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Human amylin elisa

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User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 1 of 113

ELISA Plate Analyzer

A.D. TOUCH

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 2 of 113

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

2.1. USE OF THE INSTRUMENT .......................................................................................................... 7

3. INTRODUCTION ..................................................................................................................... 8

3.1. DESCRIPTION ............................................................................................................................. 8

3.2. SPECIAL FEATURES ................................................................................................................. 8-9

3.3. TECHNICAL SPECIFICATION OF A. D. TOUCH ................................................................... 10-11

4. PACKAGING, TRANSPORT AND STORAGE .................................................................. 12

4.1. GENERAL WARNINGS .............................................................................................................. 12

4.2. PACKAGING ............................................................................................................................. 12

4.3. INSTRUMENT TRANSPORTATION .............................................................................................. 12

4.4. STORAGE OF INSTRUMENT ....................................................................................................... 12

5. INSTRUMENT DESCRIPTION ........................................................................................... 13

5.1. INSTRUMENT WORKING PRINCIPLE ......................................................................................... 13

5.2. PERSPECTIVE VIEW .................................................................................................................. 14

5.3. REAR VIEW ............................................................................................................................. 15

5.4. KEYPAD .................................................................................................................................. 16

6. INSTALLATION PROCEDURE AND VERIFICATION CRITERIA………………….17

6.1. UNPACKING INSTRUCTIONS ..................................................................................................... 17

6.2. PLACING THE INSTRUMENT...................................................................................................... 17

6.3. POWER SUPPLY REQUIREMENTS .............................................................................................. 17

6.4. PROTECTIVE GROUNDING ........................................................................................................ 17

6.5. PRINTER ............................................................................................................................. 18-19

6.6. START UP INSTRUCTIONS ......................................................................................................... 20

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01.09.2009/ Version 00 Page 3 of 113

6.7. TOUCH PANEL CHECK ............................................................................................................. 21

6.8. MICRO TITER PLATE CARRIAGE .............................................................................................. 22

6.9. PLATE LOADING & PIPETTING PROCEDURE ............................................................................. 23

6.10. READINGS CHECK ................................................................................................................. 24

7. PRECAUTIONS ...................................................................................................................... 24

8. PROGRAMMING MODES ................................................................................................... 25

8.1. ABSORBANCE MODE .......................................................................................................... 25-28

8.2. SINGLE STANDARD .................................................................................................................. 29

8.3. CUT OFF MODE .................................................................................................................. 30-47

8.4. REVERSE CUT OFF MODE ........................................................................................................ 48

8.5. MULTI STANDARD MODE ................................................................................................... 48-64

8.6. PERCENTAGE ABSORBANCE .................................................................................................... 65

8.7. UPTAKE .................................................................................................................................. 65

8.8. KINETIC MODE OF OPERATION ............................................................................................ 66-68

9. RECALLING AND RUNNING OF STORED TEST/PROGRAMS................................... 69

9.1. ABSORBANCE MODE .......................................................................................................... 70-72

9.2. CUT OFF MODE ................................................................................................................... 73-77

9.2. A. Invalid Assay in Cut Off Mode ...................................................................................... 78-79

9.3. MULTI STANDARD MODE ................................................................................................... 80-85

9.3.A. Invalid assay in Multi standard Mode ........................................................................... 86-87

10. RERUNNING ACCEPTED TESTS / PROGRAMS ..................................................... 88-89

11. SAMPLE AND SAMPLE DUPLICATE ........................................................................ 90-93

12. PATIENT IDENTITY / SAMPLE IDENTITY ENTRY ............................................... 95-97

13. SAVE PLATE AND SAVE RESULTS ................................................................................ 99

14. VIEW STORED DATA ............................................................................................... 100-101

15. UTILITIES .......................................................................................................................... 102

15.1. DATE AND TIME SETTING .................................................................................................... 102

15.2. PRINTER ON / OFF SETTING ................................................................................................. 103

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01.09.2009/ Version 00 Page 4 of 113

15.3. CLINIC NAME ENTRY. ......................................................................................................... 103

15.4. PLATE SHAKING MODE (SHAKER) ....................................................................................... 104

15.5. COMMUNICATION SETTINGS ................................................................................................ 105

16. SERIAL COMMUNICATION .......................................................................................... 106

17. TECHNICAL DIAGNOSIS ............................................................................................... 107

17.1. CLEAR MEMORY ................................................................................................................. 107

17.2. LAMP AMPLITUDE ............................................................................................................... 108

17.3. PRINTER SELF TEST ............................................................................................................. 109

18. TROUBLE SHOOTING.............................................................................................. 110-111

19. DECONTAMINATION ..................................................................................................... 112

19.1. DECONTAMINATION PROCEDURE ........................................................................................ 112

19.2. PURPOSE OF DECONTAMINATION ........................................................................................ 112

19.3. GENERAL CONSIDERATIONS ................................................................................................ 112

19.4. PROCEDURE ......................................................................................................................... 112

20. SAFETY CLEARANCE CERTIFICATE ....................................................................... 113

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01.09.2009/ Version 00 Page 5 of 113

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.

apDia 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.

In case of tenders warranty would be as per tender terms and conditions.

1.2. Technical Service

apDia 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.

The technical service of apDia or an authorized service center with specialized technicians, with

suitable instrumentation and original spare parts only, is always available for extraordinary

maintenance (repair), under a yearly maintenance contract or on specific demand.

1.3. Contacts

Advanced Practical Diagnostics n.v.

Hertoginstraat 82

2300 Turnhout

Belgium

Tel: 0032/14453599

Fax:0032/14812945

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01.09.2009/ Version 00 Page 6 of 113

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.

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01.09.2009/ Version 00 Page 7 of 113

2.1. Use of the Instrument

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

proper procedures and safety rules by qualified personnel.

This manual contains instructions for operation performed by qualified personnel.

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).

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

parts according to the given instructions.

Maintain room temperature and humidity as specified in the manual.

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

may be impaired.

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

instrument, and for the deriving consequences.

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.

This IVD equipment complies with the emission and immunity requirements as per IEC61326

series.

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."

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

the device.

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.

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01.09.2009/ Version 00 Page 8 of 113

3. INTRODUCTION

3.1. Description

A. D. TOUCH is a user-friendly micro plate Analyzer. 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 A. D. TOUCH 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 itself 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 A. D. TOUCH operates on a WIDE voltage (90-270 volt). This eliminates the need for an

external voltage stabilizer.

