ERBA DIAGNOSTICS MANNHEIM GmbH

Friedrichsring 4 Mannheim, 68161 Germany

Phone: + 49 621 1780960 Fax: + 49 6211780969
Email: [email protected],
Website: www.erbamannheim.com
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 TABLE OF CONTENTS
CHAPTER PAGE NO.
I. OVERVIEW OF ANALYZER………………………………………………………. 6
A. Introduction………..………………...……………………………………………. 6
B. Analyzer View…..….…………………………………………………………….. 7

II. SYSTEM SPECIFICATIONS AND FEATURES………………………………….. 8

A. Hardware Specifications...………………………………………………………. 8
B. Software Specifications………………………………………………………….. 9
C. Keyboard Layout…………………………….……………………………………. 11
D. Keyboard Description…………………………………………………………….. 12
E. Aspiration Switch…………………………..……....……………………………… 14
F. Safety…………………………………..………………….……………………….. 14

III. INSTALLATION………………………………………………….……………………. 16
A. Inspection……………………………………………………..……………………. 16
B. Unpacking……………………………………………….…………………………. 16
C. Installation Requirements…………………………………….…………………... 17
D. Electrical Requirements……………………………………….….………………. 17
E. Installation Procedure……………………………………………………………… 18
F. Printer Installation………………………………………………………………….. 18

IV. PRINCIPLES OF OPERATION………………………………………………………. 22

A. Modes of Operation………………………………………..………….…………… 22
B. The Reading Cuvette……………………………………..………….……………. 23
C. Aspiration Volume………………..………………………………………………… 23
D. Calculation of the Kinetic Test Results……………..……………………………. 24
E. Additional Cuvette Holder………………………….……………………………… 25

V. SETTINGS ………………………………………………...….……………………….. 27
A. Hardware Check…………………………………………………………………….27
B. Main Menu……………………………………………………….…………………..27
C. System Setup ……………………………………………………………………….28
D. Test Parameters….………………………………….………………………………31
E. Parameter Definitions and Values…………………………………………………33
F. Changing the Chemistry Code and Description.…………………………………38
G. Maintenance Mode………………………………………………………………….38

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CHAPTER PAGE NO.

VI MODES OF OPERATION…………………………………………..………………… 41
A. Absorbance Mode…………………………………………………………………. 41
B. 1-Point Linear Mode………………………………………………………………..42
C. 2-Point Linear Mode ……………………………………………………………….44
D. Rate A Linear Mode……………………………………………………………….. 45
E. 1-Point Non Linear Mode…………………………………………………………. 47
F. 2-Point Non Linear Mode…………………………………………………………..50
G. Rate A Non Linear Mode…………………………………………………………..52
H. Coagulation Mode…………………………………………………………………..54
I. Sample Blank……………………………………………..…………………………55
J. Sample Blank Non-Linear……….. ..………………………………………………56

VII. QUALITY CONTROL………………………………………………………………….. 60

A. Daily Quality Control………………………………………….……………………..61

B. Monthly Quality Control…………………………………………….……………….62

VIII. PATIENT REPORT……………………………………………………………………65

A. Collated report by Date……………………………………………………………..65

B. Collated report by I.D…………………………………………………………….....66
C. Collated report by Date and I.D…………………………………………………....67

IX. MAINTENANCE AND ANALYZER CARE……………………………….…………….70

A. Daily Maintenance………………………………………………………..…………70
B. Quarterly Maintenance……………………………………………………………...70
C. Replacement of Tubing……………………………………………………………..71
D. Replacement of Lamp Assembly…………………………………………………..74
E. Replacement of Printer Paper……………………………………………………...75

X. TROUBLE SHOOTING GUIDE………………………………………………………….78

XI. LIST OF CONSUMABLES REQUIRED FOR CHEM-5V3……..……………………..81

User Manual(Ver 0.0 Jun 08) 4

 REVISION RECORD
Version DATE AUTHOR REVIEWER REVISION MADE (Page No.
No. refers to Operator Manual
Page)
0.0 June-2008 Sandhya Nair / Niranjan Initial Release
Rahul Jadhav / Ambikar
Ajay Yadav

CHAPTER I
User Manual(Ver 0.0 Jun 08) 5
OVERVIEW OF ANALYZER
A. INTRODUCTION

The Chem-5 v3 (hereafter referred as an analyzer) is Low Cost, Low Power, Compact, High
performance; 16-bit micro controller based Biochemistry analyzer for Routine Chemistries,
Electrolytes, Hormones, Coagulation and Drug tests.

There are 10 modes of operation. Programming, reading and reporting operations are user
friendly.

The analyzer is provided with memory for storage of Quality Control Data, Reagent Blank
Absorbance, Factor, and Non-linear Calibration Data and up to last 1000 results with Patient
ID. Operation is through a Tactile Keyboard with quick shift from one function to another
without going through complex sequential operations.

The analyzer is provided with a 240X64 dots backlit liquid crystal display with alphanumeric
and graphic capabilities.

A Patient ID wise or Date wise or Patient ID with Date wise collated report can be generated
upon request. Exhaustive Quality Control Data at 2 levels, for any of the tests can be stored
and printed.

The software is complete with the device diagnostic self-test function capable of providing
timely flag / error messages related to Test results or analyzer malfunctioning.

The State-of-the-Art features, advanced optics, versatile analytical capabilities and economy
of 33µl flow cell make it the analyzer of choice for all laboratories.

This analyzer is intended to use,

-For In-vitro quantitative and qualitative determination of wide range of analytes in body fluids
as mentioned above.
-By a trained personnel in controlled environment and continuously monitored operation.

B. ANALYZER VIEW
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 1. PHOTOMETER COVER
2. PRINTER COVER
3. DISPLAY
4. KEYBOARD LEGEND
5. ASPIRATOIN TUBE
6. ASPIRATION SWITCH
7. SIDE CARD
8. PERISTALTIC PUMP COVER
9. PC INTERFACE PORT
10. EXTERNAL USB PRINTER PORT
11. DC INPUT SUPPLY
12. EXTERNAL PC/AT KEYBOARD PORT
13. INCUBATOR CONNECTOR
14. SERIAL NO. PLATE

User Manual(Ver 0.0 Jun 08) 7

 CHAPTER II
SYSTEM SPECIFICATIONS & FEATURES
A. HARDWARE SPECIFICATIONS

1. SYSTEM TYPE : Open, Flow cell.

2. MEASUREMENT PRINCIPLE : Colorimetry (Rate/End Point)

3. APPLICABLE ANALYTES : Photometric assays – Substrates,

Enzymes, Lipid, Protein, Sugar, Inorganic
Substances

4. SETUP : Bench top.

5. LIGHTSOURCE : Quartz Halogen Lamp, 12V, 20 Watts.

6. PHOTOMETRIC RANGE : 0 ~ 2.5 O.D. (Range 340~630nm)

Resolution 0.0001.

7. OPTICS : 6 wavelength static photometric group with

following interference filters: 340, 405, 505,
546, 578, 630 nm.

8. DETECTORS : 6 UV / VIS Silicon photodiodes.

9. CUVETTE : Unique triple cuvette system:

- 33µl Flow cell
- 10 mm rectangular polystyrene cuvette
- Round glass tube with adaptor

10. THERMOSTAT : Peltier temperature control for 25, 30 and

37°C ±0.5°C.

11. FLOW CELL VOLUME : 33µl

12. SAMPLE ASPIRATION : By means of a peristaltic pump, Aspiration

volume programmable from 350μl to 999μl.

13. PRECISION : Better than 1% CV.

14. DISPLAY : High-resolution Graphics LCD 240x64 dots,

with backlit. View area 134mmx40 mm

15. PRINTERS i) Built in High resoluton, 384 dots per line,

thermal type with full graphics facility.

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16. INTERFACES : USB B type port for host computer and
USB A type port for External USB DeskJet
Printer.

17. PROCESSOR : 16-bit with 384KB Flash Memory

18. MEMORY : 2 MB EEPROM, 1MB Serial Flash.

19. REAL TIME CLOCK : Built In.

20 REPLACEABLE BATTERY ON Lithium Battery CR2032 (3v)

PCB:
21 WASTE COLLECTION : Waste collected in closed container.

22. INCUBATOR : Optional external incubator.

23. OPERATING TEMPERATURE : 20-40 Degree Celsius.

24. STORAGE TEMPERATURE : -10 to +50 Degree Celsius.

25. RELATIVE HUMIDITY : Max.80% RH, non-condensing.

26. MAINS SUPPLY : 115/230V AC(±10%), 50/60 Hz(converted

to 18~24V DC using External Universal
SMPS adapter, maxi. power 100W)
27. SIZE : 446 ( W ) x 312 ( D ) x 175 ( H ) mm

28. WEIGHT : Approx 5 Kgs

1) Above specifications subject to change without prior notice.

NOTE: 2) The Manual is based on Software Ver 2008.01.

B. SOFTWARE SPECIFICATIONS

• 10 analytical modes of operation:

- 1-point Linear.
- 2-point Linear.
- Rate A Linear.
- 1-point Non-Linear (Cubic Spline & Point-to-Point).
- 2-point Non-Linear (Cubic Spline & Point-to-Point).
- Rate A Non-Linear (Cubic Spline & Point-to-Point).
- 1-point Sample Blank Linear.
- 1-point Sample Blank Non-linear (Cubic Spline & Point-to-Point).
- Absorbance.
- Coagulation

• 150 totally “OPEN” test programs selectable through keyboard.

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 • Parameters can be viewed, edited, and printed.

• Facility to memorize Reagent Blank ABS., Sample Blank ABS., Standard ABS.,
Factor, Non-linear curve.

• Patient report for last 1000 samples stored in memory are obtained by
- Date.
- I.D.
- Both by date and I.D.

• Graphic presentation of Non Linear calibration curves.

• QC (Levy Jennings Chart available for two controls per test)

- Daily QC
- Monthly QC

• Rate calculation by least square regression method.

• Automatic zeroing of Water OD during Run Test.

• Total reaction time: Selectable delay time between 5 seconds to 999 seconds.
Selectable read time between 5 seconds to 999 seconds.

• Non-linear calibration (6 standards).

• On-line reagent stability check.

• Substrate depletion / Non-linearity check.

• In built reaction non-linearity check.

• Monochromatic as well as bichromatic measurements possible.

• Calibration of peristaltic pump.

• On-line display of cuvette temperature.

• On-line help.

• Self-diagnostics.

• Help messages on erroneous entry.

• Reports can be printed on USB Printer or Thermal Printer by either using PRINT
key or Automatic.

User Manual(Ver 0.0 Jun 08) 10

C. KEYBOARD LAYOUT

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D. KEYBOARD DESCRIPTION

These are multi-function keys. Each key is

used for entering a number seen on the key,
and three alphabets in upper and lowercase.
E.g. The numeric key ‘1’ is used to select or
enter an alphabet or the number ‘1’ in the
sequence: ‘A’, ‘B’, ‘C’, ’a’, ’b’, ’c’, ‘1’ following
every press.

This is a dual function Key.

It is used as <YES>key to save changes in
parameters.
It is used as <DECIMAL>key when entering
numerical parameters.
This is a dual function Key.
It is used as <NO>key to reject changes in
parameters value or to skip aspiration of
analytes. It is used as <0>key while entering
numerical parameters.
It is used to advance the thermal printer paper
roll by few lines and is operational in most of
the menus.

This key is a multi-purpose key used for

different functions and different screens.

For Linear test, CALIB. key is used when

factor is to be calculated by running sample as
standard.
For nonlinear test it is used to calibrate curve.

This key is used to enter the negative sign.

This key is also used as READ key to take
reading from Rectangular Polystyrene or round
cuvette in place of flow cell, avoiding use of
ASP switch.
This key is used to return to the previous
screen.

User Manual(Ver 0.0 Jun 08) 12

 This key is used as key to cancel a typed
character.

This key is used to display help menu

This key is used to reset the instrument

without resetting the memory. When this key
is pressed the instrument stops any test that
it is performing and goes back to the starting
mode.

This key is used to print data on selected

Printer (USB Printer or Thermal Printer or
Both).

These four keys with arrows are used to bring

the cursor to the required position on the
screen.
Enter:-This key is used to select a chemistry,
to display test parameters, to run the test or for
QC reports.

User Manual(Ver 0.0 Jun 08) 13

E. ASPIRATION SWITCH with LED

F. SAFETY

This section provides safety information about analyzer. Use this product
properly and safely to prevent injuries and or damage to property. User
must read this safety precaution before installation/use and follow the
directions.

