal Mes. Rem SAVE

0.100

0.150

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500

0.500

Interpretation :

QC2 N

QC3 N

QC4 N

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

If you enter ‘Greyzone’ percentage

‘10.00’, instrument will show you the same as shown in screen. It makes the ‘Cutoff Index Range’ option ‘NO’. This means when you are using a ‘Greyzone’ option the

‘Cut off Index Range’ option will not work.

Enter % Value :

% Value = 10.00

Numeric Value :

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Enter Greyzone percentage value

Select ESC option after entering Greyzone % value to come out to the parameter screen.

Version 150511 PI number: 1701327 Page 39 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

NOTE: If you don’t select any option for interpretation of sample results, the instrument will

take Cutoff Absorbance as a reference.

It will give “Positive’ remark to sample absorbance greater than cutoff and ‘Negative’

to sample absorbance less than cutoff.

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

NC 3 1.000 Y

PC 2 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

0.150

0.500

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500 Interpretation :

QC2 N

QC3 N

QC4 N

Greyzone % (Y) 10.00

Cut off Index (N)

Range

Version 150511 PI number: 1701327 Page 40 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

R.2. Interpretation by ‘Cutoff Index Range”

It is also provided to do the interpretation using ‘Cutoff Index’ by entering normal range for

‘Positive’ and ‘Negative’.

Name: HBSAG

Pri: 405 Sec: 560

No Factor QC

BL 1 Y

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

NC

PC

LC

CC

3

2

0

0

1.000 Y

1.000 Y

1.000 N

1.000 N

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500

QC2 N

QC3 N

QC4 N

0.150

0.500

Interpretation :

Greyzone % (N)

Cut off Index (Y)

Range Pos : 0.000

Neg : 0.000

Cut off Index is the ratio of

Sample Absorbance / Cut off

Absorbance.

When you select ‘Cutoff Index’

–‘Y’, the ‘Greyzone %’ will become ‘NO’, means inactive.

In ‘Cutoff Index’, provide the range for interpretation, the positive and negative value of ratio (Sample Abs. / Cutoff Abs.)

RESULT RANGE: ESC

POSITIVE >= 0.000

NEGATIVE <= 0.000

In case of ‘Cutoff Index Range ’,

RESULT RANGE: ESC

POSITIVE >= 1.000

NEGATIVE <= 0.000

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

It gives the ‘Positive’ remarks to sample having index value, a ratio of …

(Sample abs. / Cutoff Abs.) greater than or equal to entered ‘POSITIVE’ value and it gives ‘Negative’ remarks to sample having index value, a ratio of

(Sample abs. / Cutoff Abs.) less than entered ‘NEGATIVE’ value.

The sample having index value in between ‘POSITIVE’ and ‘NEGATIVE” range get remarks

‘Equivocal’ = ‘EQ’.

Version 150511 PI number: 1701327 Page 41 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

After entering the Interpretation values (ie. conditions for interpretation) the screen will be displayed as follows –

Name: HBSAG

Pri: 405 Sec: 560

No Factor QC

BL 1 Y

NC 3 1.000 Y

POS- CutOff

ESC

QCVal Mes. Rem SAVE

0.100

0.150

0.500 PC 2 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500 Interpretation :

QC2 N

QC3 N

QC4 N

Greyzone % (N)

Cut off Index (Y)

Range Pos : 1.000

Neg : 0.900

For example:

If you enter POS >= 1.0 and NEG

<=0.9.

Then, the sample will get

POSITIVE remarks having INDEX

Value,

(Sam. Abs./ Cutoff Abs.) >= 1.000.

The sample will get NEGATIVE remarks having INDEX Value,

(Sam. Abs./ Cutoff Abs.) <= 0.900.

The sample will get EQUIVOCAL remarks having INDEX Value,

(Sam. Abs./ Cutoff Abs.) in the range from 0.900 to 1.000.

S. To save the test after entering all the parameters, select ‘SAVE’ option.

Name: HBSAG

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

NC 3 1.000 Y

PC 2 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

POS- Cut Off

ESC

QCVal Mes. Rem SAVE

0.100

0.150

0.500

CUTABS: NC + PC + CF

QC1 > Y 0.500 Interpretation :

QC2 N Greyzone % (Y) 10.00

QC3 N

QC4 N

Cut off Index (N)

Range

Version 150511 PI number: 1701327 Page 42 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

8.4. Reverse Cut Off Mode

For Reverse Cut Off mode, select touch zone ‘POS’- Cut off key. It will change to REV- Cut Off.

Name:

Pri: 450 Sec: 0

No Factor QC

BL 0 N

NC 0 1.000 N

PC 0 1.000 N

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N

QC2 N

QC3 N

QC4 N

REV- CutOff

ESC

QCVal Mes. Rem SAVE

Interpretation :

Greyzone % (Y) 10.00

Cut off Index (N)

Range

In Reverse Cut Off Mode, programming of test is the same as Positive Cut off Mode. Only QC check conditions for blanks and controls get reversed. In the ‘INTERPRETATION’, sample absorbance, which is lesser than cut off absorbance, gets remarked POSITIVE . Sample absorbance higher than cut off absorbance, gets remarked NEGATIVE. This is exactly the opposite to normal

POSITIVE Cut Off Mode. Same way in case you select ‘Cutoff Index Range’.

Version 150511 PI number: 1701327 Page 43 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

8.5. Multi Standard Mode:

In this mode the instrument accepts a maximum of 12 calibrators and calculates concentration based

on the best-fit curve. Graph is printed with Absorbance on Y-axis and concentration on Xaxis.

Programming a New Test:

A. Select Main Menu/Test Operation/Add New Test B. Select Touch Zone “Multi Standard”

TEST OPERATIONS

1 Select Test By Name

2 Select Test by Mode

3 Select Test by Number

4 List Tests

5 Add New Test

ESC

Select Test Mode ESC

0 1> Absorbance

2> Single Standard

3> Cut off

0

0

4> Multi Standard

5> Percent Absorbance

6> Uptake

7> Kinetic

0

0

0

0

After selecting Multistandard mode it will display following screen -

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL N

DUP N

CAL 2 ESC

DUP N

HI CO : N High> Low<

SAVE

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

Version 150511 PI number: 1701327 Page 44 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

C. Entry of Test Name

Test Name can be entered by Selecting Touch Zone “Name:”

Procedure for entering the test name is the same as the one of cut off mode. Refer Test Name entry in Cut off mode for further details.

D. Selection of Primary and secondary filters

Select Touch Zone “Pri:”

Name: MUL_4P MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

HI CO : N High> Low<

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

Pri: 405

Sec: 0

Pri: 560

Sec: 0

Select Filter Val:

0 405 450

492 630 NA

NA 560 YYY

ESC

ESC

Select the Filters as per details given in the reagent manual

Version 150511 PI number: 1701327 Page 45 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

E. Selection of Blank

Select Touch Zone “BL”

Select Touch Zone “BL”. Instrument will display the message “Blank required Yes/No” at the bottom of the Screen, select “Yes” if blank is required.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

HI CO : N High> Low<

SAVE

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL N CAL 2 ESC

DUP N

HI CO : N High> Low<

DUP N

SAVE

LO CO: N High> Low<

Interpret’n : N Range High>

Low<

Graph : LINEAR

Blank Required ? YES / NO

F. Entry of Standard Concentration

Select touch Zone “CAL” to enter Number of calibrators and its concentration.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 2 ESC

DUP N DUP N

SAVE

HI CO : N High> Low<

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

After selecting “CAL”, it will display following screen:

Select Touch Zone “No. Of Calibrators”. Numeric screen will be displayed at the bottom of the screen.

Select the number of calibrators (User can select min 2 and max. 12 standard in this mode).

Version 150511 PI number: 1701327 Page 46 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Whereas in case of 4 Parameter, user can select min. 5 and max.12 calibrators.

No Of Calibrator: 2

No Conc Abs

1 0.000 0.000

2 0.000 0.000

ESC No Of Calibrator: 2

No Conc Abs

1 0.000 0.000

2 0.000 0.000

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

ESC

Concentration Entry:

After entering the number of calibrators, concentration and absorbance column will come on the display as shown below.

To enter concentration values select 0.000 in Conc. column corresponding to the standard and enter the concentration value. e.g. for entering Concentration of standard 4 Select 0.000 in fourth row of

Conc. Column and enter the concentration by selecting the numerals.

(Note: The concentration value should be either in ascending or descending order.)

No Of Calibrator 7 ESC

No Conc Abs No Conc Abs

1 0.000 0.000 7 10.00 0.000

2 0.500 0.000

3 1.000 0.000

4 2.500 0.000

5 5.000 0.000

6 7.500 0.000

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Version 150511 PI number: 1701327 Page 47 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Screen after entry of calibration will be displayed as follows -

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP N DUP N

SAVE

HI CO : N High> Low<

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

G. Selection of Duplicate Blank and calibrators

For Duplicate Blank:

Select touch zone “DUP” below the “BL Y” After selecting “DUP” instrument will display message “Duplicate Blank? Yes/ No” as shown below. Select “Yes” for Duplication of Blank.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP N DUP N

HI CO : N High> Low<

SAVE

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP N DUP N

HI CO : N High> Low<

SAVE

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Duplicate Blank?

YES / NO

Version 150511 PI number: 1701327 Page 48 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

For Duplicate Calibrators:

To select Duplicate Calibrator select Touch Zone “DUP” below the “CAL 7”. After selecting

“DUP” instrument will display message “Duplicate Calibrator? Yes/No” as shown below. Select

“Yes” for Duplication of calibrators.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y

HI CO : N High> Low<

DUP N

SAVE

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP N

HI CO : N High> Low<

SAVE

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Duplicate Calibrator?

YES / NO

Screen after standard entry & selection of duplicate – Blank & Calibrators.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y

SAVE

HI CO : N High> Low<

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

Version 150511 PI number: 1701327 Page 49 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

H) Graph type along with its scales:

There are three types of graphs in Multistandard. They are mentioned as follows -

1. Linear (LINEAR)

2. Point to Point (PT TO PT)

3. 4 Parameters

There are five types of scales for X and Y axis

LOGABS vs CONC (X-axis = Concentration v/s Y-axis = LOG of ABS.)