The A. D. TOUCH has a special provision, which allows it to be used even when a printer is not

available. Readings can be conveniently noted down manually, by using the PAUSE option

(Ref. 8.4)

The other special features of A. D. TOUCH are the following:

o Option of Lamp saving mode.

o Selection of both primary and secondary filters.

o Latest technology with battery back up for 250 tests with QC, more than 2500

result.

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

o Unique circuitry for long lamp life.

o Alphanumeric Patients ID entry.

o Editing of saved tests.

o Human machine user interface: Touch panel, Keypad

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

o Access to test by touch of key.

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

o Blank is optional.

o Setting of the Date and Time.

o Capable of storing, deleting and recalling tests.

o Multiple calibrator modes.

o Selection of duplicates for both calibrators and samples.

o Extensive software for cut off mode.

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

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01.09.2009/ Version 00 Page 9 of 113

o 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.

o ABSORBANCE MODE

o CUT-OFF MODE

o MULTISTANDARD MODE

o SINGLE CALIBRATOR MODE

o % ABSORBANCE MODE

o UPTAKE

o KINETIC

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01.09.2009/ Version 00 Page 10 of 113

3.3. Technical Specification of A. D. TOUCH

Human Machine Interface TOUCH PANEL / KEYPAD

Linear measurement range 0.000 to 3.000 Absorbance Units (A).

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, & Two Optional

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

Plate Carrier Movement Precisely through the stepper motor

Printer

Memory

Built in Thermal Printer 52 columns

64 KB Non Volatile RAM Battery

backup supporting

125 open channels

Connectivity / RS232 Serial Port/USB 9600 baud, 8 data, 1 stop, no parity bits / USB

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01.09.2009/ Version 00 Page 11 of 113

Analysis Mode Absorbance

Cut-off

Multi-Standard

% Absorbance

Difference

Uptake

Kinetic

Power

Wattage

Voltage

75 Watts

115-230 Volt ± 10%, 50/60 Hz

Operation Position On horizontal flat, rigid and vibration free surface

Operating Conditions

Temperature

Relative Humidity

From + 18°C to 35°C

Up to 80%

Storage Conditions

Temperature

Relative Humidity

From -10°C to 40°C

Up to 80%

Enclosure ABS Fire Retardant

Size (cm) 36 x 36 x 22 (lxbxh)

Weight (Approx) 10 Kg

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01.09.2009/ Version 00 Page 12 of 113

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:

o Decontaminate the instrument as explained on decontamination chapter of this

manual

o 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)

o 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 has to be less than 85%, and temperature between -10ºC and 40ºC.

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5. INSTRUMENT DESCRIPTION

5.1. Instrument Working Principle

o Switch on and program the instrument.

o Place the plate firmly onto the carriage.

o 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.

o 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.

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5.2. Perspective View

Front View:

Plate Carrier/ Holder

Keypad

Touch

Screen

Printer

Amplifier

Analogue to Digital

Converter

Micro Processor

Key Pad Touch Panel Printer RS232 Display

Lamp

Lens

Lens

Lens

Photo sensor

Memory

Filter

Wells

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01.09.2009/ Version 00 Page 15 of 113

5.3. Rear View:

1) Contrast Knob-use to adjust display contrast

2) Serial RS232 output

3) Cooling Fan

4) USB output

5) ON/OFF switch

6) SMPS

7) External printer connection

1

2

3

4

5

6

7

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01.09.2009/ Version 00 Page 16 of 113

5.4. Keypad

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) ‘FEED’ key is used to forward the paper in thermal printer by one print line.

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.

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) ‘FEED’ key is used to get a printout of current screen displayed

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) ‘HOME’ key is used to bring plate carrier at home position. But this key is not active.

This function will not work.

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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.

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6.5. Printer

A. D. TOUCH ELISA Analyzer 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.

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01.09.2009/ Version 00 Page 19 of 113

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.

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01.09.2009/ Version 00 Page 20 of 113

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.

“DEL”: Deletes the selected test.

If the number of tests is more than 10, “NEXT” and “PREV” can be used for browsing

through the list pages

“PRINT”: For printing the test screen.

6.6. Start up Instructions

Switch on the instrument.

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

displays the following :“Please wait system initializing.”

The instrument will print the model name “A.D. TOUCH”, VERSION NUMBER, CLINIC NAME

CURRENT DATE WITH TIME.

A. D. TOUCH

apDia,

Advanced Practical Diagnostics n.v.

Hertoginstraat 82

2300 Turnhout

Belgium

A. D. TOUCH Date

Clinic name / Serial Number

MENU

Select Test SEL

1. HBSAg 6. HIV

PRNT

2. HCVAb 7. CRP

NEXT

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01.09.2009/ Version 00 Page 21 of 113

6.7. Touch Panel Check

A. D. TOUCH 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

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 analyzer 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 onscreen 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.

Name: POS- CutOff

Pri: 405 Sec: 0 ESC

EDIT

No Factor QC QCVal Mes. Rem RUN

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 Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

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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.

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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

Total number of 20 controls can be run in any combination.

Pipetting sequence should be as shown below.

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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.

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.

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

read any wells containing bubbles or dust particles.

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.

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.

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

the A.D. TOUCH has been designed in such a way that the micro wells are totally

protected from scratches.

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

Place Plate carefully on the tray.

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

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

Connect the printer only when the instrument is OFF.

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8. PROGRAMMING MODES

8.1. Absorbance Mode

In this mode the instrument gives only absorbance of all wells of plates which containing control,

calibrators and samples.

Programming a New Test:

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

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

MAIN MENU

1 Test Operations ESC

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

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 Mode

1> Absorbance 0

2> Single Standard 0

3> Cut off 0

4> Multi Standard 0

5> Percent Absorbance 0

6> Uptake 0

7> Kinetic 0

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D. Enter “Test Name”

5. Select primary and secondary filter

E. Select primary and secondary filter

F. If blank is required select ”BL”

NORM – ABSORBANCE

Name : BL N ESC

Pri : 405 Sec : 0

NORM

MODE

DIFF

NORM – ABSORBANCE

Name:

ABS 450

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

NORM – ABSORBANCE

Name : ABSORBANCE

BL Y ESC

Pri : 405 Sec : 0

NORM

MODE

DIFF

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.