GENERAL SAFETY:

• While operating, maintaining, servicing or repairing the system, follow all

procedures described in this manual.

• Always ensure that mains switch is off while

a) Connecting or removing or servicing the analyser.
b) Replacing the fuse, in mains connection.

• Observe all WARNINGS and CAUTIONS labels posted on the system or

described in this manual.

• Never use substitute parts or modify it in anyway.

CAUTION: DO NOT OPERATE ON A WET OR DAMP SURFACE

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 CHAPTER III
INSTALLATION
A. Inspection:
The analyzer is tested before shipment and is packed carefully to prevent any
shipping damage. It is user responsibility to inspect all cartons upon arrival and notify
the carrier of any apparent damage. Follow the steps described in the paragraphs
below to install the analyzer.

B. Unpacking:

The main unit and accessories are packed in single cartons. Reagents and other
additional accessories such as Power Adaptor, power cord may be packed in another
carton. The representative is responsible for unpacking, installing and initial setting
up of the analyzer.
***Following is the list.

SR NO ITEM CODE DESCRIPTION QTY NOS

1 LEAOT000164NIAN STANDARD ACCESSORIES 1 SET
2 RMECO000053PMCN DUST COVER 1 NOS
3 RLCOT000004NIBN RECTANGULAR POLYSTYRENE MICRO CUVETTE 5 NOS
4 RCNLT000112NLBN USER MANUAL (CHEM5V3 - EXPORT) VER. 1.0 1 NOS
GERMAN TYPE POWER CORD (2 PIN) AS PER SAMPLE
RELEA000588NIBN
5 APPRO 1 NOS

6 RCNTP000005NLCN THERMAL PRINTER PAPER ROLL(57mm x 30M) 1 KIT

7 LMAPM000019NIAN P.M.KIT 1 NOS
8 LEAOT000087NIBN WASTE B0TTLE ASSEMBLY 1 NOS
9 LMAPM000019NIAN P.M.KIT -CONSISTING OF 1 NOS
a LMACH000004NIAN LAMP ASSY 1 NOS
b RMESY000013NLAN SYRINGE 5 ml ( for cleaning ) 1 NOS
c RTBPV000001NLCN TUBE PVC (ID: 2.8mm; OD: 4.3mm)( WASTE TUBE) 0.55 MTR
d RTSSY000240NIAN Tube Teflon 0.75mmx1.5mm (442-5409-4) 0.21 MTR
e RELTB000007NIBN TUBE TEFLON ( ID: 1mm; OD: 2mm ) 0.027 MTR
f LMATU000014NEBN PERISTALTIC TUBE ASSEMBLY 2 NOS.
SILICON TUBING ID 2 MM X OD 4 MM
RTBSI000013NICN 0.36 MTR
g (USED WITH SYRINGE FOR CLEANING)
Tube Silicon (ID-0.8mm, OD-2.4mm) (to be used with 40mm
RTBSI000004NLCN 0.012 MTR
h flanged teflon tube)
i RTSOT000056NICN O RING FOR HELLMA FLOWCELL 2 Nos.

RTSOT000058NIBN WASHER FOR HELLMA FLOWCELL 2 Nos.

j

*** Please refer to dispatch note for detailed checklist.

User Manual(Ver 0.0 Jun 08) 16

 C. Installation Requirements:

The proper location is an important consideration; a poor location can lead to

malfunction of the analyzer. Please follow our environmental and electrical
suggestions to ensure the accuracy and precision of the analyzer and to maintain a
high level of safety of your personnel.

Since the analyzer is comparatively smaller, it can be comfortably accommodated on

any standard sized table.

Remember that a minimum 30cm. space is maintained between the rear panel and
the wall to allow for heat dissipation. The waste and Water bottle should be placed
on the same level as the analyzer.

PROBLEM resulting from the relocation of the analyzer done by unauthorised

service representative are not covered under warranty.

D. Electrical Requirements:

Voltage & Frequency : Single phase continuous stabilized AC 115/230

volts ± 10%, 50 / 60 Hz.

Grounding : Perfect earthing must be provided at power source

with all applicable local requirement (A grounded,
power plug only should be used). The Voltage
between earth and neutral should not exceed
more than 5 V.

Plug Points : 1 No. of 15/5 Amps outlet and 2 No. of 5 Amp

sockets should be available near the mounting
desks. (Normally only one socket is required per
analyzer and 2 extra sockets are recommended
for using any measuring equipment and
engineering tool if required while servicing. Failure
to properly ground the analyzer bypasses
important safety features and may result in an
electrical hazard. Heavy duty electrical devices
like Air-conditioners, Refrigerators, Oven,
Centrifuge etc., should not be operated on the
same electrical lines as the analyzer. The mains
connection should be easily accessible, for
emergency switch off.

User Manual(Ver 0.0 Jun 08) 17

 E. Installation Procedure:

1. Unpack the accessory box.

2. Remove the waste bottle and place it on the table.
3. The analyzer comes equipped with an external AC power adapter and one
three/two pin power cord (with earth terminal) for external AC power adapter.
4. Proper use of the appropriate power cord assures adequate grounding for the
system. Failure to properly ground the analyzer bypasses important Safety
features and may result in an electrical hazard.
5. Connect the 3/2 pin cord (with earth terminal) of the external SMPS to the
mains socket & check the output of the SMPS it should be 18~24V DC +/ -
0.5 V DC.
6. Connect the Peristaltic Pump tubing correctly & place the end of the
peristaltic pump tubing coming out of the analyzer into the waste bottle
provided for collecting the waste.

F. Printer Housing And Printer Paper Installation :

INTERNAL PRINTER Installation

It is thermal paper housed inside chassis. It is extremely low noise printer. The non-
presence/improper installation (printer lever is not pressed downward) of paper is
detected and it is alarmed by two beeps and probable cause of beeps, message
displayed on the screen.
To place/replace the paper roll, lift out off the printer cover, lower the release lever
and remove the old roll spindle, which is anchored inside the paper- holder housing.

Then take a new paper roll and lay down into the paper roll housing.

User Manual(Ver 0.0 Jun 08) 18

 Release the printer lever by pulling it upward

Cut the one end of the new paper roll as shown in figure, and slip the point of the
paper under the black rubber roller so that the paper comes out of the upper part
and then press the lock lever. If necessary, use the “PAPER FEED “key once the
paper is properly aligned.

Close the printer cover.

WARNING: BEFORE REMOVING COVER SWITCH OFF POWER SUPPLY

!

The thermal paper used must match the specification of the original one,
NOTE : since the calibration of the working temperature is optimized for that kind of
paper. Failure to use proper quality of paper may permanently damage the
printer.

User Manual(Ver 0.0 Jun 08) 19

 EXTERNAL PRINTER INSTALLATION:
HP DeskJet (USB) Printer can be attached to the analyzer to print reports, graphs etc.
USB A type connector is provided at the rear of the analyzer. Connect the printer
cable to this port before switching ON the analyzer.

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 CHAPTER IV
PRINCIPLES OF OPERATION

A. MODES OF OPERATION: The analyzer is capable of performing analysis using

the following modes

ABSORBANCE MODE:
The optical density reading in the range of 0 – 2.5 ABS. can be obtained directly
on the analyzer by selecting appropriate wavelength.

ONE POINT LINEAR MODE:

Results are directly obtained after the analyzer has been calibrated using a
standard /calibrator of known concentration or using factor. This mode is used for
all routine End-Point assays. Calibration can also be performed during Sample
and Control run.

TWO POINT LINEAR MODE:

Two readings at any fixed interval are used for the calculation of results in this
mode. It is also referred to as Pseudo Kinetic assay. Results are directly
obtained after the analyzer has been calibrated using standard/calibrator of
known concentration. Calibration can also be performed during Sample and
Control run.

RATE A LINEAR MODE:

The change in absorbance over a given time is monitored and recorded to
calculate the result of any Enzymatic reaction in this. The result obtained is
followed by a graphic representation of the reaction. This mode is used for
kinetic assays.

CONCENTRATION (NON-LINEAR) MODE:

The concentration is obtained from a non-linear graph, plotted by the analyzer
using standards (maximum of six standards and minimum of 3 standards).These
standards should either be with increasing or decreasing concentrations
including the reagent blank.
The concentration (non-linear) mode is of the following types:
1. One Point Non-Linear
2. Two Point Non-Linear
3. Rate A Non-Linear
4. Sample Blank Non-Linear

SAMPLE BLANK LINEAR MODE:

In this mode the concentration of the sample is obtained after sample blanking. This
mode is generally used for those tests whose results are greatly affected by Icteric,
Lipemic or Hemolysed samples. The sample absorbance is obtained after
subtraction of sample blank absorbance.

User Manual(Ver 0.0 Jun 08) 22

 COAGULATION MODE:
This mode is used for performing common Coagulation tests like Prothrombin
Time (PT) or activated partial thromboplastin time (aPTT). The final result is
obtained in seconds.

B. THE READING CUVETTE: The internal volume of the flowcell is 33 μl. The
flowcell reads the absorbance, change in absorbance for different reaction
mixtures. The flowcell is inserted inside a block, which is heated in metallic
thermostat by peltier effect. The light beam from the halogen lamp enter the
transparent wall of the flowcell and reads the absorbance of the solution. This is
also referred to as reading area of the flowcell; the path length is 10 mm or 1 cm.

The diagram of the flowcell is as shown below:

The user is provided with the option of using Rectangular Polystyrene Cuvette or
Round, Reusable, 6 mm Glass Tubes with adaptor as a reading cuvette in place of
Flowcell.

C. ASPIRATION VOLUME

The aspiration volume is programmable from 350 – 999 ul. After aspiration of
sample an air aspiration of 100 ul has been provided.

User Manual(Ver 0.0 Jun 08) 23

 For Rate A and Two Point mode, extra 150µl air is aspirated after displaying
the result.
Note: It is recommended to use an aspiration volume of at least 400ul for
better accuracy.

D. CALCULATION OF THE KINETIC TEST RESULTS

The Kinetic test results are derived from mathematical calculations, which
guarantee high reliability of the data.
The sample under examination may be measured after three seconds from the
end of the aspiration into flowcell. The actual readings starts after the incubation
time (Absorbance at the first reading time is considered as the initial absorbance,
i.e. after the end of incubation), these readings are stored in the memory at the
rate of one reading every second during the whole period of the analysis. All the
acquired values describe a curve, which will be divided into as many segments
as are delta absorbance values, which have been chosen by the number entered
in the parameter “READ T/NO” (i.e. Read Time Interval/Number of readings)
The result of the analysis is obtained by use of linear regression equation,
performed on the extremes of these segments.

An example of a linear regression diagram

ABS
A4

A3

A2

A1

0
t1 t2 t3 t4 TIME

User Manual(Ver 0.0 Jun 08) 24

E. ADDITIONAL CUVETTE HOLDER

The analyzer’s main cuvette holder can accommodate 3 types of cuvette namely the
• 33µl flowcell.
• Rectangular Polystyrene Cuvette
• Round, reusable, 6mm glass tube with adapter for coagulation

The analyzer is also provided with one Additional Cuvette Holder to hold the Flowcell
when either Rectangular Polystyrene Cuvette or the glass tube adapter is used as
reading device in the main cuvette holder.

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 CHAPTER V
SETTINGS
A. HARDWARE CHECK

** HARDWARE CHECK **
PHOTOMETER FILTER

MEMORY <√> 340<√> 405<√>

PUMP CALIB <√> 505<√> 546<√>
TEMP.SENSOR<√> 578<√> 630<√>

It is self-diagnostic test of the analyzer hardware. Before starting any test on the
analyzer. Hardware check window should show all the test parameters ok results
as <√>. If any one or multiple parameters are showing not ok<X> then analyzer
will display message PROCEED... <YES> asking user to proceed by pressing
<YES> key.

B. MAIN MENU:

Switch ON the analyzer by following the instructions as mentioned in the

installation section. Ensure that the voltage between earth and neutral should not
exceed 5 V. The following display appears:

Erba CHEM5V3
DATE: 21/06/07 TIME:09:57:45

1 RUN TEST 2 TEST PARAMETERS

3 Q.C. REPORTS 4 MAINTENANCE
5 PATIENT REPORTS 6 SYSTEM SETUP

<WASH> TO START/STOP FLOWCELL WASH.

This screen is also referred to as the “Home screen” of the analyzer. Select any
option by pressing any one of the alphanumeric keys (1-6) corresponding to the
desired option.
The options on the opening screen are described below:
1. RUNTEST: Different tests can be performed using this menu.