ABS vs LOGCONC (X-axis = LOG of concentration v/s Y-axis = Absorbance)

LOGITABS VS LOGCONC (X-axis = LOG of concentration v/s Y-axis = LOGIT of Absorbance)

ABS vs CONC (X-axis = Concentration v/s Y-axis = Absorbance)

LOGABS vs LOGCONC (X-axis = LOG of concentration v/s Y-axis = LOG of absorbance)

Selection of Graph

Select Graph type as per the details given in the reagent manual by selecting Touch Zone “Graph”.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y

HI CO : N High> Low<

SAVE

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : LINEAR

Y vs X : ABS vs CONC

Version 150511 PI number: 1701327 Page 50 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

1. Linear mode graph type:

After Selecting the “Graph” follow screen will come on the display.

Select Graph type as Linear.

Select scale as per the details given in the reagent manual.

Graph : LINEAR ESC

Y vs X : ABS vs CONC

TYPE

LINEAR

SCALE

LOGABS vs CONC

ABS vs LOGCONC

PT TO PT LOGITABS vs LOGCONC

ABS vs CONC

4 PARAMETER LOGABS vs LOGCONC

2. Point to Point Graph Type:

Select touch zone “PT to PT” abs scale of graph ‘ABS vs. CONC’.

Graph Type : PT TO PT

Y vs X : ABS vs CONC

TYPE SCALE

LINEAR LOGABS vs CONC

PT TO PT

ABS vs LOGCONC

LOGITABS vs LOGCONC

ABS vs CONC

4 PARAMETER LOGABS vs LOGCONC

ESC

3. 4 Parameters Graph Type:

Select touch zone “4 Parameters” & abs scale of graph as ‘ABS vs. CONC’. Remember that it's default scale type is “ABS vs CONC”.

Graph Type : 4 PARAMETER

Y vs X : ABS vs CONC

TYPE SCALE

ESC

LINEAR LOGABS vs CONC

ABS vs LOGCONC

PT TO PT LOGITABS vs LOGCONC

Version 150511

ABS vs CONC

4 PARAMETER LOGABS vs LOGCONC

PI number: 1701327 Page 51 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Select the scale type touching the required zone.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y

SAVE

HI CO : N High> Low<

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : 4 PARAMETER

Y vs X : ABS vs CONC

I. Selection of Controls

For High control select touch zone ‘HI CO: N’ Following message appears: “High Control

Required? Yes / No”. Select ‘YES’ and then enter range of control “HIGH” and “LOW”.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y

HI CO : N High> Low<

SAVE

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : 4 PARAMETER

High Control Required

?

YES / NO

Version 150511 PI number: 1701327 Page 52 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Enter range of control “HIGH” and “LOW” as per reagent manual.

Enter High Range Value:

High 0.000

Low 0.000

ESC Enter High Range Value:

High 25.03

Low 10.54

ESC

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Similarly, for Low Control select touch zone ‘LO CO: N’ It will display the message “Low Control

Required? Yes / No”. Select ‘YES’ and then enter range of control “HIGH” and “LOW”.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y

SAVE

HI CO : N High> 25.03 Low< 10.54

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

Graph : 4 PARAMETER

Low Control Required

?

YES / NO

(Note: Entry of LO CO is similar to that of HI CO)

Version 150511 PI number: 1701327 Page 53 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

J. Normal Range selection for interpretation of samples:

For interpretation of specimen result (POSITIVE or NEGATIVE), enter normal range given in

REAGENT MANUAL. Select “Interpretation: N”. It will change to “Interpretation: Y”. Then select “HIGH>” and “LOW<” to enter normal range.

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y

SAVE

HI CO : Y High> 25.03 Low< 10.54

LO CO: Y High> 16.61 Low< 5.45

Interpret’n: Y Range High> 0.000

Low< 0.000

Graph : 4 PARAMETER

Y vs X : ABS vs CONC

All the results whose concentration is coming above the High Range will be considered as positive and coming below the Low Range will be consider as negative.

The results having concentration in between High and Low range will get remarks ‘Equivocal’ = ‘EQ’.

Enter Normal Range for positive and negative samples.

Enter HIGH Range value:

High> 0.000

Low< 0.000

ESC

Enter HIGH Range value:

High> 15.25

Low< 9.46

Numeric Value

ESC

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

After entering all the parameters save the test by selecting “SAVE” option.

Version 150511 PI number: 1701327 Page 54 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Name: MUL_4P MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y

SAVE

HI CO : Y High> 25.03 Low< 10.54

LO CO: Y High> 16.61 Low< 5.45

Interpret’n: Y Range High> 15.25

Low< 9.46

Graph : 4 PARAMETER

Y vs X : ABS vs CONC

(*Same way you can make a test for Single standard, % Absorbance and uptake)

8.6. Percentage Absorbance

The Percentage Absorbance Mode requires one calibrator (read singly or duplicate). In this mode, calibrator is considered to have a concentration of 100%. The absorbance’s of unknown samples are read and compared to the calibrator absorbance, and reported as % concentration of calibrator.

Refer 8.5 for parameter entry.

Name: % ABSORBANCE

Pri: 405 Sec: 0 BL Y 0.000 CAL 1 ESC

DUP N DUP N

SAVE

HI CO : N High> Low<

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

8.7. Uptake

In this mode the instrument accepts the calibrator singly or in duplicate and then calculates the concentration based on the single point standard curve passing through the point 0.000

A single calibrator/standard of a known concentration is used to calibrate the instrument so that the concentration of unknown samples can be calculated according to Beer’s Law

Sample Concentration = Calibrator Absorbance * Calibrator Concentration

Version 150511 PI number: 1701327 Page 55 of 117

U s s e r M a n u a l l

Sample Absorbance

Name: UPTAKE

Pri: 405 Sec: 0 BL N CAL 1 ESC

DUP N DUP N

E L

I

I S A P L A T E R

E

A

D

E

R

LO CO: N High> Low<

Interpret’n: N Range High>

Low<

8.8.

Kinetic

After entering Test Name and Filter values, select Read Time and Read Period

KINETIC

Name: KIN_560 ESC

SAVE Pri: 560 Sec: 0

Read Time: 1 min.

Read Period: 15 sec.

KINETIC

Name: KIN_560

Pri: 560 Sec: 0

Read Time: 1 min.

ESC

SAVE

KINETIC

Name: KIN_560

Pri: 560 Sec: 0

Read Time: 1 min.

Read Period: 15 sec.

Numeric Value

ESC

SAVE

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

“Read Time” is total read period of the whole test.

You need to enter it only in minutes.

Read Period: 15 sec.

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

“Read Period” is time interval between two readings.

User must enter it in seconds.

Version 150511 PI number: 1701327 Page 56 of 117

U s s e r M a n u a l l

E L

I

I S A P L A

Finally select the “Save” option in order to save the test in KINETIC mode

T E R

E

A

D

E

R

Name: KIN_560

KINETIC

Pri: 560 Sec: 0

Read Time: 1 min.

Read Period: 15 sec.

ESC

SAVE

9. RECALLING AND RUNNING OF STORED

TEST/PROGRAMS

MAIN MENU

TEST OPERATIONS

1 Test Operations ESC

1 Select Test By Name

2 Technical Diagnosis

2 Select Test by Mode

3 Utilities

3 Select Test by Number

4 View Plate

4 List Tests

5 Serial Communication

5 Add New Tests

Test can be recalled by Name, Mode, Number or by List test.

ESC

The entire saved tests are available on the List Test or on the first screen after initialization.

User can directly RUN the test by selecting RUN option present on the screen.

TEST OPERATIONS

1 Select Test By Name ESC

2 Select Test By Mode

3 Select Test By Number

4 List Tests

5 Add New Tests

Select Test

1 HBSAG

ESC

RUN / SEL

2 TSH PRNT

3 HCV NXT

4 MUL_4P PREV

5 CP_560 DEL

PLATE

DATA

Version 150511 PI number: 1701327 Page 57 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Tests can be selected with the help of SEL option present on the Select Test screen in order to

EDIT / PRINT the test parameters entered before saving the test.

Select Test ESC

1 HBSAG RUN / SEL

2 TSH PRNT

3.HCV NXT

4 MUL_4P PREV

5 CP_560 DEL

PLATE

DATA

NORM – ABSORBANCE

Name : HCV BL N ESC

EDIT Pri : 450 Sec : 560

NORM

MODE

RUN

DIFF PRINT

9.1. Absorbance Mode:

Select the test and point to RUN option

TEST OPERATIONS

1 Select Test By Name ESC

2 Select Test By Mode

3 Select Test By Number

4 List Tests

5 Add New Tests

On selecting RUN option it will display following screen.

Select Test

1 HBSAG

ESC

M

2 TSH S

RUN / SEL

PRNT

3. HCV A NXT

4 MUL_4P M PREV

5 CP_560 C DEL

PLATE

DATA

The instrument will ask “Is Plate Loaded? YES / NO”, select ‘Yes’. Instrument will read the absorbance using mechanical plate movement. After completion of reading it will ask:

“Is Plate Removed? YES / NO”. Remove the plate and Select ‘YES’.

Name: HCV NORM – ABSORBANCE

Pri : 450 Sec : 560 BL N

ABS ABS ABS ABS ABS ABS

1 2 3 4 5 6

ABS ABS ABS ABS ABS ABS

7 8 9 10 11 12

Is Plate Loaded ? YES / NO

Version 150511

Name: HCV NORM – ABSORBANCE

Pri : 450 Sec : 560 BL N

ABS ABS

1 2

ABS

3

ABS

4

ABS

5

ABS

6

ABS ABS ABS ABS ABS ABS

7 8 9 10 11 12

Is Plate Removed ? YES / NO

PI number: 1701327 Page 58 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Details of absorbance of all wells in table format for each strip will be displayed on the screen as shown below.

In this operation if you keep BLANK

Name: HCV NORM – ABSORBANCE

Pri : 450 Sec : 560 BL N

ABS ABS ABS ABS ABS ABS

1 2 3 4 5 6

0.028 0.145 0.100 0.017 0.089 0.135

-- --

--

--

--

0.071 0.123 0.113 0.054 0.116 0.060

ABS ABS ABS ABS ABS ABS

7 8 9 10 11 12

0.362 0.078 0.410 1.440 0.746 0.224

-- --

--

--

--

0.112 0.111 0.093 2.568 0.396 0.015

ESC PRINTMATRIX SEND PLATE LOAD NEXT

YES

The first well of first strip will be considered as blank and instrument will give the absorbance of remaining all well with blank subtraction from original absorbance.

