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Operator Manual

For

Semi-Automated Clinical Chemistry Analyzer

Document Version: 2012.01.01

Last Updated: 17 October 2012


Operator Manual CHEM-7

Foreword
This manual is organized in a progressive sequence for easy study and reference. It is an
instructional aide to provide a reference for easy operation and general maintenance of
this analyzer. It contains detailed description of the analyzer features and specifications.

Use of the analyzer with proper knowledge will ensure quality test results and trouble free
analyzer operation with optimum performance.

This operation manual is prepared based on the assumption that the user has knowledge
of clinical chemistry.

Before operating the analyzer, user should:

1. Read and understand this manual.

2. Be trained by authorized person.

3. Be familiar with the operation of the analyzer.

NOTE: Keep this manual in an easily accessible place.

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Operator Manual CHEM-7

Legal Information
All rights are reserved by manufacturer of this product.

Manufacturer is the copyright owner of this document.

The contents of this document are subject to change without prior notice and without legal
obligation.

This document and the information herein are provided for the sole use of the intended
recipient(s) and for information purposes only.

This document contains contents which are the confidential and proprietary information of
the manufacturer.

This document cannot be modified, reproduced, translated or transmitted in any form or


by any means for any purpose, without prior written permission from the manufacturer.

No part of this document can be copied or reprinted, in whole or in part, without prior
written permission from the manufacturer.

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Operator Manual CHEM-7

Contact Us
We welcome your feedback about the product. You can reach us at the following.

Address Erba Diagnostics Mannheim GMBH, Mallaustrasse 69 – 73, 68219,


Mannheim, Germany
Website www.erbamannheim.com
Phone 49-621- 8799770
Fax 49-621- 8799688
Email sales@erbamannheim.com

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CONTENTS
1. OVERVIEW OF ANALYZER ........................................................................................1-1
1.1. INTRODUCTION ....................................................................................................1-1
1.2. ANALYZER VIEW...................................................................................................1-2
2. SAFETY ........................................................................................................................2-1
3. ANALYZER FEATURES ..............................................................................................3-1
3.1. HARDWARE SPECIFICATIONS............................................................................3-1
3.2. SOFTWARE SPECIFICATIONS ............................................................................3-2
3.3. KEYBOARD DESCRIPTION ..................................................................................3-4
3.4. ASPIRATION SWITCH ...........................................................................................3-5
3.5. SAFETY ..................................................................................................................3-5
4. INSTALLATION ............................................................................................................4-1
4.1. INSPECTION ..........................................................................................................4-1
4.2. UNPACKING ..........................................................................................................4-1
4.3. INSTALLATION REQUIREMENTS ........................................................................4-2
4.4. ELECTRICAL REQUIREMENTS ...........................................................................4-2
4.5. INSTALLATION PROCEDURE ..............................................................................4-3
4.6. PRINTER HOUSING AND PRINTER PAPER INSTALLATION ............................4-3
4.6.1. INTERNAL PRINTER ..................................................................................................4-3
4.6.2. EXTERNAL PRINTER.................................................................................................4-4
4.6.3. PC COMMUNICATION ...............................................................................................4-4
4.7. EXTERNAL KEYBOARD INSTALLATION .............................................................4-4
5. PRINCIPLES OF OPERATION ....................................................................................5-1
5.1. MODES OF OPERATION ......................................................................................5-1
5.1.1. ABSORBANCE MODE................................................................................................5-1
5.1.2. ONE POINT LINEAR MODE .......................................................................................5-1
5.1.3. TWO POINT LINEAR MODE ......................................................................................5-1
5.1.4. RATE A LINEAR MODE..............................................................................................5-1
5.1.5. SAMPLE BLANK LINEAR MODE ...............................................................................5-1
5.1.6. CONCENTRATION (NON-LINEAR) MODE ................................................................5-1
5.1.7. COAGULATION MODE ..............................................................................................5-2
5.2. READING THE CUVETTE .....................................................................................5-2
5.3. CARRYOVER AND ASPIRATION VOLUME .........................................................5-2
5.4. CALCULATION OF THE KINETIC TEST RESULTS .............................................5-3
5.5. ADDITIONAL CUVETTE HOLDER ........................................................................5-4
6. SETTINGS.....................................................................................................................6-1
6.1. PROGRAM MENU..................................................................................................6-1
6.2. SYSTEM SETUP ....................................................................................................6-3
6.2.1. SYSTEM PARAMETERS ............................................................................................6-4
6.2.2. CONTROL DATA ........................................................................................................6-9
6.2.3. NORMAL RANGES .....................................................................................................6-9
6.2.4. CALCULATION ITEMS .............................................................................................6-10
6.3. ANALYSIS CODE GENERATION ........................................................................6-12
6.4. SETTING OF PARAMETERS ..............................................................................6-15
6.5. PARAMETER DEFINITIONS AND VALUES .......................................................6-16

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7. MODES OF OPERATION .............................................................................................7-1