2. TEST PARAMTERS: This menu is to view, edit, save and print the
parameters including test name and it’s description.

User Manual(Ver 0.0 Jun 08) 27

 3. Q.C. REPORTS: This menu is to view and print daily & monthly QC data
for selected test.

4. MAINTENANCE: Maintenance mode is a self diagnostic mode and is mainly

used by the Service Personnel to check temperature, pump calibration,
printer test, default parameters downloading, checking readings of
PRE and LOG channels for every filter, offset storage, Filter gain calibration
and keypad check.

5. PATIENT REPORTS: Patient-wise reports of all chemistries run for a

particular sample (sorted by the date, I.D. No. or date and I.D. both).

6. SYSTEM SETUP: To set the laboratory information, system date, time and
the data output mode, Blank deduction.

C. SYSTEM SETUP

The system setup menu allows the user to set the system date, time and the data
output mode.

The “System Setup” screen is as follows:

*** SYSTEM SETUP ***

DATE: 22/06/07 TIME:10:02:05

PRESS KEY <1-6> TO SELECT DESIRED MENU

1 DATE 2 TIME
3 OUTPUT MODE 4 LAB INFORMATION
5 BLANK DEDUCTION

The numeric keys 1, 2, 3, 4 and 5 are used to set the date, time, data output mode,
laboratory information and blank deduction respectively.
Sections 1,2, 3, 4 and 5 cover each of the above options in detail.

1. SETTING THE DATE:

The analyzer incorporates a built-in calendar function, which is maintained by a
battery, and once set, the Date and Time will be printed every time the analyzer
prints result data on the printer.
Press numeric key ‘1’ and the following screen appears:

User Manual(Ver 0.0 Jun 08) 28

 *** SYSTEM SETUP:DATE ***
DATE: 22/06/07 TIME: 10:07:06

ENTER DATE IN A FORMAT DD/MM/YY

<fn>-SAVE DATE AND RETURN.
<PREV.>-QUIT WITHOUT SAVING.

The cursor is positioned on the DATE field on the SYSTEM SETUP:DATE screen.
Enter an appropriate data in the following format:

DAY : Enter a day from 01 to 31

MONTH : Enter a month from 01 to 12

YEAR : The last 2 digits of any year from 00 to 99

After appropriate entry is made, press the <fn> key to save date and return to
the System Setup screen or press < PREV. > to quit without saving and return to
the System Setup screen.

If the date is entered wrong, the user will be prompted with the message,
“INVALID DATE. PLEASE ENTER AGAIN.”

2. SETTING THE TIME:

Choose the option ‘2’ from the System Setup menu and SET TIME. The
display appears

*** SYSTEM SETUP: TIME ***

DATE: 22/06/07 TIME: 09:57:06

ENTER TIME AS PER 24 HOURS CLOCK.

<fn>-SAVE TIME AND RETURN.
<PREV.>-QUIT WITHOUT SAVING.

The cursor is positioned on the TIME field on the SYSTEM SETUP:TIME

screen. Enter an appropriate time in the format as stated below

HOUR: Enter an hour from 00 to 23

MINUTE: Enter minutes from 00 to 59

User Manual(Ver 0.0 Jun 08) 29

 SECONDS: Enter seconds from 00 to 59

Each entry is separated by a ‘ : ’ sign, which appears automatically after

the entry of the 2nd digit.

After appropriate entry is made, press the <fn> key to save and return to the
System Setup screen or press <PREV.> to quit without saving and go back to
the System Setup screen.
If the Time is entered wrong, the user will be prompted with the message,
“INVALID TIME. PLEASE ENTER AGAIN.”

3. SETTING THE DATA OUTPUT MODE:

Choose numeric key 3 on the system Setup menu to select the data
output mode

*** SYSTEM SETUP:DATA OUTPUT MODE ***

PRESS ARROW KEYS TO NAVIGATE
PRESS <YES/NO> TO SELECT OR DESELECT

(√) THERMAL PRINTER -> (√) PRINT KEY

(√) EXT.USB PRINTER -> ( ) PRINT KEY

Press <YES> or <NO> to select or deselect Thermal printer or

USB Printer for auto print options and when printout is opted after
pressing <PRINT> key.
Tick mark √ will be displayed in front of selected option & it will disappear
if any option deselected.

4. LAB INFORMATION:

LABORATORY INFORMATION

DR. ALLEN SMITH

ERBA DIAGNOSTICS LABORATORY,
FRIEDRICHSRING 4,
68161,MANNHEIM, GERMANY
PH.NO. + 49 621 1780960

The user can enter laboratory information, (25 characters each on 5 lines) with either the
external PC AT keyboard or the analyzer Keypad. This is stored in the memory.

User Manual(Ver 0.0 Jun 08) 30

Example of Using analyzer Keypad to Enter Lab information:
Each key can be used for entering three
alphabets in upper and lowercase. And
followed by the number seen on the key,

e.g. ‘A’, ‘B’, ‘C’, ’a’, ’b’, ’c’, ‘1’

TO

‘Y’ , ’Z’ , ’ ‘ , ’y’ , ’z’ , ’-‘ , ’9’

* ’ ( ) . 0
‘ ’,’ ’,’ ‘,‘ ‘,’ ’,’ ’,’ ’

5 Blank deduction

* SYSTEM SETUP:BLANK DEDUCTION OPTION *

PRESS <YES/NO> TO SELECT OR DESELECT

BLANK DEDUCTION : X

Press <YES> or <NO> to select or deselect. Tick mark <√> will be displayed in front
of selected option & <X> will be displayed in front of deselected option.

D. TEST PARAMETERS

The analyzer is preprogrammed for test codes. The test code for any chemistry
can be created, changed or viewed by the operator. A test code can have a
maximum of four characters which could be an abbreviation of the chemistry name
as per the convenience of the operator e.g. ALB, CRE, GLU etc. or alphanumeric
such as CO2 (all vacant positions are identified by an ‘ * * * * ‘ code).

To view, edit, save and print test parameters of a chemistry or to edit a test
parameters select TEST PARAMETERS from the MAIN MENU by pressing the
numeric key ‘2’.
Test Parameters menu is used to change the parameters including test name and
it’s description. The Test Page screen is displayed on selecting TEST
PARAMETERS:

User Manual(Ver 0.0 Jun 08) 31

 ***TEST PARAMETERS***
PAGE: 1
GLU CREA URE BUN CAO BIT
BID ALT AST ALP CHO TRIG
HDL AMY CAA PRO ALB URIC
PHO LDH GGT ACP CKN CKMB
**** **** **** **** **** ****

On pressing the <PRINT> Key all test displayed on test page will be printed on
Thermal printer. Last selected test is highlighted by default; use arrow keys to go to
different tests. Press< HELP> key to obtain help.

To view, edit, save & print test parameters of individual test select the test code as
described above & then press <ENTER>.

The display will show all the parameters screen of the selected test, with the
cursor at the mode field. The cursor can be shifted to the required position using
the arrow keys.
Following is an example of main parameters of ALB in the 1-Point mode.

ALB (Albumin ) <ENTER>-NEXT PARAMS

MODE : 1-POINT DELAY T : 5
FILTER1 : 630 READ T/NO: 0/0
FILTER2 : 000 NORM MIN : 3.2
RG. O.D. : 0 NORM MAX : 5.0
FACTOR : 0 TEMP : 37
STD.CONC : 3.6 UNIT : g/dl

Predefined values, for any of the selected parameter are available in the ‘Help
Menu Box’ which can be displayed by pressing <HELP>. The numbers in the
box correspond to the numeric key that can be used to select a particular value
for that parameter. For the other parameters the user can use the numeric keys
to enter the appropriate data. Press <HELP> to exit “Help Screen”.

After making the changes press <fn> to save the changes. Wrongly entered
parameters will not be accepted and the cursor will be positioned on the wrong
entry when <fn> is pressed. Press <HELP> to display help and make the
changes as suggested. Press < PREV > to return to previous screen. If <PREV>
is pressed before saving analyzer will prompt “SAVE PARAMS? Y/N”. Press
<YES> to save and quit or press <NO> to quit without saving.

EXAMPLE: When the cursor is at the parameter ‘MODE’, the Help Menu box
displays 10 different modes. If the numeric key 1 is pressed, 1- POINT MODE
will be selected.

User Manual(Ver 0.0 Jun 08) 32

 To set the DELAY T. to 5 use the numeric key 5.

By pressing < ENTER > again on this screen next page of parameters for the
selected test is displayed as below.

<ENTER>-PREVIOUS PARAMS
RX.DIR. : INC ASP.VOL: 500
RG.ABSLIM: 0 C1 MEAN: 0
RX.ABSLIM: 0 C1 2SD : 0
LIN.LIM : 6.0 C2 MEAN: 0
SAMP.VOL : 5 C2 2SD : 0
R1/R2VOL : 500/0

Press <HELP> to display help for every selected parameter. After modifying
the parameter values press <fn> to save or <PREV> to quit without saving.

E. PARAMETER DEFINITIONS AND VALUES

MODE : Ten modes of operation are available and these can be selected
using the numerical keys 0 through 9.

Key ‘0’ - ABS - For absorbance mode (gives only ABS).

Key ‘1’ - 1 – POINT - For linear end-point chemistries.
Key ‘2’ - 2 - POINT - For fixed time chemistries.
Key ‘3’ - RATE A - For kinetic chemistries.
Key ‘4’ - 1_PT_NL - For 1-Point non-linear chemistries.
Key ‘5’ - 2_PT_NL - For 2-Point non-linear chemistries.
Key ‘6’ - RATE_NL - For nonlinear kinetic chemistries.
Key ‘7’ – COAGULATION - For Coagulation
Key ‘8’ - SAMP_BK - For Sample Blank chemistries
Key ‘9’- SAMP_BK_NL - For nonlinear Sample Blank chemistries

FILTER 1: It is the primary filter at which measurements are made. The

available wavelengths are: 340, 405, 505, 546, 578 & 630nm. Six filter
wavelengths are available which can be chosen from the Help Menu Box on the
screen, using the numeric keys 1 through 6.

Key ‘1’ - 340nm

Key ‘2’ - 405nm
Key 3 - 505nm
Key 4 - 546nm
Key ‘5 - 578nm
Key ‘6’ - 630nm

User Manual(Ver 0.0 Jun 08) 33

 FILTER 2: Choice of this filter is optional and may be used to perform
bichromatic measurements in absorbance or concentration modes.
Set the value to 0 for monochromatic readings. Six filter
wavelengths are available which can be chosen from the ‘Help
Menu’ box using the numeric keys 0 through 6.
Key ‘0’ - 000nm
Key ‘1’ - 340nm
Key ‘2’ - 405nm
Key 3 - 505nm
Key ‘4 - 546nm
Key 5 - 578nm
Key ‘6’ - 630nm

RG. OD.OR D RG. OD. OR D RG OD./m:

For 1-Point linear, 1 Point Nonlinear & sample blank analysis
mode RG.O.D. field will be displayed The RG O.D.(Reagent
Optical density) is the reagent blank absorbance which is stored
after running reagent blank.
For 2-point linear and 2-point nonlinear mode D.RG.OD field will
be displayed. The D RG O.D.(Delta Reagent Optical density) is
the Difference of Absorbance readings between two Measuring
points for reagent blank.
For Rate A, and Rate A Nonlinear. D RG OD/m (Delta Reagent
Optical density per minute) field will be displayed, which is the
Rate of change of absorbance for reagent blank. The D RG O.D
and D RG O.D/m is also known as self-reactivity of reagent. This
field is not editable, only zero can be entered.

FACTOR : It is a value ranging from -99999 to 999999 which is used for

calculation of results after calibration factor is automatically
calculated & stored by the instrument. User can edit or feed factor
manually also, in this field decimal key is functional.

STD_CONC : It is a value ranging from 0 to 99999 according to

concentration of the standard used in the calibration of the
test.

The Standard value can be set to 0 when a predetermined or

NOTE :
calculated factor is used. The decimal point can be inserted in the
figure using ‘.’ Key For example 3.0, 30.0

NOR. MIN. : Any value ranging from 0 to 99999 may be fed to define the
minimum value found in normal population for the analysis.
During the printing of the sample results a (L) sign is printed

User Manual(Ver 0.0 Jun 08) 34

 beside the sample number if the result is below the NOR.
MIN value, thus highlighting an abnormally low result.