The “PRINT MATRIX” will print the details of entire plate with well identification and absorbance of that well, like…..

A

W1 W2 W3 W4 W5 W6

0.125 0.250 0.350 0.450 0.550 0.650..

Using “SEND PLATE” plate data can be sent to computer using either USB or

SERIAL RS232.

“LOAD NEXT” is used to load the Next

Plate in order to get the absorbance of next plate

Version 150511 PI number: 1701327 Page 59 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Example Print-out of ABSORBANCE test obtained from ELISA Reader

After running the plate in Absorbance mode, user can take the print of the result in the form of

Print matrix which will be printed as follows –

Version 150511 PI number: 1701327 Page 60 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Differential Absorbance Mode: In differential absorbance mode the instrument will give the absorbance difference each set of “ODD” number strip and EVEN number strip.

Name: ABS DIFF– ABSORBANCE

Pri : 560 Sec : 0

ABS ABS ABS ABS ABS ABS

1 2 3 4 5 6

0.900

0.200

0.300

1.700 0.900

1.000 1.800

1.100 1.900

0.400

0.500

0.600

0.700

1.200

1.300

1.400

1.500

2.000

2.100

2.200

2.300

0.800 1.600 2.400

ABS ABS ABS ABS ABS ABS

7 8 9 10 11 12

0.100

0.200

0.300

0.400

0.500

0.600

0.700

0.800

0.900

1.000

1.100

1.200

1.300

1.400

1.500

1.600

1.700

1.800

1.900

2.000

2.100

2.200

2.300

2.400

ESC PRINTMATRIX SEND PLATE LOAD NEXT

It is showing the absorbance only for even number strips. This absorbance values are actually differences between each well of strip 1 and well of strip

2.You can get the difference between set of 1-2, 3-4, 5-6, 7-8, 9-10 and 11-12. It is not possible to change this combination.

In “PRINT MATRIX”, you will get the print of entire plate data with actual absorbance of each well and difference of absorbance between ODD well and

EVEN well, like

A

W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12

0.300 0.279 0.524 0.497 0.816 0.499 0.082 0.474 0.651 0.331 0.394 0.562

0.000 0.021 0.000 0.028 0.000 0.316 0.000 -0.391 0.000 0.320 0.000 -0.168

B

W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12

0.506 0.584 0.648 0.194 0.472 0.457 0.822 0.346 0.679 0.387 1.047 0.130

0.000 -0.077 0.000 0.453 0.000 0.015 0.000 0.476 0.000 0.292 0.000 0.918

Version 150511 PI number: 1701327 Page 61 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

9.2. Cut off Mode

After recalling the test saved in Cut-Off mode, it will display following screen.

User can take the print of the test parameters by selecting “PRNT” option present on the

screen. It will print all the details of the test parameters alongwith QC equations.

Name: HCV POS- Cut Off

Pri: 560 Sec: 0 ESC

No

BL 1

NC 2

Factor QC

Y

1.000 Y

PC

LC

2

0

1.000 Y

1.000 N

CC 0

CUTFAC: 0.100

1.000 N

QCVal Mes.

0.100

0.150

0.000

0.000

0.500 0.000

CUTABS: 0.1*PC+CF

QC1 N

QC2 N

Interpretation :

Greyzone % (Y) 10.00

QC3 N

QC4 N

Cut off Index (N)

Range

To change values press EDIT

EDIT

RUN

PRNT

A) For running the test in CUTOFF mode select the particular test and point to RUN option

present on the “List Test” screen.

Select Test ESC

1 HBSAG M RUN / SEL

2 TSH S PRNT

3 HCV C NXT

4 MUL_4P M PREV

5 CP_405 C DEL

PLATE

DATA

NC

NC

PC

PC

Name: HCV

Pri: 560 Sec: 0

No. of Samples: 0

POS- Cut Off

ESC

RUN

DUP N SIMUL PID

1 2 3 4 5 6 7 8 9 10 11 12

B

NC

Version 150511 PI number: 1701327 Page 62 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

B) It shows the 12 strips horizontal with 8 wells vertical with blanks and controls loaded in first strip. Select the ‘No. of Samples’ and enter the total Number of samples you want to load with the help of numeric screen displayed at the bottom of the screen.

Name: HCV

Pri: 560 Sec: 0

No. of Samples: 0

DUP N SIMUL

POS- Cut Off

ESC

PID

RUN

1 2 3 4 5 6 7 8 9 10 11 12

Name: HCV

Pri: 560 Sec: 0

No. of Samples: 10

DUP N SIMUL

POS- Cut Off

ESC

RUN

PID

1 2 3 4 5 6 7 8 9 10 11 12

B S3

NC S4

B

NC

NC

NC

PC

PC

Numeric Value: 10

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

NC S5

NC S6

PC S7

PC S8

S1 S9

S2 S10

C) After entering No. of samples, select RUN. The plate-loading tray will come out and the following message will appear: “Is plate loaded? YES / NO”

Name: HCV

Pri: 560 Sec: 0

No. of Samples: 10

DUP N SIMUL

POS- Cut Off

PID

ESC

RUN

1 2 3 4 5 6 7 8 9 10 11 12

B S3

NC S4

NC S5

NC S6

PC S7

PC S8

S1 S9

S2 S10

Is Plate Loaded ? YES / NO

Version 150511 PI number: 1701327 Page 63 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

D) Here the plate is loaded in the direction that controls should go in first. Select “YES”.

The instrument will read the controls and samples.

Following message appears: “Is plate removed? YES / NO”. Remove the plate and select YES.

Name: HCV

Pri: 560 Sec: 0

POS- Cut Off

No. of Samples: 10

DUP N SIMUL PID

ESC

RUN

1 2 3 4 5 6 7 8 9 10 11 12

B S3

NC S4

NC S5

NC S6

PC S7

PC S8

S1 S9

S2 S10

Is Plate Removed? YES / NO

E) After selecting YES, result screen will appear with the measured values of average blank, average of all controls and the cut off absorbance. To check the results of samples, select option ‘Display value’

Name: HCV

Pri: 560 Sec: 0

No Factor QC

POS- Cut Off

ESC

QCVal Mes. Rem ACCEPT

0.100 0.050 TEST BL 1 Y

NC 2 1.000 Y

PC 2 0.100 Y

0.150 0.098

0.500 2.658

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

QC1 2.560

Range % 10.00

QC2

QC3 QC4

CUTABS: 0.563

PRINT

Display

VALUE

LOAD

NEXT

Version 150511 PI number: 1701327 Page 64 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

F) ‘DISPLAY VALUE' option will display the result of all samples along with the controls

selected.

Name: HCV POS- Cut Off

Pri: 560 Sec: 0 BL Y

Range PERCENTAGE % 10.00

ESC

NXT

Pos: 0.330

CUT ABS= 0.300 Neg: 0.270 PREV

NO SAMP ABS AVG INDEX REM PID

A1 B 0.050 0.050

B1 NC

--

--

G1 S1 0.200 0.200 0.254 NEG PQR-1

H1 S2 1.854 1.854 7.245 POS PQR-2

PRINT

RESULTS

SAVE

RESULTS

PRINT

MATRIX

PLATE

OPT.

G) By selecting ‘ACCEPT TEST’ option you can save this test with the details of controls absorbance. Next time it is possible to run the same test without loading controls. This means that the previous stored values of controls can be used.

All the details are in table format, as per row and column shown on the screen. You can obtain the print of the same format by selecting option ‘PRINT RESULTS’. To check the results of next samples, choose option ‘NXT’, and then print it in format as shown on the screen by option ‘Print

Results’

You can obtain the print in matrix format, by selecting option ‘PRINT MATRIX’.

In matrix form you will get the print as per your tray/plate for all the wells. Instrument prints seven different parameters in print matrix for a single well.

ROW IDENTIFICATION

WELL NUMBER

WELL ID OR SAMPLE NUMBER

PATIENT IDENTIFICATION

WELL ABSORBANCE

SAMPLE CONCENTRATION

INTERPRETATION / REMARKS

A, B, C,D,……

W1, W2, W3, W4…..

BL, NC, PC, OR S1, S2, S3, …..

RAMESH, VIKAS, etc.

0.050, 0.098, 0.085, …

0.738, 0.689, 2.578,…

POS or NEG or EQ

Version 150511 PI number: 1701327 Page 65 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Example Print-out of POS-CUTOFF test obtained from ELISA

Reader

Version 150511 PI number: 1701327 Page 66 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

9.2. A. Invalid Assay in Cut Off Mode

If any individual control behaves incorrectly and it’s absorbance is not satisfying the QC check value of that control, the following message appears: “Invalid Assay” and a remark “HI” or “LO” for that particular control. OR if the QC1, QC2, QC3 and QC4, which has an other QC condition of controls (like some reagent manual gives condition PC-NC > 0.2 or NC/PC > 0.5) the following message appears: “Invalid Assay” and a remark either ‘HI’ or ‘LO’ for that QC condition.

Name: HBSAG

Pri: 560 Sec: 0

No Factor QC

BL 1 Y

POS- Cut Off

ESC

QCVal Meas. Rem ACCEPT

0.100 0.105 HI TEST

NC 3 1.000 Y

PC 2 0.100 Y

LC 0 1.000 N

Invalid Assay

0.150 0.200 HI

0.500 0.456 LO

CC 0 1.000 N

CUTFAC: 0.200

QC1 2.560 HI QC2

CUTABS: 0.563

QC3 QC4

PRINT

DISPLAY

VALUE

LOAD

NEXT

(NOTE: The absorbance of controls should not go above

3.50. If it is > than 3.50, it will show the remark ‘HI’ for that control. In such a case edit the control absorbance.)

In such case, delete an individual control, so that the average of remaining controls will satisfy the

QC condition of that control as per reagent manual.

To select any control for deleting, you must select the touch zone as shown in the above screen.

When you select any particular control for deleting (suppose you have selected Negative Control

(NC), ‘HI’ or ‘LO’ remark appear on the screen.