Pri: 450 ESC

Sec: 630

Select Filter Val:

0 405 450

492 630 XXX

YYY

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01.09.2009/ Version 00 Page 27 of 113

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 In Differential Mode

NORM – ABSORBANCE

Name : ABSORBANCE

BL N ESC

Pri : 405 Sec : 630

NORM

MODE

DIFF

DIFF – ABSORBANCE

Name : ABSORBANCE

BL N ESC

Pri : 405 Sec :630

NORM

MODE

DIFF

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 28 of 113

H. Example Print-out obtained from A.D. TOUCH

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 29 of 113

8.2. Single Standard

In this mode the instrument accepts the calibrator singly or in duplicate and than calculates the

concentration based on the single point standard curve passing through the point 0.0.

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 absorbances

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.

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

of parameters)

Name: TSH SINGLE STANDARD

Pri: 450 Sec: 630 BL Y 0.000 CAL 1 ESC

DUP N DUP N

SAVE

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

High>

Range

Low<

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 30 of 113

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

and 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”

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

Select Test Mode

1> Absorbance 0

2> Single Standard 0

3> Cut off 0

4> Multi Standard 0

5> Percent Absorbance 0

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

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 31 of 113

C. Entry of test name

Select touch Zone “Name:”

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: POS- CutOff

HBSAG

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

Name: POS- CutOff

Pri: 450 Sec: 0 ESC

No

Factor QC QCVal Mes. Rem SAVE

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 Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 32 of 113

D. Selection of Primary and secondary filters.

Select zone “Pri:” on the touch screen

Select the filter required by selecting the filter from Select filter value region after touching ‘Pri”

zone.

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

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 Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

Pri: 450 ESC

Sec: 630

Select Filter Val:

0 405 450

492 630 XXX

YYY

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 33 of 113

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

F. Entry of Blank and Blank QC values

Select “BL” to enter blank details.

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

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 Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 0 Y 0.000 0.000

NC 0 1.000 Y 0.000 0.000

PC 0 1.000 Y 0.000 0.000

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 34 of 113

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

(Maximum 5 blank).

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

No. of Blanks = 1 ESC

Values Of BL <= 0.000

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

No. of Blanks = 1.000 ESC

Values Of BL <= 0.100

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 35 of 113

I. Entry of Negative control and its QC values

Select touch Zone “NC”

J. 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”.

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

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 Interpretation:

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

No. of NC’s = 3 ESC

Values Of X = 1.000

Value of NC <= 0.150

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 36 of 113

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

L. Entry of Positive Controls (PC).

Select touch Zone “PC”.

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No

Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 0 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No

Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 0 1.000 Y

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N Interpretation:

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 37 of 113

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”.

N. After entering the details of PCs, escape from the screen by selecting “ESC”. Below screen

will appear on the display:

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

(Cut of Controls).

No. of PC’s = 2 ESC

Values Of Y= 1.000

Value of PC >= 0.500

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No

Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 38 of 113

O. Entry of Cut off Factor:

Select touch Zone “CUT FAC”

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

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.000

CUTABS:

QC1 N Interpretation:

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

Value of Cut Factor = 0.200 ESC

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 39 of 113

P. Entry of Cut off absorbance equation:

Select touch Zone “CUTABS”

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

Enter the equation as given in the reagent manual.

NC = Mean of NCs * Factor X

PC = Mean of PCs * Factor Y

CUTABS:

CUT ABS =(0.45 * NC) + (0.35 * PC) + 0.10 ESC

NC PC LC CC CF ENTER

+ - , * % CLEAR

1 2 3 4 5 6

7 8 9 0 .

( )

Sqrt Lg ALg Ln ALn Abs

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS:

QC1 N Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 40 of 113

LC = Mean of LCs * Factor W

CC = Mean of CCs * Factor Z

CF = Cut off Factor

Sqrt = Square root

Lg = LOG ALg = Anti LOG

Ln = Natural LOG Aln = Anti Natural LOG

Abs. = any absolute value

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 and 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),

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 41 of 113

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.

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.

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

equat’.

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

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

QC1 > Y Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

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01.09.2009/ Version 00 Page 42 of 113

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.

Enter QC Value and Equation:

QC1 Value: 0.500 ESC

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 ESC

QC1 Equat

QC Equat: PC - NC

NC PC LC CC SA ENTER

+ - , * % CLEAR

1 2 3 4 5 6

7 8 9 0 .

( )

Sqrt Log ALog Ln ALn Abs

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 43 of 113

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)’

Name: HBSAG POS- CutOff

Pri: 450 Sec: 630 ESC

No

Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500 Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

Enter % Value :

% Value = 10.00 ESC

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Enter Greyzone percentage value

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.

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 44 of 113

NOTE: If you don’t select any option for interpretation of

sample results, the instrument will take Cutoff Absorbance

s a reference.

It will give “Positive’ remark to sample absorbance greater

than cutoff and ‘Negative’ to sample absorbance less than

cutoff.

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: CPC POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500 Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

Name: CPC POS- CutOff

Pri: 450 Sec: 630 ESC

No

Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500 Interpretation :

QC2 N Greyzone % (Y) 10.00

QC3 N Cut off Index (N)

QC4 N Range

In case of ‘Greyzone’, it gives the

‘Positive’ remarks to sample

absorbance greater than greyzone

area of cutoff absorbance and a

‘Negative’ remarks to sample

absorbances less than greyzone

area of cutoff absorbance. The

sample absorbances lying in

greyzone area get remarks

‘Equivocal’ = ‘EQ’.

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.)

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 45 of 113

RESULT RANGE:

POSITIVE >= 1.000 ESC

NEGATIVE <= 0.900

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

In case of ‘Cutoff Index Range ’,

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’.

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 46 of 113

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

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500 Interpretation :

QC2 N Greyzone % (Y) 10.00

QC3 N Cut off Index (N)

QC4 N Range

Name: CPC POS- CutOff

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

CUTABS: NC + PC + CF

QC1 > Y 0.500 Interpretation :

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.

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 47 of 113

T. Example Print-out obtained from A.D.TOUCH

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 48 of 113

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.

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 of normal

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

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.