NOR. MAX. : Any value ranging from 0 to 99999 may be fed to define the
maximum value found in normal population for the analysis.
During the printing of the sample results a (H) sign is printed
beside the sample number if the result is above the NOR. MAX
value, thus highlighting an abnormally high result.

The decimal point can be inserted in the value using “.”Key in

NOTE : both these parameters if required.

TEMP. : It is for selecting the cuvette temperature. Four temperature

choices are available which can be chosen from the Help
Menu Box using the numeric keys 0 through 3.
Key ‘0’ - OFF
Key ‘1’ - 25º C
Key ‘2’ - 30º C
Key ‘3’ - 37º C

The maximum time required to attain the desired temperature is

less than 2 minutes (from switched ‘OFF’ position). However, a
pre-warmed solution which has already attained the desired
temperature, takes a much shorter time.

DELAY T. : It is the lag time or delay time (in seconds), for the reaction to reach
equilibrium. (Please refer to the reagent manufacturers
specification). In case of End-Point test, it is the time (in seconds)
required for the solution to stabilize in the Flowcell/Cuvette. The
programmed delay time appears as incubation time for any
analysis (automatically performed).
A range from 5 to 999 seconds is available.

READ T/NO.: It is the time interval (in seconds) between two readings in 2-Point
and Rate A modes and can be programmed from 5 to 999
seconds. It is described by Total READ Time & calculated by
multiplication of READ Time Interval & Number of readings (Total
READ Time = READ Time Interval * Number of Readings).
Eg: if the User enters READ T =5 and Read NO =1, Then Total
READ Time = 5*1=5Sec.

RX. DIR : This parameter is used for flagging and calculation of sample
concentration.
Key ‘0’ - DEC
Key ‘1’ - INC

User Manual(Ver 0.0 Jun 08) 35

 RG. ABSLIM: It is working range of reagent blanking. It is a value ranging from 0
to 2.5 It is a value defining the deterioration limit of the reagent OR
it is working range of reagent blank.
If the reaction direction is increasing, it is higher limit.
If the reaction direction is decreasing, it lower limit.
During the test performance (1) For decreasing reaction if the
reagent absorbance is lower than the value that has been set, the
analyser gives a warning of “CRITICAL REAGENT ABS” along
with the reagent blank result. A flag critical RGTABS is printed.
(2) For increasing reaction if the reagent absorbance is higher than
the value that has been set, the analyser gives a warning of
“CRITICAL REAGENT ABS” along with the reagent blank result. A
flag critical RGTABS is printed.

RX. ABSLIM: It is a value ranging from 0 to 2.5 indicating the minimum or

maximum absorbance limit.

If the reaction direction is increasing, it is higher limit.

If the reaction direction is decreasing, it lower limit.

During the test performance (1) For decreasing reaction if the

absorbance of reaction mixture during read time is lower than the
value that has been set, the analyser gives a warning of “RX
ABSORBANCE UNDER”. (2) For increasing reaction if the
absorbance of reaction mixture during read time is higher than the
value that has been set, the analyser gives a warning of “RX
ABSORBANCE OVER” along with the result.

LIN. LIM. : It is linearity of reagent kit. It is to be entered in terms of

concentration and it ranges from 0 to 99999.This parameter is
useful to reveal a Hyperactive Sample. The photometer performs
the measurement and prints “HYPERACTIVE SAMPLE” along
with test result if the sample crosses the value that has been set
and this would be an indication that the sample has to be diluted
and reassayed.

UNIT : Here, with the help of the numeric keys ‘1’ to ‘9’ keys the operator
is able to select the appropriate unit from 3 pages of Help menu, for
expressing the test results. The pages of help menu can be
accessed using, <YES>, <0> and <CALIB> keys. 27 different units
are available through numeric keys of which one unit can be
selected depending on the chemistry.

1> mg/dl 2> U/l 3> IU/ml

4> mEq/l 5> g/l 6> g/dl
7> % 8> mU/l 9> mU/ml

User Manual(Ver 0.0 Jun 08) 36

 .>1PAGE 0>2PAGE CALIB>3PAGE

1> ng/ml 2>ug/dl 3>mg/lt

4> ng/l 5>mg/l 6>ug/l
7> umol/l 8>mmol/l 9>ug/ml
.>1PAGE 0>2PAGE CALIB>3PAGE

1> uIU/ml 2> mmol/ml 3>umol/ml

4> nmol/l 5> pmol/l 6> mIU/l
7> 8> INR 9> SEC
.>1PAGE 0>2PAGE CALIB>3PAGE

NOTE : Please check the units modified in the kit insert.

SAMPLE VOL (µl) : This volume is displayed in the RUNTEST screen and
helps the operator in pipetting correct volume of
Sample.

R1/R2 VOL (µl) : This volume is displayed in the RUNTEST Mode and
helps the operator in pipetting correct volume of
Reagent.

ASP VOLUME (µl) : It is a value ranging between 350 to 999 and

represents the volume of the solution to be aspirated
into the Flow cell.
With the Flow cell capacity bring 33 µl, a min. 350µl
volume is recommended to eliminate errors due to
carry over.

C1 MEAN : It is the target value of the control 1 ranging from 0 to

99999 for a particular test.
C1 2SD : This is the preset 2SD range of the control 1. It ranges
from 0 to 9999.

C2 MEAN : It is the target value of the control 2 ranging from 0 to

99999 for a particular test.

C2 2SD : This is the preset 2SD range of the control 2. It ranges

from 0 to 9999.

NOTE : In case any of these parameters is not entered or are incorrect

the analyzer will not proceed with the measurement, instead it
will be back to the parameter page and the cursor will blink in
front of that parameter.

User Manual(Ver 0.0 Jun 08) 37

 F. CHANGING THE CHEMISTRY NAME AND DESCRIPTION

In Test Parameter page, press <↑> Key(Up arrow key )when the cursor is at mode
parameter to position the cursor on the test name and type the required name and
description and press <fn> to save.

G. MAINTENANCE MODE

Press numeric key <4> in the Home screen and the following screen is displayed:

*** MAINTENANCE *** Ver:2008.01

FLOWCELL TEMPERATURE = 37.0

0 OFF 1 25°C 2 30°C 3 37°C

To set the temperature of the flowcell press any of the numeric keys <0-3> and
corresponding temperature is attained in the flowcell.
Press < → > key to display the next page.

*** MAINTENANCE *** Ver:2008.01

PUMP CALIBRATION = 2000

PERFORM WASH WITH 3ml DI WATER

a) PUMP CALIBRATION: In this menu it is required to calibrate the Peristaltic pump

by aspirating 1000µL of DI water.
Note: Perform WASH with 3ml DI Water to fill the tube up to peristaltic pump
before proceeding for Pump Calibration.
1. Take 1000 µL of distilled water in test tube.
2. Press ASP switch to aspirate distilled water. Aspirate till the last drop of water is
aspirated and again press ASP switch to stop aspiration.
3. The count will be displayed on the screen. Now the peristaltic pump is
calibrated to aspirate any volume from 350 µl up to 999 µl.

b) LOAD DEFAULT PARAMETERS: Press <fn> to download default Test

parameters from the memory.

User Manual(Ver 0.0 Jun 08) 38

 *** MAINTENANCE *** Ver:2008.01
<fn> - LOAD DEFAULT PARAMETERS.

Press <→ > key to go to the next page or < ← > to go back to the previous page.

c) FILTER CHECK MENU:

*** MAINTENANCE *** Ver:2008.01
FILTER PRE CHANNEL LOG CHANNEL
340 201513 0.042

Press numeric keys <1> to <6> get PRE CHANNEL and LOG CHANNEL readings
for 6 filters.
Press < → > key to display the next page.

d) THERMAL PRINTER TEST MENU: Test Print for thermal printer.

*** MAINTENANCE *** Ver:2008.01

PRESS <PRINT> TO TEST PRINTER

Press < → > key to display the next page.

e)KEYPAD CHECK MENU: Test all the 25 keys in this menu.

User Manual(Ver 0.0 Jun 08) 39

 This page is intentionally kept blank

User Manual(Ver 0.0 Jun 08) 40

 CHAPTER VI
MODES OF OPERATION

A. ABSORBANCE MODE
In this mode, the analyzer can measure the absorbance or the optical density of
the reaction mixture. The operational steps to perform a test in this mode are as
follows

1. Choose RUN TEST option from the opening screen. Press <ENTER> to select a
test with Absorbance mode.

2. The RUNTEST screen with the parameters that are necessary for the analyzer to
operate in this mode are displayed on the screen.

3. Aspirate distilled water when instrument asks Aspirate Water.

4. The absorbance on the display will be set to “0”. Thus instrument will auto zero
itself.

5. The samples I.D. is auto-generated but if the user wants to generate a new number
then type any 6 digit Alpha numerical code using any of the keys. After new sample
ID is entered message “Press <ENTER> to confirm ID” appears. Once <Enter>
key is pressed the next sample can be aspirated.

6. Aspirate the test solution to determine its absorbance. The display will directly give
the absorbance of the sample. An automatic printout is obtained if “Thermal Printer”
option is checked in the system setup or else press < PRINT > to get the print out.

7. Press <READ> key if the absorbance is to be measured using Polystyrene cuvette.

For continuous read mode, Press <fn> Key, the following screen is displayed. Now
Type the duration (in minutes) for which the readings are to be taken. Every ten
second one reading is displayed and printed.
ALB (ABS ) T: 37.0°C I.D.: 000001
FILTER : 630/000
ABS: 0.020
DURATION: 10 Minutes

ASPIRATE SAMPLE

8. After all readings are taken remove the Polystyrene cuvette, and press <RESET>
key to exit this screen.

9. When the display changes to the “Home screen” wash the flowcell, using the
“fn/WASH” Key.

User Manual(Ver 0.0 Jun 08) 41

 NOTE: In Absorbance mode the unit automatically gets converted to ABS
hence if you have mistakenly selected absorbance mode for any test
parameter then on changing it to some other mode please select
appropriate unit before saving the test.

B. 1- POINT LINEAR MODE

In this mode, the analyzer displays both, absorbance as well as concentration

readings on the screen. The concentration value is obtained after multiplying the
absorbance value with a factor that is obtained during calibration.

1. The operational steps are as follows:

2. Choose RUN TEST option from the opening screen. Press <ENTER> to select a
test with 1-Point mode (linear) .

3. The RUN TEST screen will now display with the parameters that are
necessary for the analyzer to operate in this mode are displayed on the
screen.

ALB (1-POINT) T: 37.0°C I.D.:

FILTER : 630/000
RG. O.D.
STD.CONC
FACTOR
:
:
:
0
3.6
0
ABS: 0.000
SAMP VOL : 3
R1/R2 VL : 500/0 ASPAAA WATER
ASPIRATE
DELAY T : 5

4. Aspirate distilled water when “ASPIRATE WATER” is displayed on the

screen.

5. The instrument will auto zero itself. The displayed ‘0’ absorbance of water
blanking will establish baseline to calculate absorbance of reagent blank,
standard, sample etc.

6. Aspirate the Reagent Blank when the analyzer displays “ASPIRATE

REAGENT BLANK” & “PRESS NO TO SKIP” alternately. Press <NO> to
skip reagent blank. If <NO> is pressed while display is prompting
<ASPIRATE REAGENT BLANK> & <PRESS NO TO SKIP> alternately,
then previously stored reagent blank OD will be used for calculation of factor.

User Manual(Ver 0.0 Jun 08) 42

 7. Aspirate standard solution (RGT + STD), when the analyzer displays
“ASPIRATE STANDARD” & “PRESS NO TO SKIP” or press <NO> to skip
standard. If the Standard concentration and factor is not zero, new factor is
calculated. After aspiration of standard solution the analyzer displays the
absorbance and asks whether to store the new value for Factor, as shown in
figure below. Press <YES> to store the values or < NO> to retain the old
values.

GLU (1-POINT) T:37.0°C I.D.:

FILTER : 505/000
RG. O.D. : 0.01
STD.CONC : 100
FACTOR
SAM VOL
: 352
: 3
ABS: 0.294
R1/R2 VL : 500/0 NEW FACTOR: 340.1
DELAY T : 5
SAVE NEW VALUES?(Y/N)

8. When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN->C2”

alternately. Go for controls by pressing UP / DOWN key for C1/C2 .Now “C1”
is displayed in place of sample ID. You may press <NO> to skip Controls and
the screen once again display “ASPIRATE SAMPLE” & “UP->C1 DOWN-
>C2” alternately. But if you press <DOWN> Key then next command
displayed is “ASPIRATE CONTROL 2” and in place of Sample I.D. ,“C2” is
displayed on the screen. You may press <NO> to skip C2. The results of
control(s) thus analyzed will be stored in memory for Levy Jenning’s graph.