“Select EDIT / DEL key to proceed”. To delete the control select ‘DEL’. After deleting that control, the absorbance of that control will become zero and the average of controls will also get changed. Select ‘ESC’ option to come back to the Result screen.

Version 150511 PI number: 1701327 Page 67 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

NC VALUE :

NC1 0.150

0.200

NC2 0.350 HI

NC3 0.200 HI

ESC

DEL

When you go back, you will get the edited values for average of control with no remark for any control and no “Invalid Assay” message.

*NOTE:

Make the blank absorbance valid in case the absorbance doesn’t meet the QC conditions.

If necessary valid the control absorbance because the absorbance of the blank affect the absorbance of all controls and samples.

It is recommended that, for a test with single blank and single control, if absorbance doesn’t satisfy

QC conditions or if all controls of any single type (means all NC controls or all PC controls) doesn’t meet the QC, the test will become totally invalid. It is not possible to make the VALID

TEST and new controls have to be loaded.

Version 150511 PI number: 1701327 Page 68 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

9.3. Multistandard

After recalling the test in multistandard mode it will display following screen. Take the print of the

test parameters if required and select “Run” option. Or else you can directly run the test from the

List Test screen.

Multi Standard Mode

Name: TSH MULTISTANDARD

Pri: 450 Sec: 560 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y EDIT

RUN

HI CO: Y High> 25.03 Low< 10.54 PRINT

LO CO: Y High> 16.61 Low< 5.45

Interpret’n: Y Range High> 15.25

Low< 9.46

Graph: 4 PARAMETER

Y vs X : ABS vs CONC

To change values press EDIT

A) For running the test in MUL_STD mode select the particular test and point to RUN option present on the screen. On selecting RUN option it will display following screen.

Select Test

1. HBSAg

ESC

2. HCVAb M RUN / SEL

3. UPT

4. TSH

5. CPC C

6. PER_ABS P NEXT

7. CRP C

8. KIN_560 K PREV

9. SIN_630 S

10. CP_405 C DEL

PLATE

DATA

Name: TSH

Pri: 450 Sec: 560

No. of samples: 0

MULTISTANDARD ESC

RUN

DUP N SIMUL PID

1 2 3 4 5 6 7 8 9 10 11 12

B

C1

C2

C3

C4

C5

C6

C7

HI CO: 0 LO CO: 0

COL COL

ROW ROW

Version 150511 PI number: 1701327 Page 69 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

B) To enter total No. of HI controls, select “HI CO:” option and enter numeric value.

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

C) If you select No. of HI controls = 2, then you have to locate the position of HI controls by selecting column number and row number.

For column number entry select “COL” option and enter column number.

HI CO : 2

ROW COL

2

3

Please Enter Col Entry: 1

Numeric Value:

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

For row entry select “ROW” option and enter row position.

HI CO : 2

ROW COL

A 2

B 3

Please Enter Row Entry: 1

Row Entry:

A B C D E F G H ENTER

CLEAR

Similarly, you can enter No. of LO Controls and locate its positions.

Version 150511 PI number: 1701327 Page 70 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

D) You can locate Controls from first well or after last calibrator to last well of strip 12 in any test.

Suppose you select column 2 & row A for first HI control and column 2, row B for second HI control then the location of HI control will be display on screen as shown below.

Name: TSH

Pri: 450 Sec: 560

No. of samples: 0

DUP N SIMUL

MULTISTANDARD

PID

ESC

RUN

1 2 3 4 5 6 7 8 9 10 11 12

B HC

C1 HC

C2

C3

C4

C5

C6

C7

HI CO: 2

COL

ROW

E) Select No. of samples you want to run. In case of 10 samples, it will load 10 samples

as follows -

Name: TSH

Pri: 450 Sec: 560

No. of samples : 10

DUP N SIMUL

MULTISTANDARD

PID

ESC

RUN

1 2 3 4 5 6 7 8 9 10 11 12

B HC S5

C1 HC S6

C2 LC S7

C3 LC S8

C4 S1 S9

C5 S2 S10

C6 S3

C7 S4

HI CO: 2

COL

ROW

LO CO: 2

COL

ROW

Version 150511 PI number: 1701327 Page 71 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

F) Now Select RUN option so that readings can be taken in MULTI STANDARD mode.

The plate holder will come out and will display the message string- “Is Plate loaded YES / NO”.

The plate has to be loaded in such a way that the direction of the calibrators should go in first and then select ‘YES’.

The instrument will read the absorbance of calibrators and samples. And finally display the string-

“Is plate removed? YES / NO”. Remove the plate and select ‘YES'. The plate holder will go inside and following screen will be flashed on the display.

(Note: It takes maximum 6 min only in case of 4 parameter)

Name: MULTI STANDARD ESC

Pri: Sec: BL CAL NXT

DUP DUP PREV

Range High > Low <

HI CO : High > Low < SAVE

LO CO : High > Low < RESULT

NO SAMP ABS AVG CONC REM PID

Please Wait…………

It may take maximum 6 minutes.

LOAD PRINT PLATE VIEW ACCEPT PRINT

NXT MATRIX OPT. GRAPH TEST RESULTS

After reading it will display all the details of calibrators, samples and controls on the screen as shown below-

Name: TSH

Pri: 450 Sec: 560

MULTI STANDARD

BL Y CAL 7

ESC

DUP N DUP N

Range High > 15.25 Low < 9.46 NXT

HI CO : High > 25.03 Low < 10.54

LO CO : High > 16.61 Low < 5.45 PREV

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050

B1 C1 0.070 0.070 0.000

C1 C2 0.257 0.257 2.500

--

SAVE

RESULT

--

--

G1 S1 0.200 0.200 2.100 NEG TSH-1

H1 S2 1.854 1.854 9.845 POS TSH-2

LOAD PRINT PLATE VIEW ACCEPT PRINT

NXT MATRIX OPT. GRAPH TEST RESULTS

All the details as per row and column are shown on the screen. The printout of the same format can be obtained by selecting ‘PRINT RESULTS’. To check the results of next samples, select

‘NXT’ and print the format shown on screen by option ‘Print Results’.

Version 150511 PI number: 1701327 Page 72 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

You can get the print in matrix format, by selecting ‘PRINT MATRIX’.

In matrix form you will get the print as per your plate for all the wells. Instrument will print seven different parameters in print matrix for a single well as follows:

ROW IDENTIFICATION

WELL NUMBER

WELL ID OR SAMPLE NUMBER

PATIENT IDENTIFICATION

WELL ABSORBANCE

SAMPLE CONCENTRATION

INTERPRETATION / REMARKS

A,B, C,D,……

W1, W2, W3, W4…

B, C1, C2, C3, OR S1, S2, S3,..

LUCAS, DUPONT, etc.

0.050, 0.098, 0.085, …

0.738, 0.689, 2.578…

POS, NEG, EQ,

Remember that Negative sign result is interpreted as zero both in printout as well as on screen.

Version 150511 PI number: 1701327 Page 73 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Example Print-out of MultiStandard test obtained from ELISA Reader

Version 150511 PI number: 1701327 Page 74 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

G) By selecting option ‘View Graph:’ key, the graph appears on the screen, with all the details of X-axis and Y-axis. Select ‘PRINT’ option to obtain the print out.

Origin at : X =0.000 , y = 0.000

X / div = 2.500 , y / div = 0.150

3.000

+

PRINT

ESC

2.000

+

EDIT

+

1.000

+

+

0.001

+ +

0.000 10.00 20.00 40.00

Select ‘ACCEPT TEST’ option to save this test with the details of calibrator absorbance. It is possible to run the same test without loading calibrators. The previous graph can be used for new samples.

(* NOTE: If you do not want to run the calibrators each time, please select “ACCEPT TEST” option to save graph, whenever you run the test with calibrators.)

Version 150511 PI number: 1701327 Page 75 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

9.3.A. Invalid assay in Multi standard Mode

In Multi standard, the absorbance of calibrators should be in increasing or decreasing from one calibrator to the next calibrator. If any calibrator/s behave(s) incorrectly you will obtain a message

“Invalid Assay” at bottom side of screen.

Name: TSH

Pri: 450 Sec: 630

Range High > 16.61

MULTI STANDARD

BL Y CAL 7

Low < 10.30

ESC

NXT

HI CO : High >

LO CO : High >

Low < 0.000

Low < PREV

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050

B1 C1 0.070 0.070 0.000

SAVE

RESULT

C1 C2 0.257 0.257 2.500

---

---

---

Invalid Assay

LOAD PRINT PLATE

NXT MATRIX OPT.

VIEW

GRAPH:

ACCEPT PRINT

TEST RESULTS

If Assay is Invalid then “Accept Test”, “Save Results”, “Print Matrix”, “Save Plate” options are blocked. In such a case, select VIEW GRAPH option and change the ASSAY to VALID with the help of EDIT option present on the Graph screen.

CAL 1

CAL 2

CAL 3

CAL 4

CAL 5

CAL 6

CAL 7

2.562

1.865

2.050

1.054

0.648

0.356

0.045

ESC

CAL1 2.562

CAL 2 2.259

2.050 CAL 3

CAL 4 1.054

CAL 5

CAL 6

0.648

0.356

CAL 7 0.045

Numeric Value: 2.250

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Version 150511 PI number: 1701327 Page 76 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

You can easily select any particular calibrator by touching that touch zone and edit the corresponding absorbance . After editing the calibrator’s absorbance select “ESC”. A message will appear: “PLEASE WAIT…” and the modified graph will appear on the screen.

If calibrator's value being edited in Multistandard mode then "*Mod…" string is displayed in the print.

9.4. Kinetic:

Select “RUN” to start to run the test in Kinetic mode.

Name : KIN_560

Pri : 560 Sec : 0

Read Time : 1 min.

.

Read Period : 15 sec.

KINETIC

ESC

EDIT

RUN

PRINT

Or else you can directly run the test from the List Test screen by selecting RUN option present on the screen.

Select Test

1. HBSAg

ESC

2. HCVAb M RUN / SEL

3. UPT

4. TSH

5. CPC C

6. PER_ABS P NEXT

7. CRP C

8. KIN_560 K PREV

9. SIN_630 S

10. CP_405 C DEL

PLATE

DATA

Version 150511 PI number: 1701327 Page 77 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

The “D/M” means delta per minute of reaction. When test will over, instrument will show you the

“D/M” values of reaction done in each well.