Name: REV- CutOff

Pri: 450 Sec: 0 ESC

No

Factor QC QCVal Mes. Rem SAVE

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 Interpretation :

QC2 N Greyzone % (Y) 10.00

QC3 N Cut off Index (N)

QC4 N Range

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 49 of 113

Programming a New Test:

A. Select Main Menu/Test Operation/Add New Test

B. Select Touch Zone “Multi Standard”

Select Test Mode

1> Absorbance 0

2> Single Standard 0

3> Cut off 0

4> Multi Standard 0

5> Percent Absorbance 0

6> Uptake 0

7> Kinetic 0

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

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 50 of 113

After selecting the Multistandard mode below screen will come on the display

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: MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

Name: TSH MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 51 of 113

After selecting the Zone “Pri:” below screen will come on the display

Select the filters as per details given in the reagent manual by selecting the filter number given in

the “Select Filter value:” option.

E. Selection of Blank

Select Touch Zone “BL”

Pri: 450 ESC

Sec: 630

Select Filter Val:

0 405 450

492 630 XXX

YYY

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 52 of 113

Instrument will display the message “Blank required Yes/No”. At the bottom of the Screen as

shown below, select yes if blank is required.

F. Entry of Standard Concentration

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

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL N 0.000 CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

YES

Blank Required ?

NO

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 53 of 113

After selecting “CAL” the following screen will appear on the display:

Select Touch Zone “No. Of Calibrators”. Numerals will display on the bottom of the screen.

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

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 ascending or descending order.)

No Of Calibrator 2 ESC

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

No Of Calibrator 7 ESC

No Conc Abs

1 0.000 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

7 15.00 0.000

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

User Manuall A..D.. TOUCH

01.09.2009/ Version 00 Page 54 of 113

Programming Screen after Entry of standards.

G. Selection of Duplicate Blank and calibrators

For Duplicate Blank:

Select touch zone “DUP” below the “BLN”

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

Name: TSH MULTISTANDARD

Pri: 450 Sec: 630 BL Y 0.000 CAL 7 ESC

DUP N DUP N

Graph : LINEAR SAVE

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

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01.09.2009/ Version 00 Page 55 of 113

After selecting “DUP” instrument will display message “ Duplicate Blank Yes/No” as shown

below. Select “Yes” for Duplication of Blank.

For Duplicate Calibrators:

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

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

YES

Duplicate Blank?

NO

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

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01.09.2009/ Version 00 Page 56 of 113

After selecting “DUP” instrument will display message “Duplicate Calibrator Yes/No” as

shown below. Select “Yes” for Duplication of calibrator.

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

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

YES

Duplicate Calibrator?

NO

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL Y 0.000 CAL 7 ESC

DUP Y DUP Y

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

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H) Linear mode and Point to Point mode

There are two types of graphs in Multistandard

Linear (LINEAR)

Point to Point (PT TO PT)

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: MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

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01.09.2009/ Version 00 Page 58 of 113

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.

Point-to-Point Graph Type:

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

Graph : LINEAR ESC

Y vs X : ABS vs CONC

TYPE SCALE

LINEAR LOGABS vs CONC

ABS vs LOGCONC

PT TO PT LOGITABS vs LOGCONC

ABS vs CONC

LOGABS vs LOGCONC

Graph Type : PT TO PT ESC

Y vs X : ABS vs CONC

TYPE SCALE

LINEAR LOGABS vs CONC

ABS vs LOGCONC

PT TO PT LOGITABS vs LOGCONC

ABS vs CONC

LOGABS vs LOGCONC

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Select the scale type touching the required zone.

I. Selection of Controls

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

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

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

YES

High Control Required?

NO

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : PT TO PT

Y vs X : ABS vs CONC

HI CO : N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

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01.09.2009/ Version 00 Page 60 of 113

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

Enter High Range Value: ESC

High 25.03

Low 10.54

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>25.03

Low<10.54

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

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01.09.2009/ Version 00 Page 61 of 113

For Low control select zone ‘LO CO: N’ It will ask “Low Control Required? Yes / No”.

Select ‘YES’

Enter the range ‘High’ and ‘Low’ as per the reagent manual.

Name: MULTISTANDARD

Pri: 405 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>25.03

Low<10.54

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

YES

Low Control Required?

NO

High> 16.61 ESC

Low< 5.45

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

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J. Normal Range selection for interpretation of samples:

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

REAGENT MANUAL. Select key “Interpretation: N”. It will become “Interpretation: Y”.

Then select key “HIGH>” and “LOW<” to enter normal range.

Enter Normal Range for positive and negative samples.

Name: MULTISTANDARD

Pri: 0 Sec: 0 BL N CAL 2 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs X : ABS vs CONC

HI CO : N High>25.03

Low<10.54

LO CO: N High>16.61

Low<5.45

Interpretation: N

Range High>

Low<

Enter HIGH Range value:

High> 15.25 ESC

Low< 9.46

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

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’.

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

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

Name: TSH MULTISTANDARD

Pri: 450 Sec: 630 BL Y 0.000 CAL 7 ESC

DUP N DUP N

SAVE

Graph : LINEAR

Y vs. X : ABS vs CONC

HI CO : N High>25.03

Low<10.54

LO CO: N High>16.61

Low<5.45

Interpretation: Y

Range High> 15.25

Low< 9.46

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J. Example Print-out obtained from A.D.Touch

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01.09.2009/ Version 00 Page 65 of 113

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.

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 0.0.

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

Sample Absorbance

Please refer single standard for parameter entry.

Name: TSH % ABSORBANCE

Pri: 450 Sec: 630 BL Y 0.000 CAL 1 ESC

DUP N DUP N

SAVE

HI CO: N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

Name: TSH UPTAKE

Pri: 450 Sec: 630 BL Y 0.000 CAL 1 ESC

DUP N DUP N

SAVE

HI CO: N High>

Low<

LO CO: N High>

Low<

Interpretation: N

Range High>

Low<

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8.8. Kinetic mode of Operation

To create a new test in “KINETIC” mode.

Read Time” is total read period of

whole test. You need to enter it only in

minutes.

“Read Period” is time interval between

two readings. You must enter it in

seconds. The instrument will

automatically calculate the number of

readings. Select primary and secondary

filters, give a name to test and save it.

To run the kinetic test.

Select “RUN” to start.

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.

KINETIC

Name : KINETIC ESC

Pri : 405 Sec : 0 SAVE

Read Time : 1 min.

Read Period : 15 sec.

KINETIC

Name : KINETIC ESC

Pri : 405 Sec : 0 EDIT

Read Time : 1 min. RUN

Read Period : 15 sec. PRINT

Name: KINETIC KINETIC

Pri : 405 Sec : 630

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

YES

Is Plate Loaded

NO

ESC PRINTMATRIX SEND PLATE LOAD NEXT

Name: KINETIC KINETIC

Pri : 405 Sec : 630

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

YES

Is Plate Removed

NO

ESC PRINTMATRIX SEND PLATE LOAD NEXT

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01.09.2009/ Version 00 Page 67 of 113

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

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 absorbances.