9. When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN->C2”

alternately, one can enter appropriate patient ID and then Aspirate reaction
mixture (RGT + SMP). The analyzer will automatically start incubation
countdown (entered as Delay time in parameters). At the end of delay time
final absorbance and result will displayed on screen.

10. The screen will now display updated patient ID e.g. If Patient ID for the
current chemistry run was AN123 then after running the sample instrument
will automatically display AN124 as next ID .IF next Patient ID is different
then enter new patient ID and follow similar procedure to test sample. After all
readings are taken, press the < PREV> key till you return to the “Home
screen “.

11. To wash the flowcell with distilled water, hold tube containing distilled
water under the aspiration tube and press <fn> to start the wash action and
after proper wash press <fn> Key to stop wash.

User Manual(Ver 0.0 Jun 08) 43

C. 2- POINT LINEAR MODE

The Two Point mode is a Kinetic analysis performed at a fixed interval. The
result is obtained by multiplying the difference between the initial and final
absorbance values with the respective factor programmed or obtained after
calibration.

1 Choose RUN TEST option from the opening screen. Press <ENTER> to
select a test with 2-Point Linear mode.

2 The RUN TEST screen will now display with the parameters that are
necessary for the analyzer to operate in this mode are displayed on the
screen.

3 Aspirate Distilled Water when “ASPIRATE WATER” is displayed on the

screen.

4 The absorbance on the display will be set to “0”. This absorbance is

subtracted from the sample absorbance, reagent absorbance and
standard absorbance.

5 Aspirate the Reagent Blank when the analyzer displays “ASPIRATE

REAGENT BLANK” & “PRESS NO TO SKIP” alternately. Press <NO>
to skip reagent blank if required or else aspirate reagent blank and wait for
a few seconds. The analyzer will automatically start incubation countdown
(entered as Delay time in parameters) followed by the Rate time
countdown for “1” reading. At the end of analysis is signalled by an
acoustic beep. The delta ABS of the Reagent Blank is calculated.

CRE (2-POINT) T:37.0°C I.D.:

FILTER : 505/000

0.006
D RG.O.D. : 0.006
STD.CONC : 2 Delta:
FACTOR : 0 ABS
SAMP VOL : 30
R1/R2 VL : 500/0
D/R TIME : 20/60 ASPIRATE STANDARD

6 Aspirate Standard solution (RGT + STD.) when the screen displays

“ASPIRATE STANDARD” & “PRESS NO TO SKIP” alternately or press
<NO> to skip. On aspiration of standard solution the analyzer will
automatically start incubation countdown (entered as Delay time in
parameters) followed by the Read time countdown. The end of analysis is
signalled by an acoustic beep. The delta ABS of the standard will be
displayed along with new calculated factor, if the standard concentration
and factor is not fed as zero. The analyzer asks whether to store the new
value for factor and Delta Reagent ABS. Press YES to store the values or

User Manual(Ver 0.0 Jun 08) 44

 NO to retain the old values. On storing , for all subsequent readings, this
delta ABS. of reagent is subtracted to obtain a final delta ABS. of reaction
mixture. The graphical representation of the reaction can be displayed on
the screen by pressing <ENTER>. The printout of result and graph can be
obtained by pressing the “PRINT” key at respective screens.

7 When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN-

>C2” alternately. Go for controls by pressing UP / DOWN key for C1/C2
.Now “C1” is displayed in place of sample ID. You may press <NO> to
skip Controls and the screen once again display “ASPIRATE SAMPLE”
& “UP->C1 DOWN->C2” alternately. But if you press <DOWN> Key then
next command displayed is “ASPIRATE CONTROL 2” and in place of
Sample I.D. ,“C2” is displayed on the screen. You may press <NO> to
skip C2. The results of control(s) thus analyzed will be stored in memory
for Levy Jenning’s graph.

8 When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN-

>C2” alternately, one can enter appropriate patient ID and then Aspirate
reaction mixture (RGT + SMP). The analyzer will automatically start
incubation countdown (entered as Delay time in parameters) followed by
the Read time countdown. The end of analysis is signalled by an acoustic
beep. The delta ABS of the reaction mixture will be displayed along with
the concentration of the sample, calculated using the stored factor.

9 After analyzing all the samples, press <PREV> key to exit the menu.

10 When the display changes to the “Home screen” wash the flowcell, using
the “fn” Key. (Follow the instructions on the display.)

D. RATE A LINEAR MODE :

Most Enzyme / Kinetic chemistries are performed using this mode.

The operational steps to perform Enzyme / Kinetic test are as follows:

1. Choose RUN TEST option from the opening screen. Press <ENTER>
to select test with Rate A (linear).

2. The RUN TEST screen will now display with the parameters that are
necessary for the analyzer to operate in this mode are displayed on the
screen.

3. The analyzer displays “ASPIRATE WATER”, aspirate distilled water. The

analyzer automatically zero’s the O.D.

4 Aspirate the Reagent Blank when the analyzer displays “ASPIRATE

REAGENT BLANK” & “PRESS NO TO SKIP” alternately and wait for a

User Manual(Ver 0.0 Jun 08) 45

 few seconds. The analyzer will automatically start incubation countdown
(entered as delay time in parameters) followed by the Read time
countdown. The end of the analysis is signalled by an acoustic beep. The
delta ABS per minute of the Reagent Blank is automatically stored in the
memory of the analyzer and for all subsequent readings, this delta ABS
per minute is subtracted to obtain a final delta ABS per minute of reaction
mixture. When the analyzer displays “ASPIRATE REAGENT BLANK” &
“PRESS NO TO SKIP” alternately then you may press “NO” to skip
reagent blank.

5. The screen displays “ASPIRATE STANDARD” & “PRESS NO TO SKIP”

alternately, if you have programmed standard concentration as a non zero
value in test parameters. In this case aspirate standard solution (RGT +
STD.). However In case standard concentration value is fed as “0” &
calibration factor as any valid non zero value, then “ASPIRATE
STANDARD” prompt will not be given and directly ASPIRATE SAMPLE
& C1->UP, C2->DOWN messages will be displayed alternately. On
aspirating the standard for calibration, the analyzer will automatically start
incubation countdown (entered as delay time in parameters) followed by
the Read time countdown for Total Read Time (in secs). The display
continuously shows the change in ABS as the reaction proceeds. The
countdown shows the time lapsed since the start of the reaction.

The end of analysis is signalled by an acoustic beep. The delta ABS per
minute of the standard will be displayed along with new calculated factor,
if the standard concentration and factor is not fed as zero. The analyzer
asks whether to store the new value for factor and Delta Reagent ABS per
minute. Press YES to store the values or NO to retain the old values. On
storing, for all subsequent readings, if the Blank Deduction option is
selected, the delta ABS per minute of reagent is subtracted to obtain a
final delta ABS per minute of reaction mixture. The graphical
representation of the reaction can be displayed on the screen by pressing
<ENTER>. The printout of result and graph can be obtained by pressing
the <PRINT> key at respective screens.

6 When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN-

>C2” alternately. Go for controls by pressing UP / DOWN key for C1/C2
.Now “C1” is displayed in place of sample ID. You may press <NO> to
skip Controls and the screen once again display “ASPIRATE SAMPLE”
& “UP->C1 DOWN->C2” alternately. But if you press <DOWN> Key then
next command displayed is “ASPIRATE CONTROL 2” and in place of
Sample I.D. ,“C2” is displayed on the screen. You may press <NO> to
skip C2. The results of control(s) thus analyzed will be stored in memory
for Levy Jenning’s graph.

7 When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN-

>C2” alternately, one can enter appropriate patient ID and then Aspirate

User Manual(Ver 0.0 Jun 08) 46

 reaction mixture (RGT + SMP). The analyzer will automatically start
incubation countdown (fed as Delay time in parameters) followed by the
Read time countdown. The display continuously shows the change in ABS
as the reaction proceeds. The countdown shows the time lapsed since the
start of the reaction. The end of the analysis is signalled by an acoustic
beep and the result and the graphical representation of the reaction is
displayed on the screen.

8 After analyzing all the samples, press the < RESET> key to exit this screen.

9 When the display changes to the “Home screen” wash the flowcell,
using the “fn” Key.

The graphical representation is as shown below:

Rate A (GPT)

1.7884

1.7122

1.6363

Y Axis = ABSORBANCE
X Axis : 1 Unit =10.00 sec

E. 1-POINT NON-LINEAR MODE

There are some chemistries which are performed using methods where the
sample absorbances are not directly proportional to the concentration. In such
cases the analyzer is capable of plotting multi-standard non-linear calibration
curves. These curves are stored in the memory of the analyzer and used directly
to interpolate the sample assay results.

The operational steps are as follows when calibration has to be performed:

1. Select RUNTEST from the Home screen. Select the required test from
the Analysis code screen where 1-Point Non-linear mode is selected and
press <ENTER>.
The following screen is displayed:
CRP (1-PT_NL)

POINT TO POINT SPLINE 3

<1> FOR CALIBRATION
<2> FOR GRAPH
<3> FOR SAMPLE RUN.
(<fn>-SELECT METHOD)

User Manual(Ver 0.0 Jun 08) 47

 2. Press < fn > to toggle between POINT TO POINT and SPLINE methods.
Press < 1 > FOR CALIBRATION.
Press < 2 > FOR GRAPH.
Press < 3 > FOR SAMPLE RUN.

NOTE : Non-linear chemistries can be performed by directly entering the

absorbance values of the standards in the absorbance column of the
calibration table. Press the “PREV” key to go back to the previous
screen and then the numeric key “3” for sample run.

3. To begin the procedure for curve calibration, press the numeric key < 1 >.
The calibration table seen on the display is as follows:

CRP (1-PT_NL) 22/06/07 12:03:04

CONC. ABS. CONC. ABS.

STD1 0 0 STD4 40 0
STD2 20 0 STD5 50 0
STD3 30 0 STD6 60 0
NOTE: STD1 to be treated as BLANK
4. Using the vertical cursors Ð Ï and the numeric keys enter the concentration
of the standards to be run. A minimum of 3 and a maximum of 6 standards
can be used. If the number of standards is less than six, zero values must be
entered against the corresponding standard number. Press <fn> key to save
calibration data. Press < CALIB > key to measure the actual absorbance of
standards and reagent blank.

5. On pressing < CALIB > key the following screen is displayed

CRP (1-PT_NL) T: 37.0°C I.D.:
FILTER : 340/000
SAMP VOL : 5 ABS:
R1/R2 VL: 500/0
DELAY T : 5
ASPIRATE WATER
a. When the analyzers displays “ASPIRATE WATER”, then Aspirate
distilled water and wait for a few seconds. (The Analyzer automatically
zero’s the ABS)

b. In the calibration table, the standards for which the concentration is

entered, only those standards can be run. Aspirate the standard
when the analyzer displays “ASPIRATE STANDARD # ” &

User Manual(Ver 0.0 Jun 08) 48

 “PRESS NO TO SKIP” & wait for the absorbance reading to
stabilize. (# indicates the number of the standard)

c. Repeat step. ‘d’ for all standards in sequential order.

d. When all the standards (for which the concentrations are entered)
are run, the screen for calibration table is automatically displayed
with updated absorbance values.

e. Press the “<PREV>” key to return to the Non-Linear test screen.

f. Press the numeric key < 2 > to verify the Display of the graph .

The statistical procedure used to elaborate the curve is based on the

method of cubic Spline interpolation or Point-to-Point method whichever is
selected.

An example of an interpolation of a non- linear curve

TEST:CRP X AXIS:1 Unit=1.000 mg/dl

3.0000

2.0000

1.0000

g. To get a printout of the curve press the “PRINT” key.