Name: KIN_560

Pri : 560 Sec : 0

KINETIC

D/M D/M D/M D/M D/M D/M

1 2 3 4 5 6

D/M D/M

7 8

D/M

9

D/M D/M D/M

10 11 12

Is Plate Loaded ? YES / NO

Name: KIN_560

Pri : 560 Sec : 0

KINETIC

D/M D/M D/M D/M D/M D/M

1 2 3 4 5 6

D/M D/M D/M D/M D/M D/M

7 8 9 10 11 12

Is Plate Removed ? YES / NO

It is showing the “D/M” values for each and every well in table format.

Name: KIN_560 KINETIC

Pri : 560 Sec : 0

D/M D/M

1 2

D/M

3

D/M

4

D/M

5

D/M

6

0.020 0.002 0.010 0.035 0.056 0.001

0.030 0.056 0.075 0.100 0.068 0.090

-- --- --- --- --- ---

-- --- --- --- --- ---

D/M D/M

7 8

D/M

9

D/M

10

D/M

11

D/M

12

0.020 0.002 0.010 0.0.35 0.056 0.001

0.030 0.056 0.075 0.100 0.068 0.090

--- --- --- --- --- ---

ESC PRINTMATRIX SEND PLATE LOAD NEXT

Version 150511 PI number: 1701327 Page 78 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

In “PRINT MATRIX”, you will get the print of entire plate data with initial absorbance of each sample, average delta values of each sample and “D/M” values of each well, like…

A

W1 W2 W3 W4 W5 W6

0.200 0.100 1.200 0.300 2.600 0.900.. these are initial absorbance.

0.010 0.001 0.005 0.017 0.028 0.001.. these are average delta values.

0.020 0.002 0.010 0.035 0.056 0.001.. these are “D/M” values of each sample.

B

W1 W2 W3 W4 W5 W6

0.300 0.100 1.200 0.200 2.600 0.800..

0.015 0.028 0.037 0.050 0.034 0.045..

0.030 0.056 0.075 0.100 0.068 0.090..

On selecting “SEND PLATE” option user can send the plate data to computer with the help of USB or SERIAL communication.

“LOAD NEXT” is used to load the next plate.

Version 150511 PI number: 1701327 Page 79 of 117

U s s e r M a n u a l l

 Example Print-out obtained from ELISA READER

E L

I

I S A P L A T E R

E

A

D

E

R

(Note: Same Procedure can be used to create and run the test in all other modes, like

Single Standard, % Absorbance & Uptake)

Version 150511 PI number: 1701327 Page 80 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

10. RERUNNING ACCEPTED TESTS / PROGRAMS

“ACCEPT TEST” option is used to store the data of controls or calibrators. After running any test first time with controls or calibrators, you select option “Accept Test” to save the data of controls or calibrators, so that next time when you want to load the same test, there is no need to load controls or calibrators in ELISA plate. You can use previously stored data.

A) In “CUT OFF” Mode:

Name: HCV

Pri: 450 Sec: 560

No Factor QC

BL 1 Y

NC 3 1.000 Y

PC 2 0.100 Y

LC 0 1.000 N

CC 0 1.000 N

POS- Cut Off

0.100 0.050

0.150 0.098

0.500 2.658

CUTFAC: 0.200

QC1 2.560

CUTABS: 0.563

QC2

QC3 QC4

ESC

QCVal Mes. Rem ACCEPT

TEST

PRINT

Display

VALUE:

LOAD

NEXT

B) In “Multi standard” Mode:

Name: TSH

Pri: 450 Sec: 560

MULTI STANDARD

BL Y CAL 7

ESC

Range High > 16.61

HI CO : High >

LO CO : High >

Low < 10.30

Low < 0.000

NXT

Low < PREV

NO SAMP ABS AVG CONC REM PID

SAVE A1 B 0.050 0.050

B1 C1 0.070 0.070 0.000

C1 C2 0.257 0.257 2.500

---

RESULT

---

G1 S1 0.200 0.200 2.100 NEG TSH-1

H1 S2 1.854 1.854 9.845 POS TSH-2

LOAD PRINT PLATE

NXT MATRIX OPT.

VIEW

GRAPH

ACCEPT PRINT

TEST RESULTS

Version 150511 PI number: 1701327 Page 81 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

When you want to run such an accepted test, select ‘RUN’ option in test detail screen, in “CUT OFF” mode:

Name: HCV

Pri: 450 Sec: 560

POS- Cut Off

ESC

No. of Samples : 0

DUP N SIMUL

RUN

PID

1 2 3 4 5 6 7 8 9 10 11 12

Load Blank?

Name: HBSAG

YES / NO

Pri: 450 Sec: 630

No. of Samples : 0

DUP N SIMUL

POS- Cut Off

1 2 3 4 5 6 7 8 9 10 11 12

Load Controls? YES / NO

ESC

RUN

PID

This time, the blank and controls will not be loaded directly and you will get the following questions: “Load Blank? YES / NO” and “Load Controls? YES / NO”.

If you are running both, select ‘YES’, and if you want to use earlier stored data of controls select ‘NO’, so that you can run only samples to get their results without loading Blank and Controls.

If you want to load only ‘Blank’, select “Load Blank? YES” and

“Load Controls? NO”.

In case if you are using previously Stored “Blank” and “Controls” then it will print following strings in the printout-

“Using Blank Stored value…..” and “Using Controls Stored value….”

R

Version 150511 PI number: 1701327 Page 82 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

C) In Multi Standard / Single Standard / % Absorbance / Uptake Mode:

Name: TSH

Pri: 560 Sec: 0

No. of Samples: 0

MULTI STANDARD

ESC

RUN

DUP N SIMUL PID

1 2 3 4 5 6 7 8 9 10 11 12

Load Blank ? YES / NO

Name: TSH

Pri: 560 Sec: 0

MULTI STANDARD

No. of Samples: 0

ESC

RUN

DUP N SIMUL PID

1 2 3 4 5 6 7 8 9 10 11 12

Load Calibrators? YES / NO

In Calibrator Mode, after asking “Load Blank? Yes / No” you will get the following question “Load

Calibrators? Yes / No”. If you are loading new calibrators and want the results of samples as per new graph select “Load Calibrators? YES”.

Or else, If you are not loading new calibrators and want to use previously stored graph select “Load

Calibrators? No”.

If you want to load only ‘Blank’, select “Load Blank? YES” and “Load Calibrators? NO”.

In case if you are using previously Stored “Blank” and “Calibrators” then it will print following strings in the printout-

“Using Blank Stored value…..” and “Using Calibrator Stored value….”

Version 150511 PI number: 1701327 Page 83 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

NOTE: User can view the Saved Graph from the Test parameter screen before running the same test.

Name: TSH MULTISTANDARD

Pri: 560 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y EDIT

RUN

HI CO: Y High> 25.03 Low< 10.54 PRINT

LO CO: Y High> 16.61 Low< 5.45

Interpret’n: Y Range High> 15.25

Low< 9.46

Graph: 4 PARAMETER

Y vs X : ABS vs CONC

To change values press EDIT

On selecting GRAPH option, it will display following screen where user can select “PLOT” option

in order to view the Valid GRAPH Screen.

No Conc Abs No Conc Abs

1 0.000 0.220

2 10.00 0.454

3 25.00 0.725

4 50.00 1.026

5 100.00 1.269

6 150.00 1.850

7 200.00 2.000

ESC PRINT PLOT

Version 150511 PI number: 1701327 Page 84 of 117

U s s e r M a n u a l l

The Graph screen will be displayed as shown below-

Origin at : X =0.000 , y = 0.000

X / div = 2.500 , y / div = 0.150

3.000

+

2.000

+

1.000

+

+

+

ESC

PRINT

EDIT

0.001

0.000 10.00 20.00

+ +

40.00

11.SAMPLE AND SAMPLE DUPLICATE

E L

I

I S A P L A T E R

E

A

D

E

R

While loading the samples you can load a single sample in single well or a single sample in adjacent two well and finally the instrument will take the average of it as known as Sample

Duplicate.

The instrument will load the controls / calibrators automatically in any new test or not accepted test. You have to provide the number of samples. If you are loading single samples keep “DUP”-

No. Select “No. of Samples:” to enter total samples.

While loading the samples you can load a single sample in single well or a single sample in adjacent two well and finally the instrument will take the average of it known as Sample Duplicate.

The instrument will load the controls / calibrators automatically in any new test or not accepted test. You have to provide the number of samples. If you are loading single samples keep “DUP”-

No. Select “No. of Samples:” to enter total samples.

Version 150511

Name: HCV POS- Cut Off

Pri: 450 Sec: 560

DUP N

ESC

Page 85 of 117

SIMUL PID

1 2 3 4 5 6 7 8 9 10 11 12

B

NC

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

B

NC

NC

NC

PC

PC

Name: HCV

Pri: 450 Sec: 560

POS- Cut Off

ESC

No. of Samples: 0 RUN

DUP N SIMUL PID

1 2 3 4 5 6 7 8 9 10 11

12

Name: HCV

Pri: 450 Sec: 560

No. of Samples : 10

POS- Cut Off

ESC

RUN

DUP N SIMUL PID

1 2 3 4 5 6 7 8 9 10 11 12

B S3

NC S4

NC S5

NC S6

PC S7

PC S8

S1 S9

S2 S10

If you want to load duplicate samples select “DUP” option and then enter the number of samples by selecting “No. of Samples”

Name: HCV

Pri: 450 Sec: 560

POS- Cut Off

No. of Samples : 0

DUP Y SIMUL PID

ESC

RUN

1 2 3 4 5 6 7 8 9 10 11 12

B

NC

NC

NC

PC

PC

Name: HCV

Pri: 450 Sec: 560

No. of Samples : 0

DUP Y SIMUL

POS- Cut Off

PID

ESC

RUN

1 2 3 4 5 6 7 8 9 10 11 12

B

NC

NC

NC

PC

PC

Numeric Value: 10

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Version 150511 PI number: 1701327 Page 86 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Name: HCV

Pri: 450 Sec: 560

POS- Cut Off

ESC

No. of Samples : 10

DUP Y SIMUL PID

RUN

1 2 3 4 5 6 7 8 9 10 11 12

B S2 S6 S10

NC S2 S6 S10

NC S3 S7

NC S3 S7

PC S4 S8

PC S4 S8

S1 S5 S9

S1 S5 S9

(* Similarly, user can load the samples and Sample Duplicates in all other modes)

12.PATIENT IDENTITY / SAMPLE IDENTITY ENTRY

A.) To enter a patient ID for all samples there is option provided in loading screen shown

as “PID”.