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..

Using “SEND PLATE” you can send plate data to computer using either USB or SERIAL RS232.

“LOAD NEXT” uses to get the absorbance of next plate.

Name: ABSORBANCE NORM – ABSORBANCE

Pri : 405 Sec : 630 BL N

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

1 2 3 4 5 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 D/M D/M D/M D/M

7 8 9 10 11 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

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01.09.2009/ Version 00 Page 68 of 113

Example Print-out obtained from A.D.Touch

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01.09.2009/ Version 00 Page 69 of 113

9. RECALLING AND RUNNING OF STORED TEST/PROGRAMS

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

The entire saved tests are available on first screen; tests can be selected from this screen also.

A. D. TOUCH 01/01/08

ABCDEFGHIJKLM

Select Test MENU

1 HBSAG SEL

PRNT

2 TSH NXT

PREV

3.ABSORBANCE DEL

MAIN MENU

1 Test Operations ESC

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

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

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01.09.2009/ Version 00 Page 70 of 113

9.1. Absorbance Mode:

Select the test by “SEL” option.

Below screen will appear on the display after selecting the Run display.

The instrument will ask “Is Plate Loaded? YES / NO” Press Yes. Instrument will read the

absorbances using mechanical plate movement. After completion of reading it will ask:

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

NORM – ABSORBANCE

Name : ABSORBANCE

BL N ESC

Pri : 405 Sec : 630 EDIT

NORM RUN

MODE

DIFF PRINT

Name: ABSORBANCE NORM – ABSORBANCE

Pri : 405 Sec : 630 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

YES

Is Plate Loaded

NO

Name: ABSORBANCE NORM – ABSORBANCE

Pri : 405 Sec : 630 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

YES

Is Plate Removed

NO

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01.09.2009/ Version 00 Page 71 of 113

Details of absorbance of all well in table format for each strip will display on the screen as shown

below.

In this operation if you keep BLANK

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 o.650..

Using “SEND PLATE” plate data can be

sent to computer using either USB or

SERIAL RS232.

“LOAD NEXT” uses to get the

absorbance of next plate.

Name: ABSORBANCE NORM – ABSORBANCE

Pri : 405 Sec : 630 BL N

ABS ABS ABS ABS ABS ABS

1 2 3 4 5 6

0.125 0.250 0.350 0.450 0.550 0.650

-- --

--

--

--

0.125 0.250 0.350 0.450 0.550 0.650

ABS ABS ABS ABS ABS ABS

7 8 9 10 11 12

0.125 0.250 0.350 0.450 0.550 0.650

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Differential Absorbance Mode: In differential absorbance mode the instrument will give the

absorbance difference each set of “ODD” number strip and EVEN number strip.

It is showing the absorbances 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 0.200 0.100 1.200 0.300

2.600 0.900..

0.000 0.100 0.000 0.900 0.000

1.700..

B

W1 W2 W3 W4 W5

W6 0.300 0.100 1.200 0.200 2.600

0.800..

0.000 0.200 0.000 1.000 0.000

1.800..

Name: ABSORBANCE NORM – ABSORBANCE

Pri : 405 Sec : 630 BL N

ABS ABS ABS ABS ABS ABS

1 2 3 4 5 6

0.100 0.900 1.700

0.200 1.000 1.800

0.300 1.100 1.900

0.400 1.200 2.000

0.500 1.300 2.100

0.600 1.400 2.200

0.700 1.500 2.300

0.800 1.600 2.400

ABS ABS ABS ABS ABS ABS

7 8 9 10 11 12

0.100 0.900 1.700

0.200 1.000 1.800

0.300 1.100 1.900

0.400 1.200 2.000

0.500 1.300 2.100

0.600 1.400 2.200

0.700 1.500 2.300

0.800 1.600 2.400

ESC PRINTMATRIX SEND PLATE LOAD NEXT

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01.09.2009/ Version 00 Page 73 of 113

9.2. Cut off Mode

A) This test can be started by selecting RUN option. “PRINT” is used to print the details of

test parameters.

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No Factor QC QCVal Mes. Rem SAVE

BL 1 Y 0.100

NC 3 1.000 Y 0.150

PC 2 1.000 Y 0.500

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200

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

QC1 > Y Interpretation :

QC2 N Greyzone % (N)

QC3 N Cut off Index (Y)

QC4 N Range Pos : 0.000

Neg : 0.000

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 0 RUN

DUP N SIMUL PID

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

B

NC

NC

NC

PC

PC

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01.09.2009/ Version 00 Page 74 of 113

B) It shows the 12 strips horizontal with 8 wells vertical with blanks and controls loaded in

first strip. Enter the N° of samples by selecting that option and enter N° of samples you want

to be loaded.

C) After entering N° of samples, press RUN. The plate-loading tray will come out and the

following message will appear: “Is plate loaded? YES / NO”.

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 10 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

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 10 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

YES

Is Plate Loaded

NO

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

The instrument will read the controls and samples.

The following message appears: “Is plate removed? YES / NO”. You remove the tray and press

YES.

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 10 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

YES

Is Plate Removed?

NO

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E) After pressing YES, result screen will appear with the measured values of average blank,

average of all controls and the cut off absorbance.

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No

Factor QC QCVal Mes. Rem ACCEPT

BL 1 Y 0.100 0.050 TEST NC

3 1.000 Y 0.150 0.098

PC 2 0.100 Y 0.500 2.658 PRINT

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200 CUTABS: 0.563 Display

VALUE:

QC1 2.560 QC2

QC3 QC4 LOAD

NEXT

Range % 10.00

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F) To check the results of samples, select option ‘Display value:

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 obtain the print

of the same format by selecting option ‘PRINT RESULTS’. To check the results of next samples,

choose option ‘NXT’, and than 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 A, B, C, D…

WELL NUMBER W1, W2, W3, W4…

WELL ID OR SAMPLE NUMBER BL, NC, PC, OR S1, S2, S3,

PATIENT IDENTIFICATION RAMESH, VIKAS, etc.