This is the end of the calibration procedure. The curve obtained is
stored in the memory of the analyzer till recalibration is performed.

j. To run a sample, go back to the Non Linear Test Screen and press the
numeric key < 3 >.

k. Aspirate water when “ASPIRATE WATER” is displayed on the

screen.

l. When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN-

>C2” alternately. Go for controls by pressing UP / DOWN key for
C1/C2 .Now “C1” is displayed in place of sample ID. You may press
<NO> to skip Controls and the screen once again display “ASPIRATE
SAMPLE” & “UP->C1 DOWN->C2” alternately. But if you press

User Manual(Ver 0.0 Jun 08) 49

 <DOWN> Key then next command displayed is “ASPIRATE
CONTROL 2” and in place of Sample I.D. ,“C2” is displayed on the
screen. You may press <NO> to skip C2. The results of control(s) thus
analyzed will be stored in memory for Levy Jenning’s graph.

m. When the screen displays “ASPIRATE SAMPLE” & “UP->C1 DOWN-

>C2” alternately, one can enter appropriate patient ID and then
Aspirate reaction mixture (RGT + SMP). The analyzer will
automatically start incubation countdown (entered as Delay time in
parameters). At the end of delay time the analyzer will give the results
interpolated directly from the previously plotted graph using the
absorbance read by the photometer.

F. 2-POINT NON LINEAR MODE

The operational steps are as follows when calibration has to be performed:
1. Select RUN TEST from the “Home screen”. Select the required
test from the Analysis code screen where 2-Point Non-linear mode
is selected and press < ENTER >.
APOA (2-PT_NL)
POINT TO POINT SPLINE 3
<1> FOR CALIBRATION
<2> FOR GRAPH
<3> FOR SAMPLE RUN.
(<fn>-SELECT METHOD)

2. Press < fn > to toggle between POINT TO POINT and SPLINE

methods.
Press < 1 > FOR CALIBRATION.
Press < 2 > FOR GRAPH.
Press < 3 > FOR SAMPLE RUN.

3. To begin the procedure for curve calibration, press the numeric

key < 1 >. The calibration table seen on the display is as follows:
APOA (2-PT_NL) 22/06/07 12:03:04
CONC. D ABS. CONC. D ABS.

STD1 0 0 STD4 121 0

STD2 25 0 STD5 0 0
STD3 66 0 STD6 0 0
NOTE: STD1 to be treated as BLANK
4. Using the vertical cursors Ð Ï and the numeric keys enter the
concentration of the standards to be run. A minimum of 3 and a
maximum of 6 standards can be used. If the number of standards is
less than six, zero values must be entered against the corresponding

User Manual(Ver 0.0 Jun 08) 50

 standard number. Press < CALIB > key to measure the actual
absorbance and concentration of the reagent and standards.

5. On pressing < CALIB > key the following screen is displayed:

APOA (2_PT_NL) T: 37.0°C I.D.:

FILTER : 340/000
SAMP VOL : 5 ABS:
R1/R2 VL: 450/40
DELAY T : 5
ASPIRATE WATER

6. Aspirate distilled water when the analyzer displays “ASPIRATE

WATER”. The analyzer automatically zero’s the ABS.

7. Aspirate the first Standard solution when the screen displays

“ASPIRATE STANDARD 1” & “PRESS NO TO SKIP”. The analyzer
will automatically start incubation countdown (entered as Delay time in
parameters) followed by the Rate time countdown for “1” reading and
the delta ABS. is displayed on the screen.

8. Repeat step 7 for all standards in sequential order.

9. After all the standards have been aspirated the display returns to the
Calibration Table screen and displays the updated values. Press the
“PREV” key to return to the Non-Linear test screen.

10. Press the numeric key < 2 > key to verify the interpolation curve
display of the graph will be seen on the screen. The statistical
procedure used to elaborate the curve is based on the method of cubic
spline interpolation or Point-to-Point method, whichever is selected. To
get a printout of the curve press the “PRINT” key. This is the end of the
calibration procedure. The curve obtained is stored in the memory of
the analyzer till recalibration is performed.

11. To run a sample, go back to the Non Linear Test Screen and press
the numeric key < 3 >.

12. Aspirate water when “ASPIRATE WATER” is displayed on the

screen.

13. When the screen displays “ASPIRATE SAMPLE” & “UP->C1

DOWN->C2” alternately. Go for controls by pressing UP / DOWN
key for C1/C2 .Now “C1” is displayed in place of sample ID. You
may press <NO> to skip Controls and the screen once again

User Manual(Ver 0.0 Jun 08) 51

 display “ASPIRATE SAMPLE” & “UP->C1 DOWN->C2”
alternately. But if you press <DOWN> Key then next command
displayed is “ASPIRATE CONTROL 2” and in place of Sample
I.D. ,“C2” is displayed on the screen. You may press <NO> to skip
C2. The results of control(s) thus analyzed will be stored in memory
for Levy Jenning’s graph.

14. When the screen displays “ASPIRATE SAMPLE” & “UP->C1

DOWN->C2” alternately, one can enter appropriate patient ID and
then Aspirate reaction mixture (RGT + SMP). The analyzer will
automatically start incubation countdown (entered as Delay time in
parameters). At the end of delay time the analyzer will give the
results interpolated directly from the previously plotted graph using
the delta absorbance read by the photometer.

G. RATE A NON LINEAR MODE

The operational steps are as follows when calibration has to be performed:
1. Select RUN TEST from the Home screen. Select the required test
from the Analysis code screen where Rate A Non-linear mode is
selected and press < ENTER >.

2. Press < fn > to toggle between POINT TO POINT and SPLINE

methods.
Press < 1 > FOR CALIBRATION.
Press < 2 > FOR GRAPH.
Press < 3 > FOR SAMPLE RUN.

3. To begin the procedure for curve calibration, press the numeric

key < 1 >. The calibration table seen on the display is as follows:

4. Using the vertical cursors Ð Ï and the numeric keys enter the
concentration of the standards to be run. A minimum of 3 and a
maximum of 6 standards can be used. If the number of standards
is less than six, zero values must be entered against the
corresponding standard number. Press <fn> key to save calibration
data. Press < CALIB > key to measure the actual absorbance and
concentration of the reagent and standards.

5. Aspirate distilled water when the analyzer displays “ASPIRATE

WATER”. The analyzer automatically zero’s the ABS.

NOTE : The Rate A Non-linear mode can be performed by directly entering

the delta absorbance values of the standards in the absorbance
column of the calibration table. Press < PREV > to go back to the
previous screen and then press the numeric key < 3 > for sample
run.

User Manual(Ver 0.0 Jun 08) 52

 6. Aspirate the first Standard solution when the screen displays
“ASPIRATE STANDARD 1” & “PRESS NO TO SKIP”. The analyzer
will automatically start incubation countdown (entered as Delay time in
parameters) followed by the Rate time countdown for “1” reading and
the delta ABS. is displayed on the screen.

7. Repeat step for all standards in sequential order.

8. After all the standards have been aspirated the display returns to the
Calibration Table screen and displays the updated values. Press the
“<PREV>” key to return to the Non-Linear test screen.

9. Press the numeric key < 2 > key to verify the interpolation curve
display of the graph will be seen on the screen. The statistical
procedure used to elaborate the curve is based on the method of
least squared, cubic Spline interpolation or Point-to-Point method,
whichever is selected. To get a printout of the curve press the
“<PRINT>” key. This is the end of the calibration procedure. The
curve obtained is stored in the memory of the analyzer till
recalibration is performed.

10. To run a sample, go back to the Non Linear Test Screen and press
the numeric key < 3 >.

11. Aspirate water when “ASPIRATE WATER” is displayed on the

screen.

12. When the screen displays “ASPIRATE SAMPLE” & “UP->C1

DOWN->C2” alternately. Go for controls by pressing UP / DOWN
key for C1/C2 .Now “C1” is displayed in place of sample ID. You
may press <NO> to skip Controls and the screen once again
display “ASPIRATE SAMPLE” & “UP->C1 DOWN->C2”
alternately. But if you press <DOWN> Key then next command
displayed is “ASPIRATE CONTROL 2” and in place of Sample
I.D. ,“C2” is displayed on the screen. You may press <NO> to skip
C2. The results of control(s) thus analyzed will be stored in memory
for Levy Jenning’s graph.

13. When the screen displays “ASPIRATE SAMPLE” & “UP->C1

DOWN->C2” alternately, one can enter appropriate patient ID and
then Aspirate reaction mixture (RGT + SMP). The analyzer will
automatically start incubation countdown (entered as Delay time in
parameters). At the end of delay time the analyzer will give the
results interpolated directly from the previously plotted graph using
the delta absorbance read by the photometer. If in the system
setup thermal printer is activated then the result will be printed out
automatically, otherwise user has to press < PRINT > key.

User Manual(Ver 0.0 Jun 08) 53

H. COAGULATION MODE

For performing coagulation select tests like Prothrombin Time (PT) or Partial
Thromboplastin Time (PTT).
The screen will appear as follows.
PT (COAG.) T:37.0°C I.D.: 000001
FILTER : 505/000
STD.CONC : 13
FACTOR : 1 PLACE THE TUBE HOLDER
SAMP VOL : 100 ADD SAMPLE IN A TUBE.
R1/R2 VL : 200/0 PUT IT IN TUBE
D/R TIME : 180/0 HOLDER<FN>INCUBATION

1. User should replace the flow cell with specially provided adapter
and use the glass tubes (6.0 mm light path)

2. Add desired sample volume in the tube.

3. Press <fn> for incubation. Analyzer will start incubation countdown

entered as delay time in parameters.

4. In one reagent chemistry, READ TIME will be set to 0 where as in

two reagent chemistry, READ TIME field should have some value.

After the incubation is over the screen will appear as follows.

PT (COAG.) T:37.0°C I.D.: 000001
FILTER : 505/000
STD.CONC : 13
FACTOR : 1 ADD REAGENT IN A TUBE
SAMP VOL : 100 <ENTER> - START
R1/R2 VL : 200/0
D/R TIME : 180/0 INCUB T = 180

5. Add reagent in a tube and press <ENTER>. The analyzer will

compare the Sample absorbance with the absorbance that is fed as
Reaction absorbance limit (RX. ABSLIM). Simultaneously, the seconds
counter will start on a display, which shows the coagulation time. As
soon as the clot formation takes place, the sample absorbance crosses
the preset value that is (Rx abs lim), analysis ends and is indicated by
acoustic beep. If it is a two-reagent chemistry, at the click on <fn>, the
count down starts for READ T. At the end of this time, two beeps are
given and user is prompted to add the second reagent and click on
<ENTER> to start coagulation.

User Manual(Ver 0.0 Jun 08) 54

 PT (COAG.) T:37.0°C I.D.: 000001
FILTER : 505/000
STD.CONC : 13
FACTOR
SAMP VOL :
: 1
100
TIME: 35.8
R1/R2 VL : 200/0
D/R TIME : 180/0
<FN> FOR NEXT SAMPLE

6. The H/L flagging will be given with reference to N.V.MIN. and

N.V.MAX. values which are fed in parameters.

7. Press < ENTER > to print the result in INR (International normalized
range) which is calculated as

FACTOR
Sample result
INR =
STD. CONC.

STD. CONC. In this mode is normal value obtained for standard plasma.

I. SAMPLE BLANK
The operational steps are as follows:
1 Choose RUN TEST option from the opening screen. Press <ENTER> to
select a test with 1-Point Linear with Sample Blank mode and the below
screen is displayed.

ALB (SMP-BK ) T: 37.0°C I.D.:

0.000
FILTER : 340/000
RG. O.D. : 0
STD.CONC : 3.6 ABS:
FACTOR : 0
SAMP VOL : 3
R1/R2 VL : 500/0 ASPIARTE WATER
ASPAAA
DELAY T : 5
2 The RUN TEST screen will now display with the parameters that are
necessary for the analyzer to operate in this mode are displayed on the
screen.

3 Aspirate Distilled Water when “ASPIRATE WATER” is displayed on the

screen. The absorbance on the display will be set to “0”.

User Manual(Ver 0.0 Jun 08) 55

 4 If standard concentration value is entered as a non zero value in test
parameters then “ASPIRATE STANDARD BLANK” and “PRESS NO TO
SKIP” message is displayed alternately. Now Aspirate standard Blank
solution (RGT + STD), and wait for a few seconds to allow the solution to
stabilize in the flowcell. The analyzer displays the absorbance of the
Standard Blank Solution after the programmed delay time is over & then
gives prompt of “ASPIRATE STANDARD”. In this case aspirate standard
solution (RGT + STD.). However In case standard concentration value is
fed as “0” & calibration factor as any valid non zero value, Aspirate
Reagent Blank solution, as the analyzer displays “ASPIRATE REAGENT
BLANK” message and then wait for a few seconds to allow the solution to
stabilize in the flowcell. The analyzer displays the absorbance of the
Reagent Blank Solution after the programmed delay time is over & then
gives prompt of “ASPIRATE SAMPLE BLANK”. Now aspirate the
Sample solution. Wait for a few seconds, to allow the solution to stabilize
in the flowcell. The analyzer displays the absorbance of the Sample Blank
Solution after the programmed delay time is over.