After entering number of samples either single or duplicate, select “PID”.

Version 150511 PI number: 1701327 Page 87 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

A) Individual PID entry -

Name: HCV

Pri: 450 Sec: 560

No. of Samples: 10

DUP N SIMUL

POS- Cut Off

PID

ESC

RUN

1 2 3 4 5 6 7 8 9 10 11 12

B S3

NC S4

NC S5

NC S6

PC S7

PC S8

S1 S9

S2 S10

Sample

1

PID

PRST123

ESC

2

3

4

5

6

7

8

NEXT

9 PREV

10 SEQL

Sample PID

1 PRST123

ESC

2

3

4

5

6

7

8

NEXT

9 PREV

10 SEQL

PRST123

A B C D E F G H

I J K L M N O P ENTER

Q R S T U V W X CLEAR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

One by one you can enter name of each patient. The character length of PID is only 7 characters in the following combinations –

Since PID of the Patient is entered with the help of Alpha-numeric characters, the combination must be as mentioned below.

Alphabets

4

3

2

Numbers

3

4

5

For example -

1. In the first combination, user can enter PID with 4 Alphabets and 3 Numbers. That means, entered PID should be PQRS123

2. Similarly, for the second combination, user can enter PID with 3 Alphabets and 4 Numbers.

And therefore, entered PID will be UTV1234

3. And for the third combination, user can enter PID with 2 Alphabets and 5 Numbers ie. PID will be displayed as RB12345

Version 150511 PI number: 1701327 Page 88 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

4. But one can’t enter the PID with 1 Alphabet and 6 Numbers since its maximum numeric count is 65500.

(Note: The same combinations should be used during SEQUENTIAL entry also.)

B) Sequential Patient ID Entry

This one by one entry will take more time, therefore one more option to enter Patient Ids is provided. This option is “SEQL” sequential entry.

If you select “PID” option for patient ID entry, the following question appears on the screen:

“Delete Previous PIDs? Yes / No”.

If you select NO, it will directly load the previously entered

PIDs for sample and if you select YES, it will delete the previous PIDs.

Now select ‘SEQL’, it will display Alphanumeric screen where user can enter different sequential

PIDs. Follow the steps below-

Enter Alphabets

PRST

A B C D E F G H

I J K L M N O P ENTER

Q R S T U V W X CLEAR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

Enter Initial Sample number

Numeric Value: 01

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR well location of any particular batch.

S

S

Enter last sample number

Numeric Value: 10

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Enter Initial PID Number. This is the starting

Enter initial PID number

Numeric Value: 123

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Enter last Well Number. This is the last well

Version 150511 PI number: 1701327 Page 89 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

The final screen will appear which displays the sequential IDs of patient samples for the well location that is selected.

Sample

1

2

3

4

5

6

7

8

9

10

PID

PRST123

ESC

PRST124

PRST125

PRST126

PRST127

PRST128 NEXT

PRST129

PRST130 PREV

PRST131

PRST132 SEQL

Go to the next and previous screen with the help of “NEXT” and “PREV” option present on the screen.

(*NOTE: The entered PID get stored in instrument memory, until you delete it by using option,

“Delete previous PIDs? Yes / NO”)

13.SAVE PLATE AND SAVE RESULTS

In all modes of operation, there are two options provided to store results.

A) In cut Off mode:

Name: HCV POS- Cut Off

Pri: 450 Sec: 560 BL Y

Range PERCENTAGE % 10.00

ESC

NXT

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050

B1 NC

--

--

--

--

--

--

PRINT

RESULTS

SAVE

RESULTS

PRINT

MATRIX

PLATE

OPT.

PREV

Version 150511 PI number: 1701327 Page 90 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

B) In Multi standard or any calibrator mode:

Name: TSH

Pri: 450 Sec: 0

Range High > 16.61

HI CO : High >

LO CO : High >

MULTI STANDARD

BL Y CAL 7

Low < 10.30

Low <

Low <

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050

B1 C1 0.070 0.070 0.000

C1 C2 0.257 0.257 2.500

--

--

--

--

LOAD PRINT PLATE

NXT MATRIX OPT.

VIEW

GRAPH:

ACCEPT

TEST

ESC

NXT

PREV

SAVE

RESULT

PRINT

RESULTS

If “PLATE OPT.”is selected , you will obtain two options.

1. SAVE PLATE DATA ESC

2. SEND PLATE DATA

1. “SAVE PLATE DATA”, it helps the user to save the entire plate information along with the control/calibrator information (maximum 10 plates data can be saved).

2. “SEND PLATE DATA” is used to send the data from instrument to computer through USB or serial RS232 connection.

If “SAVE RESULT” option is selected the information of samples only except controls/calibrators, with test name, patient ID and date will be saved.

Version 150511 PI number: 1701327 Page 91 of 117

U s s e r M a n u a l l

14.VIEW STORED DATA

E L

I

I S A P L A T E R

E

A

D

E

R

The stored plate or stored results appear on the screen by selecting option “View Plate” in “MAIN

MENU”.

MAIN MENU

1 Test Operations ESC

1 PLATE RESULTS ESC

2 Technical Diagnosis

2 PATIENT RESULTS

3 Utilities

4 View Plate

5 Serial Communication

14.1. PLATE RESULT:

It displays the details of stored plate (last 10 plates) with date, test name and

mode of operation in descending order. User can select any test to view its plate

results by selecting this option.

1. PLATE RESULTS

2 PATIENT RESULTS

ESC

SIN_405 02/01/12

NO SAMP ABS AVG RES REM PID

A1 C1 0.083 0.083 50.00

B1 S1 0.544 0.544 326.7 POS VSP-1

C1 S2 0.367 0.367 220.3 NEG VSP-2

D1 S3 0.538 0.538 322.9 POS VSP-3

NO DATE TEST MODE ESC

4 02/01/12 SIN_405 S

3 01/01/12 TSH M SEL

E1 S4 0.300 0.300 180.2 NEG VSP-4

F1 S5 0.700 0.700 420.0 POS VSP-5

2 30/12/11 HBSAG C

1 28/12/11 CPC C

4 02/01/12 SIN_405 S

Press Select key ot proceed

-- -- --- --- ---- --- ---

-- -- --- --- ---- --- ---

G2 S14 0.326 0.326 195.6 NEG VSP-14

H2 S15 0.491 0.491 294.7 EQ VSP-15

ESC NEXT PREV PRINTMATRIX SENDDATA PRINT

“Print Matrix” will print the details of entire plate in matrix format as explained earlier.

“Print” will print only the data displayed on screen.

“Send data” can be used to send the data from instrument to computer through USB or serial

RS232 connection.

Version 150511 PI number: 1701327 Page 92 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Note: User can directly view the details of Plate Results by accessing it through Plate Data option present on the Select Test screen.

Select Test ESC

1. HBSAg

2. HCVAb M RUN / SEL

3. UPT

4. TSH

5. CPC C

6. PER_ABS P NEXT

7. CRP C

8. KIN_405 K PREV

9. SIN_630 S

10. CP_560 C DEL

PLATE

DATA

14.3. PATIENT RESULTS

It will show the details of all samples, saved in memory using option “SAVE RESULTS”

in all different modes, as explain earlier. This option will display the data in table format

as shown below. Test name, Mode of test operation, result of sample, PID and Remark will

appear on the screen. The instrument has a memory to store 2500 sample results.

This option doesn’t show the information of controls or calibrators.

01 / 01 / 08

Test M Result PID Remarks

1 PLATE RESULTS ESC

2 PATIENT RESULTS

MUL_4P M 10.48 VSR1 EQ

MUL_4P M 12.63 VSR2 POS

MUL_4P M 7.450 VSR3 NEG

MUL_4P M 13.80 VSR4 POS

SIN405 S 267.7 NRA1 EQ

SIN405 S 220.3 NRA2 NEG

SIN405 S 180.2 NRA3 NEG

SIN405 S 326.7 NRA4 POS

ESC NEXT PREV PRINT

“PRINT” is used to print the details as available on the screen.

“NEXT” and “PREV” options are used to browse through the pages so that one can view

all the results one after the other.

NOTE:

1. When there is not enough memory the following message appears:

“Memory Left for samples- First Samples Deleted”

The instrument automatically deletes a number of samples that are stored in the beginning

Version 150511 PI number: 1701327 Page 93 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

and then save the new samples at that location.

2. If a test is being deleted or edited then previously stored results of that particular test are displayed with their test mode as "X". But test name retained as it is.

01 / 01 / 08

Test M Result PID Remarks

MUL_4P X 10.48 VSR1 EQ

MUL_4P X 12.63 VSR2 POS

MUL_4P X 7.450 VSR3 NEG

MUL_4P X 13.80 VSR4 POS

SIN405 S 267.7 NRA1 EQ

SIN405 S 220.3 NRA2 NEG

SIN405 S 180.2 NRA3 NEG

SIN405 S 326.7 NRA4 POS

ESC NEXT PREV PRINT

15. UTILITIES

UTILITIES consists of 11 different functions which can be viewed as follows-

MAIN MENU

1 Test Operations

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

ESC

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

Version 150511 PI number: 1701327 Page 94 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

15.1. Date & Time Setting

This Utility helps the user to set current Date and Time.

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

Date – DD / MM / YY

01 / 01 / 08

Time – Hrs : Min : Sec

12 : 30 : 10

15.2. Program Filter

It consists of two editable filters and thus helps the user to edit the filters if any.

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

Edit Filters? YES / NO

XXX

Numeric Value : 250

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

XXX 250

YYY

Numeric Value : 400

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

ESC

Version 150511 PI number: 1701327 Page 95 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

15.3. Printer On / Off setting:

Its a toggle between Printer ON and Printer OFF

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

15.4. Enter Clinic Name:

Type your Clinic Name and select “ENTER”. The character length is maximum 19 characters.