WELL ABSORBANCE 0.050, 0.098, 0.085, …

SAMPLE CONCENTRATION 0.738, 0.689, 2.578,…

INTERPRETATION / REMARKS POS or NEG or EQ

Name: HBSAG POS- Cut Off ESC

Pri: 450 Sec: 630 BL 1

Range PERCENTAGE % 10.00 NXT

Pos:0.330

CUT ABS= 0.300 Neg:0.270 PREV

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050

B1 NC

-F1 S1 0.200 0.200 0.254 NEG HIV-1

G1 S2 1.854 1.854 7.245 POS HIV-2

--

PRINT SAVE PRINT PLATE

RESULTS RESULTS MATRIX OPT.

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01.09.2009/ Version 00 Page 78 of 113

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 control. OR if the QC1, QC2, QC3 and QC4, which has another 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 POS- Cut Off

Pri: 450 Sec: 630 ESC

No

Factor QC QCVal Meas. Rem ACCEPT

BL 1 Y 0.100 0.105 HI TEST

NC 3 1.000 Y 0.150 0.200 HI

PC 2 0.100 Y 0.500 0.456 LO PRINT

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200 CUTABS: 0.563 Display

VALUE:

QC1 2.560 HI QC2

QC3 QC4 LOAD Invalid

Assay 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.)

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01.09.2009/ Version 00 Page 79 of 113

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 select touch zone 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’ key to go back.

When you go back, you will get the edited value 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 absorbances 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.

NC VALUE : 0.200

ESC

NC1 0.150 DEL

NC2 0.350 HI

NC3 0.200 HI

NC VALUE : 0.200

ESC

NC1 0.150 DEL

NC2 0.350 HI

NC3 0.200 HI

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01.09.2009/ Version 00 Page 80 of 113

9.2. A. Invalid Assay in Cut Off Mode

9.3 Multi Standard Mode

A) Run this test by selecting RUN option. Following screen will appear.

Name: TSH MULTISTANDARD

Pri: 450 Sec: 630 ESC

No. of samples : 0 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

COL

ROW

Name: TSH MULTISTANDARD

Pri: 450 Sec: 630 BL Y 0.000 CAL 7 ESC

DUP N DUP N

EDIT

Graph : LINEAR

Y vs X : ABS vs CONC RUN

HI CO : N High>25.03 PRINT

Low<10.54

LO CO: N High>16.61

Low<5.45

Interpretation: Y

Range High> 15.25

Low< 9.46

To change values press EDIT

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01.09.2009/ Version 00 Page 81 of 113

B) To enter total N° of HI controls you want to load in the plate select “HI CO:” option and

enter numeric value.

C) If you select N° of HI controls TWO.

Then you have to locate the position of HI controls by selecting column number and row

number.

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

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

Numeric Value

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

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

HI CO : 2

ROW COL

A 2

B 3

Please Enter Row Entry: 1

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D) You have to 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 3, row B for second HI

control than the location of HI control will be display on screen. As shown in screen below.

E) Select N° of samples you want to run. In case of 12 samples, the following screen will

appear.

Name: TSH MULTISTANDARD

Pri: 450 Sec: 630 ESC

No. of samples : 0 RUN

DUP N SIMUL PID

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

Name: TSH MULTISTANDARD

Pri: 450 Sec: 630 ESC

No. of samples : 12 RUN

DUP N SIMUL PID

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

B HC S8

C1 S1 HC

C2 S2 S9

C3 S3 S10

C4 S4 S11

C5 S5 S12

C6 S6

C7 S7

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F) Press run to start reading operation.

The tray will come out. The following message appears: “Is Plate loaded YES / NO”.

The tray has to be loaded in a direction that calibrators should go in first and press YES.

The instrument will read the absorbance of calibrators and samples.

“Is plate removed? YES / NO”. Remove the tray and press YES.

The Tray holder will go inside and on the screen all details of calibrators, samples and controls are

shown.

All the details as per row and column are shown on the screen. The printout of the same format can

be obtained by selecting option ‘PRINT RESULTS’. To check the results of next samples, choose

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

You can get 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 will print

seven different parameters in print matrix for a single well as follows:

Name: TSH MULTI STANDARD ESC

Pri: 450 Sec: 630 BL Y CAL 7

Range High > 16.61 Low < 10.30 NXT

HI CO : High > Low < 0.000

LO CO : High > Low <

PREV

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050 SAVE

B1 C1 0.070 0.070 0.000 RESULT

C1 C2 0.257 0.257 2.500

--

--

--

F1 S1 0.200 0.200 2.100 NEG TSH-1

G1 S2 1.854 1.854 9.845 POS TSH-2

LOAD PRINT PLATE VIEW ACCEPT PRINT

NXT MATRIX OPT. GRAPH: TEST RESULTS

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ROW IDENTIFICATION A, B, C, D…

WELL NUMBER W1, W2, W3, W4…

WELL ID OR SAMPLE NUMBER B, C1, C2, C3, OR S1, S2, S3,

PATIENT IDENTIFICATION RAMESH, VIKAS, etc.

WELL ABSORBANCE 0.050, 0.098, 0.085, …

SAMPLE CONCENTRATION 0.738, 0.689, 2.578…

INTERPRETATION / REMARKS POS, NEG, EQ,

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 ESC

3.000

+ PRINT

EDIT

2.000 +

+

1.000

+

+

0.001 + +

0.000 10.00 20.00 40.00

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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.)

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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.

In such a case “EDIT” option is available on the GRAPH screen. If you select EDIT,

the following screen will appear:

Name: TSH MULTI STANDARD ESC

Pri: 450 Sec: 630 BL Y CAL 7

Range High > 16.61 Low < 10.30 NXT

HI CO : High > Low < 0.000

LO CO : High > Low <

PREV

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050 SAVE

B1 C1 0.070 0.070 0.000 RESULT

C1 C2 0.257 0.257 2.500

--------Invalid Assay

LOAD PRINT PLATE VIEW ACCEPT PRINT

NXT MATRIX OPT. GRAPH: TEST RESULTS

CAL 1 2.562 ESC

CAL 2 1.865

CAL 3 2.050

CAL 4 1.054

CAL 5 0.648

CAL 6 0.356

CAL 7 0.045

CAL 1 2.562 ESC

CAL 2 1.865

CAL 3 2.050

CAL 4 1.054

CAL 5 0.648

CAL 6 0.356

CAL 7 0.045

Numeric Value:

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

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You can easily select any particular calibrator by touching that touch zone and edit the absorbance

of that. After editing the calibrator’s absorbance select “ESC”. A message will appear: “PLEASE

WAIT…” and the modified graph will appear on the screen.