4 The analyzer will now display “ASPIRATE CONTROL 1 BK”. You may
press <NO> to skip C1.Now next command displayed is “ASPIRATE
CONTROL 2 BK”. You may press <NO> to skip C2. The results of
control(s) obtained after thus analysis in this mode will be stored in
memory for Levy Jenning’s graph.

5 After this aspirate Sample or Control 1 or Control 2 when the display

shows “ASPIRATE SAMPLE” & “C1->UP C2->DOWN” or “ASPIRATE
CONTROL 1” or “ASPIRATE CONTROL 2” respectively. Sample Blank/
Control 1 Blank ABS/ Control 2 ABS is subtracted from Sample/ Control 1
ABS/ Control 2 ABS respectively. While analysing samples when
“ASPIRATE SAMPLE BLANK” is displayed, first feed the ID & then
aspirate sample blank solution ( RGT-1 + Sample). The display will show
the delta absorbance as well as the concentration of each sample.
6 After all readings are taken, Press the <RESET> key to return to the
“Home screen”. Wash the flowcell with distilled water, follow the
instructions on the display.

J. SAMPLE BLANK NON-LINEAR

1. Select RUN TEST from the Home screen. Select the required test from
the Analysis code screen and press <ENTER>. The following screen is
displayed:
APOB (SMP_BK_NL)
POINT TO POINT SPLINE √
<1> FOR CALIBRATION
<2> FOR GRAPH
<3> FOR SAMPLE RUN.
<fn>-SELECT METHOD
User Manual(Ver 0.0 Jun 08) 56
 2. Press <fn> to toggle between POINT TO POINT and SPLINE methods.
a. Press <1> FOR CALIBRATION.
b. Press <2> FOR GRAPH.
c. Press <3> FOR SAMPLE RUN.

3. To begin the procedure for curve calibration, press the numeric key <1>.
The calibration table seen on the display is as follows
APOB (SMP_BK_NL) 22/06/07 12:03:04
CONC. ABS. CONC. ABS.

STD1 0 0 STD4 121 0

STD2 25 0 STD5 0 0
STD3 66 0 STD6 0 0

4. Using the vertical cursors Ð Ï and the numeric keys enter the
concentration of the standards to be run. A minimum of 3 and a maximum
of 6 standards can be used. If the number of standards is less than six,
zero values must be entered against the corresponding standard number.
Press <CALIB> key to measure the actual absorbance and concentration
of the reagent and standards.
5. On pressing <CALIB> key the following screen is displayed:

APOB (SMP_BK_NL) T: 37.0°C

FILTER : 340/000
SAM VOL : 3
R1/R2 VL: 300/30
DELAY T : 5

ASPIRATE WATER

a. When the analyzer displays “ASPIRATE WATER” Aspirate distilled water

and wait for a few seconds. (The Analyzer automatically zero’s the ABS).
b. Aspirate the first standard when the analyzer displays “ASPIRATE
STANDARD 1” & “PRESS NO TO SKIP” & wait for the absorbance
reading to stabilize.
c. Repeat step ‘d’ for all standards in sequential order.

d. After all the standards have been aspirated the display returns to the
Calibration Table screen and displays the updated values. Press the
“PREV” key to return to the Non-Linear Test screen.
6. Press the numeric key <2> key to verify the interpolation curve. Display of the
graph will be seen on the screen. The statistical procedure used to elaborate
the curve is based on the method of least squared, cubic Spline interpolation
or Point-to-Point method, whichever is selected. This is the end of the

User Manual(Ver 0.0 Jun 08) 57

 calibration procedure. The curve obtained is stored in the memory of the
analyzer till recalibration is performed.

7. To run a sample, go back to the Non-linear Test Screen and press the
numeric key < 3 >.

8. Aspirate distilled water when the analyzer displays “ASPIRATE

WATER”. The absorbance on the display will be set to “0”. This
absorbance is subtracted from the sample absorbance, reagent
absorbance and standard absorbance.

9. Aspirate Sample Blank when “ASPIRATE SAMPLE BLANK” message is

displayed or Press <Ï> key then display will show “ASPIRATE
CONTROL 1 BK” for aspirating Control 1 Blank or Press<Ð> and then
display will show “ASPIRATE CONTROL 2 BK” for aspirating Control 2
Blank. After this aspirate Sample or Control 1 or Control 2 when the
display shows “ASPIRATE SAMPLE” & “C1->UP C2->DOWN” or
“ASPIRATE CONTROL 1” or “ASPIRATE CONTROL 2” respectively.
The Sample Blank ABS/ Control 1 Blank ABS/ Control 2 ABS is
subtracted from Sample ABS/ Control 1 ABS/ Control 2 ABS respectively.
The display will show the net absorbance as well as the concentration of
each sample.

10. After all readings are taken, Press the <PREV>key to return to the “Home
screen”. Wash the flowcell with distilled water.
NOTE : 1. Since the aspiration is by peristaltic pump it automatically clears
(For All the previous solution. It may not necessary to wash between the
Chemistries samples. This applies to all modes of operation.
) 2. <READ> key may be used to read a sample from the rectangular
polystyrene cuvette instead of using ASP switch for aspiration of
solution to flow cell.
3. Chemistries can also be performed using a predetermined factor.
In such cases the calibration step is skipped and the factor stored
in the memory is used for calculation. Thus after aspirate reagent
blank command you will get a command of aspirate control 1 if
control is programmed or aspirate sample will be displayed.
4. The total time required for a Kinetic assay is calculated as,
TOTAL REACTION TIME = DELAY TIME + (READ TIME x NO. )

User Manual(Ver 0.0 Jun 08) 58

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User Manual(Ver 0.0 Jun 08) 59

 CHAPTER VII
QUALITY CONTROL

Quality Control of a calibrated Biochemistry analyzer is the periodic monitoring of

the system performance by use of quality control specimens both in the normal
and abnormal range for comparison. The obtained data from the unit is
compared with previously obtained data. A variety of QC materials are available
for this use.

The analyzer can store data of 2 levels of controls for 31 days, for any of the 150
tests. The Mean (target) value and the 2 S.D. range (allowed variation from the
target) are fed into the analyzer. Data for each run (QC) is graphically plotted on
LEVY – JENNINGS control chart for each chemistry and for rapid or early
identification of trends.

USE OF REFERENCE / QUALITY CONTROL MATERIALS

Any commonly available Quality Control material can be used for the purpose of
quality check. Assayed serum control for Biochemistry, in the normal and
abnormal range is readily available. Calibration of the analyzer should be
checked daily in accordance with the requirement governing quality control in
your laboratory. Replicates run for the same analysis are regarded as another
sample and is retained. Thus a total of latest five values can be stored in the
analyzer for calibration verification for daily QC.

To ensure result accuracy following points should be followed while running

commercial control

1. Follow the manufacturer’s recommendations for reconstitution of each

vial.

2. Never use an open vial longer than recommended. Do not subject any vial
to excessive heat or agitation.

3. Verify the Lot No & Expiry of each vial.

4. When results of any analytes are flagged as “U” or “O” for under value
and over value respectively. Set limits; reconfirm calibration for that
parameter using specimens of known reference values only on L-J graph.

QC FILES

Results for each specimen run when a particular chemistry is selected are
automatically stored in that chemistry file. Results for the 150 tests are available

User Manual(Ver 0.0 Jun 08) 60

 at all times. All QC file stored data are available for Operator review on a printer
output.

Press numeric key < 3 > is on the “Home screen” to run Q.C. Reports. The test
menu screen is displayed. Select the required test and press <ENTER>. The
following screen is displayed:

*** QUALITY CONTROL REPORT ***

GLU (1-POINT )
<1>DAILY QC REPORT FOR C1
<2>DAILY QC REPORT FOR C2
<3>MONTHLY QC REPORT FOR C1
<4>MONTHLY QC REPORT FOR C2

Select the preferred option to generate QC Reports.

NOTE: If the Mean and standard deviation is not entered…Error message is

displayed as “PLEASE ENTER MEAN AND SD TO VIEW THE GRAPH”

A. Daily Quality Control

It is a plot of Standard Deviation (Y-axis) vs. the number of controls run (X- axis).
Data for each run (QC) is graphically plotted on LEVY – JENNINGS control chart for
each chemistry for rapid or early identification of trends. It gives the plot and the
result calculation for the latest five results of the control (C1/ C2) run.

a. Daily QC Report for C1:

This display is obtained after the numeric key < 1 > is pressed.

+3SD
+2SD X
RESULT

+1SD
X
MEAN X
-1SD
-2SD
-3SD
1 2 3 4 5

Printout of the Daily Quality Control Report for C1 can be obtained using the
“PRINT” key. Press <ENTER> to display calculated Mean and SD values.

User Manual(Ver 0.0 Jun 08) 61

 DAILY QUALITY CONTROL REPORT (C1)

MEAN:96.0 2SD:10.00
N:3
CALC-MEAN:94.8 CALC-SD: 1.2
CALC-CV:1.26

By pressing < fn > key daily quality control data is displayed. This can also be
printed pressing using <PRINT > key. This data can be deleted.

Daily QC Report for C2:

This display is obtained after the numeric key < 2 > is pressed.
Printout of the Daily Quality Control Report for C2 can be obtained using the
“PRINT” key.
Press <ENTER> to display calculated Mean and SD values.

DAILY QUALITY CONTROL REPORT (C2)

MEAN: 257.000 2SD: 22.0

N:3
CALC-MEAN:256 CALC-SD: 2.8
CALC-C.V.:1.09

By pressing < fn > key daily quality control data is displayed. This data can be
deleted.

B. Monthly Quality Control

It is a plot of Standard Deviation (Y-axis) versus the number of days in a month (X-
axis). Data for each run (QC) is graphically plotted on LEVY – JENNINGS control
chart for each chemistry and for rapid or early identification of trends. It gives the plot
and the result calculation for the last 31 days of the control (C1/ C2) run.

User Manual(Ver 0.0 Jun 08) 62

a. Monthly Quality Control for C1:
This display is obtained after the numeric key < 3 > is pressed:

+3SD
+2SD
RESULT +1SD
MEAN X
-1SD X X X X
-2SD
-3SD
1 5 10 15 20 25 30

The monthly Mean and Standard Deviation 2SD is displayed on the screen.
Printout of the Monthly Quality Control Report for C1 can be obtained using the
“PRINT” key.
Press <ENTER> to display calculated Mean and SD values.

MONTHLY QUALITY CONTROL REPORT (C1)

MEAN: 96.0 2SD: 10.00

N:5
CALC-MEAN:94.7 CALC-SD: 1.3
CALC-MEAN:1.37

By pressing < fn > key daily quality control data is displayed. This data can be
deleted.
b. Monthly Quality Control for C2:
This display is obtained after the numeric key < 4 > is pressed:
The monthly Mean and Standard Deviation 2SD is displayed on the screen.
Printout of the Monthly Quality Control Report for C2 can be obtained using the
“PRINT” key.
Press <ENTER> to display calculated Mean and SD values.
MONTHLY QUALITY CONTROL REPORT (C2)

MEAN:257.000 2SD:22.0
N:7
CALC-MEAN:254 CALC-SD:2.1
CALC-C.V.:0.82

By pressing < fn > key daily quality control data is displayed. This can also be
printed pressing using <PRINT > key. This data can be deleted.

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 CHAPTER VIII
PATIENT REPORTS:
Reports can be obtained by pressing the numeric key <4> in the “Home screen”.
It allows the printing of the results obtained in the analysis for each patient. The
Patient Report can be obtained by: Date, I.D. and by Date and I.D.

*** REPORTS ***

1. COLLATED REPORT BY DATE.

2. COLLATED REPORT BY I.D.
3. COLLATED REPORT BY DATE AND I.D.

Press the numeric keys < 1 >, < 2 > or < 3 > for Collated Report by date, Collated
Report by I.D. or Collated Report by Date and I.D. respectively.

A. Collated Report by Date:

The screen for Collated Report by Date is as follows:

*** COLLATED REPORT BY DATE ***

DATE: 14/08/06

Enter date in DD/MM/YY format and press <ENTER> to confirm. The following
screen is displayed.