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

UTILITIES Version (3.400A)

CLINIC

TATA_MEMORIAL

A B C D E F G H

I J K L M N O P ENTER

Q R S T U V W X CLR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

Version 150511 PI number: 1701327 Page 96 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

15.5. Shaker (Plate Shaking Mode)

Shaker is used for shaking the plate before running any test. The Shaker screen is displayed as follows -

ESC Shake Time 0 sec

Shake Speed 0

Start

Stop

Shake Time 0 sec

Shake Speed 0

Start

ESC

Stop

Numeric Value: 20

1 2 3 4 5 6 ENTR

7 8 9 0 . CLR

Shake Time 20 sec

Shake Speed 0

Start

Stop

Numeric Value: 05

1 2 3 4 5 6 ENTR

7 8 9 0 . CLR

ESC

The total shake time can be entered in seconds

Regarding the “Shake Speed”, there are 10 types of speeds. You can choose any speed by entering numbers from 1 to 10. The shaking speed increases as the number increases.

After entering shake time and shake speed, select Start option. When “Start” is selected, the tray will come out and on the screen you will obtain a message “Is plate loaded? Yes / No”. Load the plate and select YES option.

Shake Time 20 sec

Shake Speed 5

Start

Stop

ESC

Shake Time 20 sec

Shake Speed 5

Start

Stop

Is Plate Loaded? Yes / NO

ESC

After selecting ‘YES’ the tray will go inside and instrument will do the shaking of plate for the given time period with selected speed.

Version 150511 PI number: 1701327 Page 97 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

When the shaking is finished, the plate holder will come out and display a message-

“Is plate removed? Yes / No”. Remove the plate and select ‘YES’ to end the process.

Shake Time 20 sec

Shake Speed 5

Start

Stop

ESC

Is Plate Removed ? Yes / NO

Similarly, to stop the Shaking process in between select “STOP” option present on the screen.

After selecting STOP option it will display the message string – ‘Is Plate Removed? YES / NO’.

Select NO to terminate the ongoing process.

Note: ‘HOME’ key is also used for directly accessing the shaking mode (ie. SHAKER)

15.6. Communication Settings:

It is a toggle between USB and SERIAL communication. User can either switch to USB or Serial communication by connecting their respective cables.

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : SERIAL

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

This setting is very important, whenever you want to transfer data from instrument to computer.

You can transfer data either using USB or by Serial RS232 cable.

Version 150511 PI number: 1701327 Page 98 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

15.8. Install USB Driver:

This option present in the Utilities helps the user to install the USB Drivers in their respective computers. Remember that before installing the USB drivers you must first switch on to the

USB communication settings.

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

Install USB Drivers ? YES / NO

15.9. Auto Print: ON

It is a toggle key between Auto Print: ON and Auto Print: OFF.

After completing the running process it automatically takes the print of the result and its

graph if any in order to maintain the record of the plate run in the form of hard copy.

Auto Print is active in all modes excluding ABS mode. For Auto Print, user must set the printer ON otherwise it will display the error string “Disable printer YES / NO?”

NOTE: The option 8. “CV Diagnostic OFF” is not for users. It is for factory use only.

Version 150511 PI number: 1701327 Page 99 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

15.10. PASSWORD:

Select Password option in order to Set the Password so that one can’t ADD, EDIT,

DELETE and SEND / RECEIVE Test records without entering the valid Password.

UTILITIES Version (3.400A)

1 Date and Time ESC

2 Program Filter

3 Printer On / Off: ON

4 Enter Clinic Name

5 Shaker

6 Communication Settings : USB

7 CV Diagnostic OFF

8 Install USB Driver

9 Auto Print: OFF

10 Password

Password Utility

1 Enable / Disable ESC

2 Set Password

3 LOGIN

4 LOGOUT

15.10.1. ENABLE / DISABLE:

Enable / Disable helps the user to set the Password or Remove the Password from the

Password Utility. Enter Password with the help Alphanumeric screen which is displayed after selecting Enable / Disable option.

Version 150511 PI number: 1701327 Page 100 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Password Utility

1 Enable / Disable ESC

2 Set Password

3 LOGIN

4 LOGOUT

ESC

ADMIN PASSWORD

A B C D E F G H

I J K L M N O P ENTER

Q R S T U V W X CLR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

15.10.2. SET PASSWORD:

This option helps to set the PASSWORD along with the USER name.

Password Utility

1 Enable / Disable ESC

2 Set Password

3 LOGIN

4 LOGOUT

USER TANIYA

A B C D E F G H

ADMIN PASSWORD

A B C D E F G H

I J K L M N O P ENTER

Q R S T U V W X CLR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

Enter “PASSWORD” and select ENTER

I J K L M N O P ENTER

Q R S T U V W X CLR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

Enter appropriate USER name and select ENTER

Version 150511 PI number: 1701327 Page 101 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

15.10.3. LOGIN:

After entering the Password user needs to select LOGIN.

Password Utility

1 Enable / Disable ESC

2 Set Password

3 LOGIN

4 LOGOUT

USER TANIYA

A B C D E F G H

I J K L M N O P ENTER

Q R S T U V W X CLR

Y Z , - + _ 1 2

3 4 5 6 7 8 9 0

To Login/ enable user, enter the USER name and select ENTER

15.10.4. LOGOUT:

Password Utility

1 Enable / Disable ESC

2 Set Password

3 LOGIN

4 LOGOUT

Password Utility

1 Enable / Disable ESC

2 Set Password

3 LOGIN

4 LOGOUT

Logout

To Logout / disable user, select LOGOUT option

present on the screen

Version 150511 PI number: 1701327 Page 102 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

16. SERIAL COMMUNICATION

The instrument is equipped with an RS232 serial port for PC configuration ie. User-computer interface. A cable (a NULL-MODEM cable) is required (not provided) to link the instrument to PC.

Communication will only start when both ends detect the presence of an active terminal or device.

RS232 port settings in a windows Operating system.

PORT SETTINGS

Bits per second : 9600

Data Bits : 8

Parity None : None

Stop Bits : 1

Flow control : None

There is an option present on the Main menu screen named as SERIAL Communication which is used for transferring data from instrument to the computer and also from instrument to instrument.

MAIN MENU ESC

1. Test Operations

2. Technical Diagnosis

3. Utilities

4. View Plate

5. Serial communications

Version 150511 PI number: 1701327 Page 103 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

16.1. Send Results:

SEND RESULTS helps the user to transfer all the Results stored in the instrument to the computer via Serial Communication.

Results can be send either through USB or SERIAL communication.

Before Sending the Results :

- A driver and the corresponding Data Transfer application must be downloaded on your computer.

Further information can be requested to our distributor or to our technical support Department,

[email protected]

-check whether the Serial cable / USB cable is connected to both the ends of the instrument and the computer respectively.

MAIN MENU

1. Test Operations ESC

2. Technical Diagnosis

SERIAL COMM.

ESC

1 Send Results

2 Send Test Records

3 Receive Test Records

3. Utilities

4. View Plate

5. Serial communications

SERIAL COMM. ESC

1 Send Results

2 Send Test Records

3 Receive Test Records

Sending…..

SERIAL COMM. ESC

1 Send Results

2 Send Test Records

3 Receive Test Records

Send Results? YES / NO

Version 150511 PI number: 1701327 Page 104 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

These Results are send through Application, and the Excel file is created as shown below –

Version 150511 PI number: 1701327 Page 105 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

16.2. Send Test Records:

This option helps the user to send the Test Records created in one instrument to another instrument serially with the help of serial cable. And therefore one has to select serial communication in Utilities.

SERIAL COMM.

ESC

1 Send Results

2 Send Test Records

3 Receive Test Records

SERIAL COMM.

ESC

1 Send Results

2 Send Test Records

3 Receive Test Records

Send Test Records? YES / NO

Suppose by default if Serial Communication is set to USB then it will display following screen with msg string.

SERIAL COMM.

1 Send Results

2 Send Test Records

3 Receive Test Records

Invalid in USB communication !!!

ESC

Version 150511 PI number: 1701327 Page 106 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

16.3. Receive Test Records:

This option is used for receiving the Test Records from one instrument to another. On selecting “Receive Test Records”; it will display the string – Download Test Records? Yes /

No. Select “Yes” in order to receive the data from the other instrument.

ESC

1 Send Results

2 Send Test Records

3 Receive Test Records

SERIAL COMM. SERIAL COMM.

ESC

1 Send Results

2 Send Test Records

3 Receive Test Records

Download Test Records ? YES / NO

Note: 1. User must first restart the instrument before sending the data from one instrument to

another.

2. Remember that while transferring Test Records from one instrument to another

one must first select “Receive Test Records” and then select

“Send Test Records” in order to send the data from one instrument to another.

For instance, let us take an example which will show how the Test Records are

transferred from instrument to instrument.

Let “Instrument 1” resemble the screen of the Instrument which will receive the Test

Records from other instrument. And “Instrument 2” resemble the screen of the

Instrument which will send the Test Records to other instrument.

Instrument 1

MAIN MENU ESC

SERIAL COMM.

1. Test Operations

1 Send Results

ESC

2. Technical Diagnosis

3. Utilities

4. View Plate

5. Serial communications

2 Send Test Records

3 Receive Test Records

Download Test Records ? YES / NO

Version 150511 PI number: 1701327 Page 107 of 117

U s s e r M a n u a l l

Now for Sending Test Records switch on to Instrument 2.

Instrument 2

E L

I

I S A P L A T E R

E

A

D

E

R

MAIN MENU ESC

1. Test Operations

2. Technical Diagnosis

3. Utilities

4. View Plate

5. Serial communications

SERIAL COMM.

1 Send Results

2 Send Test Records

3 Receive Test Records

ESC

Send Test Records? YES / NO

Select “YES” in order to send all the test records

SERIAL COMM.

1 Send Results

2 Send Test Records

3 Receive Test Records

Sending……..

ESC

And similarly, Instrument 1 will display the following screen which denotes that the instrument is downloading the Test Records.

SERIAL COMM.

1 Send Results

2 Send Test Records

3 Receive Test Records

1248

ESC

After completing the process of transferring the data, one must restart both the instrument and check for the data transferred between the instruments

In this way, one can transfer Test Records from instrument to instrument.