(*NOTE: SAME PROCEDURE CAN BE USED TO CREATE AND RUN THE TEST IN ALL

OTHER MODES, LIKE SINGLE STANDARD, % ABSORBANCE AND UPTAKE.)

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10. RERUNNING ACCEPTED TESTS / PROGRAMS

“ACCEPT TEST” option is used to store the data of controls or calibrators (refer to chapter 9.2,

9.3). 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:

B) In “Multi standard” Mode:

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No

Factor QC QCVal Mes. Rem ACCEPT

BL 1 Y 0.100 0.050 TEST NC

3 1.000 Y 0.150 0.098

PC 2 0.100 Y 0.500 2.658 PRINT

LC 0 1.000 N

CC 0 1.000 N

CUTFAC: 0.200 CUTABS: 0.563 Display

VALUE:

QC1 2.560 QC2

QC3 QC4 LOAD

NEXT

Range % 10.00

Name: TSH MULTI STANDARD ESC

Pri: 450 Sec: 630 BL Y CAL 7

Range High > 16.61 Low < 10.30 NXT

HI CO : High > Low < 0.000

LO CO : High > Low <

PREV

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050 SAVE

B1 C1 0.070 0.070 0.000 RESULT

C1 C2 0.257 0.257 2.500

F1 S1 0.200 0.200 2.100 NEG TSH-1

G1 S2 1.854 1.854 9.845 POS TSH-2

LOAD PRINT PLATE VIEW ACCEPT PRINT

NXT MATRIX OPT. GRAPH TEST RESULTS

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When you want to run such an accepted test, select ‘RUN’ option in test detail screen,

in “CUT OFF” mode:

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 0 RUN

DUP N SIMUL PID

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

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 0 RUN

DUP N SIMUL PID

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

This time, the blank and

controls will not be loaded

directly and you will get the

following question: “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 / graph of

controls select ‘NO’, so that

you can run only samples to get

their results without loading

control and calibrators.

If you want to load only

‘Blank’,select “Load Blank?

YES” and

“Load Controls? NO”.

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

11.SAMPLE AND SAMPLE DUPLICATE

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

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 0 RUN

DUP N SIMUL PID

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

YES

Load Calibrators?

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”.

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”.

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11. SAMPLE AND SAMPLE DUPLICATE

While loading the samples you can load a single sample in single well or a single sample in

adjacent two well and finally instrument takes the average of it; this is 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.

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 0

RUN

DUP N SIMUL PID

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

B

NC

NC

NC

PC

PC

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 0

RUN

DUP N SIMUL PID

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

B

NC

NC

NC

PC

PC

Numeric Value:

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

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Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630

ESC

No. of Smples : 10

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

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If you want to load duplicate samples select “DUP” key, and on the screen ‘N’ change to ‘Y’.

After this, enter number of samples by selecting “No. of Samples”.

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630

ESC

No. of Samples : 0

RUN

DUP Y SIMUL PID

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

B

NC

NC

NC

PC

PC

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630

ESC

No. of Samples : 10

RUN

DUP Y SIMUL PID

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

B

NC

NC

NC

PC

PC

Numeric Value:

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

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(* Same way you load the samples and Sample Duplicates in all other modes)

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Samples : 10 RUN

DUP Y SIMUL PID

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

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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”.

One by one you can enter name of each patient. The character length of PID is only 7 characters.

Go to the next and previous screen with “NEXT” and “PREV”

Name: HBSAG POS- Cut Off

Pri: 450 Sec: 630 ESC

No. of Smples : 10 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

Sample PID ESC

1 KIRAN

2 ABDUL

3 MR. JAME

4 KRISHNA

5

6

7 NEXT

8

9 PREV

10

SEQL

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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 say YES, it will delete the previous PIDs.

After selecting ‘NO’, select “SEQL” option to enter different sequential PIDs. And follow the steps

as follows:

C) Enter Initial Alphabets. Maximum 4 characters

D) Enter Initial well Number. This is the starting well location of that particular batch.

E) Enter last well Number. This is last well location of that particular batch.

Enter Alphabets

HIVA

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

Enter last sample number

Numeric Value: 01

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

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F) Enter initial PID Number. This is the starting number of that particular batch, maximum

3 digits.

The final screen will appear which displays the sequential IDs of patient samples for the well

location that is selected.

In case there are totally 70 N° of samples from three different batches which are loaded in a

single plate, than the PID For the first batch are from HIV 1 to HIV 30, for second batch

PIDs are from HIV 51 to HIV 75 and the third batch has PIDs from HIV 91 to HIV 105.

To enter these PIDs, you have to enter sequential entries three times, use following steps:

Select ‘SEQL’, Enter alphabet ‘HIV’. Enter initial well number ‘1’ and the last well number ‘30’,

after this enter initial PID number ‘1’. It will load PIDs for first 30 samples from HIV 1 to HIV 30.

Enter initial PID number

Numeric Value: 01

1 2 3 4 5 6 ENTER

7 8 9 0 . CLEAR

Sample PID ESC

1 HIV-01

2 HIV-02

3 HIV-03

4 HIV-04

5 HIV-05

6 HIV-06

7 HIV-07 NEXT

8 HIV-08

9 HIV-09 PREV

10 HIV-10

SEQL

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To enter next sequence again select ‘SEQL’, enter alphabet ‘HIV’. Enter initial well number ‘31’

and last well number ‘55’. After this enter initial PID number ‘51’. It will load PIDs for next 25

samples from HIV 51 to HIV 75.

To enter next sequence again select ‘SEQL’, enter alphabet ‘HIV’. Enter initial well number ‘56’

and last well number ‘70’. After this enter initial PID number ‘91’. It will load PIDs for next 15

samples from HIV 91 to HIV 105.

In this way you can select any sequence for any well locations.

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

“Delete previous PIDs? Yes / NO.”)

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13. SAVE PLATE AND SAVE RESULTS

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

A) In cut Off mode:

B) In Multi standard or any calibrator mode:

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

“SAVE PLATE DATA”,

which will save the entire plate information along with the control/calibrator information.

(maximum TEN plates data can be saved).

“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.