SCANNING REPORTS…..
DATE : 14/08/06

SCANNING REPORTS.....
DATE: 14/08/06

SAMP01 14/08/06 ALB 2.999 g/dl L

SAMP04 14/08/06 CAA 3.821 mg/dl L
SAMP06 14/08/06 ALB 8.771 g/dl H
SAMP07 14/08/06 GLU 169.4 mg/dl H
SAMP09 14/08/06 ALB 4.115 g/dl H

User Manual(Ver 0.0 Jun 08) 65

 *** COLLATED REPORT BY DATE ***
DATE: 14/08/06

SAMP01 14/08/06 ALB 2.999 g/dl L

SAMP04 14/08/06 CAA 3.821 mg/dl L
SAMP06 14/08/06 ALB 8.771 g/dl H
SAMP07 14/08/06 GLU 169.4 mg/dl H
SAMP09 05/11/05 ALB 4.115 g/dl H

Use ↑↓ arrow keys to scroll the page UP and DOWN to view the
remaining results.

B. Collated Report by I.D.

The screen for Collated Report by ID is as follows:

*** COLLATED REPORT BY I.D. ***

SAMPLE ID: SAMP09
:

ENTER SAMPLE ID USING ALPHANUM

KEYS. USE RIGHT AND LEFT ARROW
KEYS TO MOVE THE CURSOR.
<ENTER> - TO CONFIRM
Enter Sample ID using alphanumeric keys. Use right and left arrow keys to move
the cursor. Press <ENTER> to confirm. The following screen is displayed:

SCANNING REPORTS…..
SAMPLE ID : SAMP09

SCANNING REPORTS.....
SAMPLE ID : SAMP09

SAMP09 14/08/06 ALB 2.999 g/dl L

SAMP09 14/08/06 GLU 169.4 mg/dl H
SAMP09 14/08/06 GLU 172.2 mg/dl H
SAMP09 14/08/06 ALB 3.174 g/dl L

User Manual(Ver 0.0 Jun 08) 66

 *** COLLATED REPORT BY I.D. ***
SAMPLE ID : SAMP09

SAMP09 05/11/05 ALB 2.999 g/dl L

SAMP09 05/11/05 GLU 169.4 mg/dl H
SAMP09 05/11/05 GLU 172.2 mg/dl H
SAMP09 05/11/05 ALB 3.174 g/dl L
SAMP09 05/11/05 CAA 3.821 mg/dl L

Use ↑↓ arrow keys to scroll the page UP and DOWN to view the remaining results.

C. Collated Report by Date and I.D.

This allows the user to change the date as well as the patient I.D.

** COLLATED REPORT BY DATE AND I.D. **

DATE: 05/11/05 SAMPLE ID:SAMP09

ENTER DATE(DD/MM/YY) AND ID

<fn> - SELECT DATE OR ID
<ENTER> - TO CONFIRM

Enter date in DD/MM/YY format and ID. Press <fn> to toggle between Date and ID.
Press <ENTER> to confirm. The following screen is displayed:

SCANNING REPORTS…..
DATE : 14/08/06 SAMPLE ID : SAMP09

User Manual(Ver 0.0 Jun 08) 67

 SCANNING REPORTS.....
DATE :14/08/06 SAMPLE ID :SAMP09

SAMP09 14/08/06 ALB 2.999 g/dl L

SAMP09 14/08/06 GLU 169.4 mg/dl H
SAMP09 14/08/06 CAA 3.641 mg/dl L
SAMP09 14/08/06 ALB 3.174 g/dl L

*** COLLATED REPORT BY DATE AND I.D. **

DATE :14/08/06 SAMPLE ID :SAMP09

SAMP09 14/08/06 ALB 2.999 g/dl L

SAMP09 14/08/06 GLU 169.4 mg/dl H
SAMP09 14/08/06 CAA 3.641 mg/dl L
SAMP09 14/08/06 ALB 3.174 g/dl L
SAMP09 05/11/05 ALB 4.115 g/dl

Use ↑↓ arrow keys to scroll the page UP and DOWN to view the remaining results.

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 CHAPTER IX
MAINTENANCE AND ANALYZER CARE

The analyzer is designed for trouble free operation and requires minimum
maintenance. For good functioning of the analyzer it is advisable to follow the
instructions given below:
1. Handle the analyzer with care and keep it clean.
2. When not in use, cover the analyzer with the dust cover to avoid
accumulation of dust.
3. Though air conditioning is not a must, it is advisable to keep the analyzer
in a dust free, cool atmosphere, away from direct sunlight.

A. DAILY MAINTENANCE

1. Wipe off any reagent spills on the analyzer immediately.

2. After every chemistry run, wash the flowcell thoroughly with good quality
distilled water using the “fn” Key.
3. Always leave the flowcell filled with distilled water. Never leave any
reaction mixture in it.
4. At the end of each day, aspirate Erba cleaning solution into the flowcell
and leave it filled overnight. Every morning aspirate distilled water 5-6 ml
to thoroughly rinse the flowcell.
5. Empty the waste solution bottle every evening.

CAUTION:
1. DO NOT USE STRONG ACIDIC OR ALKALINE SOLUTIONS WHICH
CAN CAUSE IRREPAIRABLE DAMAGE TO THE ANALYZER.
2. DO NOT LEAVE THE FLOWCELL DRY. ALWAYS LEAVE IT FILLED
WITH DISTILLED WATER DURING THE DAY AND WITH CLEANING
SOLUTION AT NIGHT.

NOTE : It is advisable to carryout the peristaltic pump calibration every week in

order to compensate for the change in elasticity of the tubing.

B. QUARTERLY MAINTENANCE

Replace the aspiration tubing and peristaltic pump tubing once every THREE
months (as explained below) or earlier if it shows signs of wear and tear.

Failure to change the peristaltic pump tubing in time can cause serious
NOTE: errors of aspiration volumes and can also damage the analyzer due to
the leakage of corrosive reagents through torn tubing. Also, the change
in peristaltic pump tubing should be followed by Pump Calibration
procedure.

User Manual(Ver 0.0 Jun 08) 70

 Besides the above, certain other simple maintenance operations have to be
performed as and when required.

These are :
- Replacement of the paper roll
- Replacement of tubings.
C. REPLACEMENT OF TUBING

The replacement has to be carried out once in THREE months, or whenever an alteration
in the aspiration volume occurs. Disconnect the tubing from the peristaltic pump if the
analyzer is not going to be operated for a few days or longer.

a. ASPIRATION TUBE REPLACEMENT

1. Open the Photometer Cover.

2. Gently remove the flow cell from the cuvette holder assembly.

User Manual(Ver 0.0 Jun 08) 71

 3. Unscrew the aspiration tubing from the flow cell.

4. Slide out the washer and ‘O’ ring of the old aspiration tubing.

5. Discard the old aspiration tubing onto an appropriate location as it is

biohazardous.
6. Slide in the washer and ‘O’ ring into the new aspiration tubing.
7. Lock it to the flow cell with the plastic screw available.
8. Place the flow cell back into the cuvette holder assembly.
9. Pass the end of the aspiration tube through the holder and pull it out so that
the length is adequate.
10. Aspirate distilled water.
11. Close the flap of the cuvette housing.

Note: Take care to see the side of the flowcell with the arrow mark is in light path &
to your left. & always leave it filled with distilled water whenever not in use.

User Manual(Ver 0.0 Jun 08) 72

 b. REPLACEMENT OF PERISTALTIC PUMP TUBINGS

1. Remove the cover of peristaltic pump housing.

2. Before the old tube is removed, note the exact manner in which it is positioned
around the pump.

3. Release the peristaltic pump tubing.

4. Detach both the ends of the tubing from Aspiration tubing and Waste tubing
respectively.

User Manual(Ver 0.0 Jun 08) 73

 5. Insert the one end of new peristaltic tubing assembly into the tubing coming from
Flow cell.
6. Position the new tubing around the rotor.
7. Insert the other end of peristaltic tubing into the waste tube and direct the waste
tube towards waste bottle.
8. Perform pump calibration with 1 ml distilled water.
Note: Perform WASH with 3 ml DI Water to fill the tube up to Peristaltic pump
before proceeding for Pump Calibration.
9. Put the cover of the peristaltic pump housing.

D. REPLACEMENT OF LAMP ASSEMBLY

1. Open the Photometer Cover.

2. Unscrew the thumbscrew and remove lamp cover.

3. Before the old lamp is removed, note the exact manner in which it is positioned.
4. Unscrew the two lamp terminals using (--) screw driver.

User Manual(Ver 0.0 Jun 08) 74

 5. Unscrew the thumbscrew provided on the lamp holder.

6. Pull out the lamp.

7. Place a new lamp and connect the lamp terminals and fix thumbscrews.
8. Refit the lamp cover.

NOTE: Due to the aging effect the lamp intensity may get reduced and results
may be improper, it is advisable to replace the lamp after every six month.

E. REPLACEMENT OF PRINTER PAPER

Before starts the instrument makes sure that enough printer paper is on the roll. The
paper roll is located under the printer cover. To check and/or replacing the paper roll
lift off the printer cover. For inserting a new paper roll do as follows.

1. Lift off the printer cover and take the roll out of the paper roll housing.

2. Then take a new paper roll and lay down into the paper roll housing.

3. Release the printer lever by pulling it upward.

User Manual(Ver 0.0 Jun 08) 75

 4. Cut the paper in the shape as shown in the figure below and then feed this
paper tongue into the slot of the paper feeder. Smoother side should face up.

5. Close the printer lever by pressing it down and close the printer cover.

6. Press PAPER FEED key provided on the keypad to advance the paper.

WARNING: BEFORE REMOVING COVER SWITCH OFF POWER SUPPLY

!

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 CHAPTER X
TROUBLE SHOOTING GUIDE

1. Liquid is not aspirated a) Check if peristaltic pump tubing is

when the ASPIRATION connected properly, if not reconnect
switch is pressed correctly.

b) Perform pump calibration again.

c) ‘ASP’ switch may be defective.

d) Call Service Engineer.

2. Peristaltic Pump a) Ensure that pump tubing and aspiration

operates but liquid is tubing are properly connected.
not aspirated.
b) Check tubings for blockage, crimps or
leaks.

c) Perform pump calibration again.

d) Replace tubings.

e) Call Service Engineer.

5. The graph of a Kinetic a) The graph of a Kinetic chemistry is never

chemistry is not printed printed along with the result automatically.
along with the result.
b) A printout of the graph can be obtained by
using the ‘PRINT’ key after getting the
graph on display.

6. The temperature attained a) Call Service Engineer.

in the flowcell is not with in
± 0.1º C of the set Temperature

7. Poorly reproducible & a) Check if the aspiration volume that is

erratic readings. programmed and then check whether the
same amount of liquid aspirated is as
programmed.

b) If it is found that the aspiration is not proper

User Manual(Ver 0.0 Jun 08) 78

 then perform pump calibration.

c) Check expiry date of the reagents and

control material used.

d) Check if all the necessary precautions have

been taken. Always use clean glassware.

8. Control values not within range. a) Ensure that the procedures specified
by the reagent manufacturer are followed.
b) Check the wavelength, temperature,
sample and reagent volumes, factor a nd
std. concentration. In case of Kinetic
chemistries make sure that the Delay time
Rate time, and Read number are correctly
programmed.

c) Check reagents, controls and standards for

expiry.

d) Ensure that water used for the reconstitution of

dry powder reagents is of reagent grade quality
i.e. De-ionized water or Double Distilled water.

9. The result printout is

accompanied by the a)The initial absorbance of reagent is
warning “ CRITICAL is less than the RG. ABS LIM.
REAGENT ABSORBANCE” in value test parameters.
ALL chemistries.
b) Check if the “RG. ABS LIM.” value has been
correctly entered.

c) Prepare fresh reagent and repeat the test.

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 CHAPTER XI

LIST OF CONSUMABLES REQUIRED FOR Chem-5v3

For a continuous and trouble free working of CHEM-5V3, it is a recommended to keep

certain spare consumables handy.

One set of the items mentioned below is also supplied along with the instrument as
standard accessories. It is recommended to store the consumables/spare in the original
packing until the actual use.

Sr. Item Code Description Qty.

No.
1 LMATU000014NEBN PERISTALTIC TUBE ASSEMBLY 04
TUBE TEFLON (ID: 0.75mm;OD: 1.5mm x
2 RELTB000003NIBN 01
210mm)-FLANGED ASPIRATION TUBE
3 LMACH000004NIAN Lamp Assembly 01

4 RCNTP000005NLCN Printer Paper Roll 57 mm x 30 m (set of 3) 03

5 RLCOT000004NIBN Polystyrene Rectangular Microcuvette 10

6 REKT 921 ERBA WASH KIT (4 x 50 ml) 01

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