Version 150511 PI number: 1701327 Page 108 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

3. User can Send and Receive the Test Records only through serial cable and

therefore one has to set the Serial Communication: SERIAL in Utilities.

If Serial Communication is set to USB, then it will display following screen –

SERIAL COMM.

1 Send Results

2 Send Test Records

3 Receive Test Records

Invalid in USB communication !!!

ESC

17. TECHNICAL DIAGNOSIS

Technical Diagnosis is present in “Main Menu”.

MAIN MENU

1 Test Operations

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

ESC

TECHNICAL DIAGNOSIS

1. Clear Memory

2. Lamp Amplitude

3. Printer Self test

4. Lamp Centering Check

ESC

17.1. Clear Memory

This option is used to clear entire saved test records and entire saved patient results along with saved plates. The “Test Records” are the different kind of programmed test that are made in different modes of operation and saved in instrument program memory.

TECHNICAL DIAGNOSIS ESC

1. Clear Memory

2. Lamp Amplitude

3. Printer Selftest

Clear Results? YES / NO

Version 150511 PI number: 1701327

TECHNICAL DIAGNOSIS

1. Clear Memory

2. Lamp Amplitude

3. Printer Selftest

ESC

Clear Test Records? YES / NO

Page 109 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

When option “Clear Memory” is selected the instrument will first ask “Clear Results YES / NO”.

If “YES”is selected it will only clear saved patient results and saved plates stored in the memory, and shows message “Clearing Memory …”.

This option does not clear the programmed test saved in instrument memory.

After clearing the memory or if option “NO” is selected the next question appears.

17.2. Lamp Amplitude

This option is used to check the light gain of filters used in the instrument. There are 8- channels used of same type. This option shows the gain of each channel filter in table format. In the instrument the range of amplitude is from 600.00 to 2450.00. If the amplitude goes below 600.00 for any channel, the message “Amp –Low” will appear on the screen for that particular channel if the amplitude goes more than 2490.00, than the over range saturation voltage figure of 2500.00 will be passed.

The gains of filters are set within a required range. When you select this option, the lamps will turn

ON, tray holder plate will comes out and the instrument will start showing amplitudes (gains) of all filters one by one.

TECHNICAL DIAGNOSIS

1. Clear Memory

2. Lamp Amplitude

3. Printer Self test

4. Lamp Centering Check

ESC

LAMP AMPLITUDE

1 Stability Check

2 Filter Amplitude

ESC

Version 150511 PI number: 1701327 Page 110 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

1. Stability Check:

LAMP AMPLITUDE

1 Stability Check

2 Filter Amplitude

ESC

LAMP AMPLITUDE

1 Stability Check

2 Filter Amplitude

ESC

Displays the Lamp amplitude of a single selected filter.

Filter : 405 ESC

CH1 CH2 CH3 CH4

1921.8 2011.7 1983.7 1875.2

1920.4 2010.3 1982.4 1874.2

1919.4 2009.3 1981.7 1873.4

1918.5 2008.5 1981.2 1872.9

1918.0 2007.8 1980.8 1872.5

--- ---- --- ----

--- ---- --- ----

--- ---- ---- ---

CH5 CH6 CH7 CH8

1921.0 1868.4 1899.1 1848.0

1919.9 1867.3 1898.1 1846.6

1919.2 1866.5 1897.4 1845.8

1918.7 1866.0 1896.9 1844.9

---- ---- ---- ----

--- ---- ---- ----

LAMP AMPLITUDE

1 Stability Check

2 Filter Amplitude

Select Filter Val:

0 405 450

492 630 NA

NA 560 YYY

ESC

Filter : 560 ESC

CH1 CH2 CH3 CH4

1997.6 1869.1 2042.2 2014.2

1997.5 1868.9 2042.3 2014.3

1997.2 1868.9 2042.3 2014.5

1997.1 1868.9 2042.5 2014.6

1997.0 1868.7 2042.6 2014.7

--- ---- --- ----

--- ---- --- ----

--- ---- ---- ---

CH5 CH6 CH7 CH8

1904.8 2007.7 1891.1 1935.2

1904.7 2007.7 1891.1 1934.9

1904.9 2007.7 1891.2 1935.0

1905.1 2007.9 1891.3 1934.9

---- ---- ---- ----

--- ---- ---- ----

Version 150511 PI number: 1701327 Page 111 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

17.3. Printer Self test

It is used to check the printing of thermal printer. Is it printing perfectly or not?

When you select this, it will print first two lines of Technical Diagnosis Screen.

17.4. Lamp Centering Check:

NOTE: “Lamp Centering Check” is not for users. Do not select this option and

don’t change any settings otherwise the mechanical alignment will get

disturbed, since it is for factory use only.

Version 150511 PI number: 1701327 Page 112 of 117

U s s e r M a n u a l l

18. Trouble Shooting

E L

I

I S A P L A T E R

E

A

D

E

R

1) Printer disabled

Disable Printer YES / NO?

2) “Check Light Path!!! CH x”

Where ‘x’ is any channel number

X = 1/2/3/4/5/6/7/8

CAUSE /CORRECTIVE ACTION

You will get this message, if paper is not loaded properly or lever is not at correct position. Check all possibilities.

Also check ON LINE and FEED LED glowing or not and when you switch ‘ON’ the instrument check paper is moving forward or not. If LEDs are not glowing and paper is not moving forward contact service engineer.

You can get this message in any mode of operation. Before reading absorbance, instrument is checking the filter reference voltages of all 8 channels. If filter voltage of any channel is less than minimum required voltage, it will display a message “Check Light Path!!! CH x”. Here ‘x’ is channel numbers having reference voltage less than minimum required.

For ex. If reference voltage of channel 3 is less the message will be displayed “Check Light Path!!! CH 3”. It will indicate all channel numbers having less reference voltage, like

“Check Light Path!!! CH 1 3 6 ”

In such a case, there is a possibility of filter gain of that channel is reduced or intensity of lamp of that channel has become poor, so contact factory engineer.

3) Invalid Assay

If in the Cut Off and Multi standard mode the controls and standards are not ok then this error message will appear.

4) Memory Full

If Number of saved tests exceeds the memory limit of 250 tests then delete the unwanted tests and save the test.

Version 150511 PI number: 1701327 Page 113 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

Using data receiving application on computer,

1) If you have not connected the data cable (USB or Serial) correctly, you will get this message.

2) If you have selected ‘Communication Setting’ (ref.

14.5), USB on instrument, and you have selected a ‘Serial’

5) “Check USB Application on communication on computer data receiving application,

Computer you will get this message. In such a case select ‘USB’

Do you want to continue? communication, on computer and select ‘YES’ key to

YES / NO” transfer data.

To avoid this message, connect proper data cable, select the same communication medium (USB or Serial), on computer data receiving application, which you have selected on instrument ‘Communication Setting’.

6) Filter Movement Error!!!

7) Plate Movement Error!!!

Instrument will display this message, if there is problem with MOC sensor PCB or with filter tray stepper motor.

The MOC sensors are used to detect the position of filter tray. These two sensors are mounted on bottom of the mechanism. One detects the home position and second detects the each filter position of filter tray. In such a condition we need to check the connection to these sensor and also the connection of stepper motor, which is used to move filter tray.

Instrument will display this message, if there is problem with MOC sensor PCB or with plate carrier stepper motor.

The MOC sensors are used to detect the position of plate carrier. These two sensors are mounted on top of the mechanism. One detects the home position and second detects the each strip position of plate carrier. In such a condition we need to check the connection to these sensor and also the connection of stepper motor, which is used to move plate carrier.

Version 150511 PI number: 1701327 Page 114 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

19. DECONTAMINATION

19.1. Decontamination Procedure

If the instrument is to be shipped after being exposed to potentially hazardous material, it should be decontaminated. The following procedure outlines the method of decontaminating the instrument before packaging and shipment.

19.2. Purpose of Decontamination

Decontamination minimizes the risk to all who come in contact with the instrument during shipping, handling, and servicing.

19.3. General Considerations

Any laboratory instrument that has been used for clinical analysis is considered a biohazard and should be decontaminated prior to handling. Intact skin is generally considered an effective barrier against infectious Organisms; however, small abrasions and cuts may not be always being visible. Prophylactic gloves must be worn when handling instruments that have not been decontaminated. Gloved hands should be considered contaminated at all times and must be kept away from eyes, mouth and nose at all times.

 Mucous membranes are considered prime entry routes for infectious agents. Wear eye protection and a surgical mask when there is a possibility of aerosols.

 Eating and drinking while decontaminating instruments is not advisable.

19.4. Procedure

 A solution of .5% Sodium Hypo Chlorite (NaOCL) solution (Bleach) is used.

Commercial bleach is 5% NaOCL; household bleach is 3% NaOCL. When using commercial bleach, use a 10:1 mixture; if using household bleach, a 6:1 mixture is required. This is a caustic solution. It is important to wear gloves and eye protection when handling it.

 Wipe down the carrier and all exposed surfaces of the unit with the bleach solution.

Remove the top shroud of the instrument and wipe down the top surface of the instrument base, as well as the inside of the top shroud.

 Rinse all the decontaminated carrier and exposed surfaces will distilled water.

 Reassemble the unit and discard the used gloves and towels.

Version 150511 PI number: 1701327 Page 115 of 117

U s s e r M a n u a l l

E L

I

I S A P L A T E R

E

A

D

E

R

20. SAFETY CLEARANCE CERTIFICATE

Please complete all information requests on this form prior to returning the instrument to the manufacturer or your local distributor for servicing, repairs or return. Thank you for your co-operation.

Customer Contact

Address

Dept

Tel:

Position

Country

Post Code

Model No.

Accessories

Returned

Fax:

Serial No.

Date of Purchase (if known)

Complaint

Has the equipment been exposed to any of the following: (*delete as applicable) a) Blood, body fluids, pathological specimens *YES/NO

If YES, please specify

Version 150511 PI number: 1701327 Page 116 of 117

U s s e r M a n u a l l b) Other Biohazard

If YES, Please specify

E L

I

I S A P L A T E R

E

A

D

E

R

*YES/NO

Version 150511 PI number: 1701327 Page 117 of 117

advertisement

Was this manual useful for you? Yes No
Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Download PDF

advertisement