Name: HBSAG POS- Cut Off ESC

Pri: 450 Sec: 630 BL 1

Range PERCENTAGE % 10.00 NXT

NO SAMP ABS AVG CONC REM PID PREV

A1 B 0.050 0.050

B1 NC

Name: TSH MULTI STANDARD ESC

Pri: 450 Sec: 630 BL Y CAL 7

Range High > 16.61 Low < 10.30 NXT

HI CO : High > Low < 0.000

LO CO : High > Low <

PREV

NO SAMP ABS AVG CONC REM PID

A1 B 0.050 0.050 SAVE

B1 C1 0.070 0.070 0.000 RESULT

C1 C2 0.257 0.257 2.500

--

1. SAVE PLATE DATA

ESC

2. SEND PLATE DATA

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14.VIEW STORED DATA

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

MENU”.

Two options appears on the screen by selecting “View Plate” option

1) The details of stored plate (last 10 plates) with date, test name and mode of operation in

descending order from last to first will appear on the screen by selecting. “PLATE RESULTS”

Any test can be selected. The complete information will appear on the screen.

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

2.) “PATIENT RESULTS” 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.

MAIN MENU

1 Test Operations ESC

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

1. PLATE RESULTS

ESC

2. PATIENT RESULTS

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

“NEXT” and “PREV” option are used to go to next page of sample details and to go back to

previous page.

(*NOTE: 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 and than

save the new samples at that location.

NO DATE TEST MODE ESC

4 02/01/08 HBSAG C

3 01/01/08 TSH M SEL

2 30/12/07 HIV C

1 28/12/07 HIV C

HBSAG 02/01/08

CUT ABS= 0.300

NO SAMP ABS AVG RES REM PID

01 / 01 / 08

Test Mode Result PID Remarks

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15. UTILITIES

In utilities there are seven different functions

15.1. Date and Time Setting

Set current Date and Time by

Selecting DD, MM, YY and

Hrs, Min, Sec.

MAIN MENU

1 Test Operations ESC

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

UTILITIES Version (RBNK-2.307)

1. Date and Time Esc

2. Program Filter.

3. Printer On / Off : ON

4. Enter Clinic Name

5. Shaker

6. Calibrator

7. Communication Settings: USB

8. CV Diagnostic OFF

Date – DD / MM / YY ESC

01 / 01 / 08

Time – Hrs : Min : Sec

12 : 10 : 10

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15.2. Printer On / Off setting

To turn PRINTER On and OFF.

15.3. Clinic Name Entry.

15.3. Clinic Name Entry

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

UTILITIES Version (RBNK-2.307)

1. Date and Time Esc

2. Program Filter.

3. Printer On / Off : ON

4. Enter Clinic Name

5. Shaker

6. Calibrator

7. Communication Settings: USB

8. CV Diagnostic OFF

A. D. TOUCH

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

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15.4. Plate Shaking Mode (Shaker)

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

number 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”.

After selecting YES the tray will go inside and instrument will do the shaking of plate for the given

time period with selected speed.

When the shaking is finished, the play will come out of the tray and display a message

“Is plate removed? Yes / No “Remove the tray and press Yes to end the process.

Shake Time in 0 sec ESC

Shake Speed 0

Start

Stop

Numeric Value: 01

1 2 3 4 5 6 ENTR

7 8 9 0 . CLR

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15.5. Communication Settings

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.

We provide one application which support to this communication between instrument and

computer. This application receives data either by USB setting or by Serial setting.

NOTE: The option 6. “Calibrator” is not for users. Do not select this utility and don’t change

any settings because otherwise the mechanical alignment will get disturbed.

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

UTILITIES Version (RBNK-2.307)

1. Date and Time Esc

2. Program Filter.

3. Printer On / Off : ON

4. Enter Clinic Name

5. Shaker

6. Calibrator

7. Communication Settings: USB

8. CV Diagnostic OFF

UTILITIES Version (RBNK-2.307)

1. Date and Time Esc

2. Program Filter.

3. Printer On / Off : ON

4. Enter Clinic Name

5. Shaker

6. Calibrator

7. Communication Settings: Serial

8. CV Diagnostic OFF

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16. SERIAL COMMUNICATION

The instrument is equipped with an RS232 serial port.

A.D. TOUCH Date

Clinic Name or Serial Number

MAIN MENU

1. Test Operations

2. Technical Diagnosis

3. Utilities

4. View Plate

5. Serial communications

SERIAL COMM.

ESC

1.Send Results

SERIAL COMM.

ESC

1.Send Results

YES

Results

NO

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17. TECHNICAL DIAGNOSIS

Technical Diagnosis is present in “Main Menu”.

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.

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.

MAIN MENU

1 Test Operations ESC

2 Technical Diagnosis

3 Utilities

4 View Plate

5 Serial Communication

TECHNICAL DIAGNOSIS ESC

1. Clear Memory

2. Lamp Amplitude

3. Printer Self test

TECHNICAL DIAGNOSIS ESC

1. Clear Memory

2. Lamp Amplitude

3. Printer Selftest

YES

Clear Results?

NO

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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.

Filter: 405 ESC

CH1 CH2 CH3 CH4

1800.0 2200.0 1900.0 2300.0

1800.0 2200.0 1900.0 2300.0

CH1 CH2 CH3 CH4

1950.0 2100.0 2240.0 1860.0

1950.0 2100.0 2240.0 1860.0

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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.

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18. TROUBLE SHOOTING

CAUSE /CORRECTIVE ACTION

1) Printer disabled

Disable Printer YES / NO?

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.

2) “Check Light Path!!! CH x”

Where ‘x’ is any channel

number

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

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.

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CAUSE /CORRECTIVE ACTION

5) “Check USB Application on

Computer

Do you want to continue?

YES / NO

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’ communication on

computer data receiving application, you will get this message. In such

a case select ‘USB’ communication, on computer and select ‘YES’ key

to 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!!!

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.

7) Plate Movement Error!!!

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.

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19. DECONTAMINATION

19.1. Decontamination Procedure

If the instrument has to be shipped after being exposed to potential hazard 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 as a biohazard and

should be decontaminated prior to handling. Intact surface is generally considered as an effective

barrier against infectious organisms. However, small abbreviations may not be always being

visible. Gloves must be used incase the instrument is not decontaminated.

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.

Reassemble the unit and discard the used gloves and towels.

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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 cooperation.

Customer Contact

Address Position

Dept

Tel:

Country Fax:

Post Code

Model No. Serial No.

Accessories

Returned

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

b) Other Biohazard *YES/NO

if YES, Please specify