7.1. ABSORBANCE MODE ...........................................................................................7-1
7.2. 1-POINT LINEAR MODE ........................................................................................7-2
7.3. 2-POINT LINEAR MODE ........................................................................................7-4
7.4. RATE A LINEAR MODE .........................................................................................7-7
7.5. 1-POINT NON LINEAR MODE...............................................................................7-9
7.6. 2-POINT NON LINEAR MODE.............................................................................7-14
7.7. RATE A NON LINEAR MODE ..............................................................................7-16
7.8. 1-POINT LINEAR WITH SAMPLE BLANK ...........................................................7-16
7.9. 1-POINT NON-LINEAR WITH SAMPLE BLANK .................................................7-17
7.10. COAGULATION MODE ......................................................................................7-20
8. REPORTS .....................................................................................................................8-1
8.1. QUALITY CONTROL ..............................................................................................8-1
8.1.1. QUALITY CONTROL SCREEN ..................................................................................8-1
8.1.2. DAILY QUALITY CONTROL .......................................................................................8-3
8.1.3. MONTHLY QUALITY CONTROL ................................................................................8-5
8.2. COLLATED REPORTS ..........................................................................................8-7
8.2.1. COLLATED REPORT BY DATE .................................................................................8-8
8.2.2. COLLATED REPORT BY I.D ......................................................................................8-9
8.2.3. PATIENT REPORT BY DATE AND I.D .......................................................................8-9
8.2.4. PATIENT REPORT BY DATE AND TEST ................................................................8-10
8.2.5. PATIENT REPORT ON EXTERNAL PRINTER ........................................................8-10
9. MAINTENANCE ............................................................................................................9-1
9.1. SELF TEST .............................................................................................................9-1
9.2. PUMP CALIBRATION ............................................................................................9-1
9.3. DAILY MAINTENANCE ..........................................................................................9-3
9.4. QUARTERLY MAINTENANCE ..............................................................................9-3
9.5. REPLACEMENT OF TUBING ................................................................................9-4
9.5.1. ASPIRATION TUBE REPLACEMENT ........................................................................9-4
9.5.2. REPLACEMENT OF PERISTALTIC PUMP TUBINGS ...............................................9-5
9.6. REPLACEMENT OF LAMP ASSEMBLY ...............................................................9-7
9.7. REPLACEMENT OF PRINTER PAPER ................................................................9-8
10. TROUBLE SHOOTING GUIDE ................................................................................10-1
11. LIST OF CONSUMABLES .......................................................................................11-1
12. ANNEXURE ..............................................................................................................12-1
12.1. RESULT TRANSMISSION PROCEDURE USING USB CABLE .......................12-1
12.2. RESISTANCE VERSUS TEMPERATURE ........................................................12-2
13. REVISION HISTORY ................................................................................................13-1

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1. OVERVIEW OF ANALYZER
1.1. INTRODUCTION
The CHEM-7 hereafter referred as an analyzer is a Compact, High performance,
16-bit micro controller based semiautomatic biochemistry analyzer for Routine
Chemistries, Electrolytes, Immunoassays, Hormones, Coagulation and Drug tests.
There are 10 modes of operation, including the coagulation mode. Programming,
reading and reporting operations are user friendly.
Operation is through a soft-touch keyboard with quick shift from one function to
another without going through complex sequential operations.
The analyzer is provided with a 320x240 dots LCD with LED backlight display with
alphanumeric and graphic capabilities.
A patient-wise collated report is obtained upon request. Exhaustive quality control
data at 3 levels, for any of the tests is also stored in the memory of the analyzer.
The software is complete with the device diagnostics self-test function, capable of
providing timely flag / error messages related to test results or analyzer
malfunctioning.
The State-of-Art features, advanced optics, versatile analytical capabilities and
economy of 18μl (33μl optional) flowcell makes it the analyzer of choice for all
laboratories.
This analyzer is intended to be used:
z For In-vitro quantitative and qualitative determination of wide range of
analytes in body fluids.
z By the trained personnel in controlled environment and continuously
monitored operation.

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1.2. ANALYZER VIEW

PHOTOMETER COVER PRINTER COVER

DISPLAY KEYPAD

ASPIRATION TUBE ASP SWITCH

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PC TRANSMISSION PORT INCUBATOR CONNECTOR

EXTERNAL KEYBOARD
EXTERNAL PRINTER
PORT

DC INPUT SUPPLY
PERISTALTIC PUMP COVER
CONNECTOR

ON/OFF SWITCH

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This Page is Intentionally Left Blank

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2. 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 these
safety precautions before installation/use and follow the directions.
z Only qualified personnel should use the analyzer.
z While operating, maintaining, servicing or repairing the analyzer, follow all
the procedures described in this manual.
z Always ensure that mains switch is OFF while connecting or removing or
servicing the analyzer.
z Observe all WARNINGS and CAUTIONS posted on the system or
described in this manual.
z Avoid contact with all electrical circuits of analyzer; observe CAUTIONS
posted on the analyzer.
z Never use substitute parts on the analyzer or modify it in any way.
z Keep the analyzer out of the rain and any other water splash. Pay attention
to inclination, vibration, shock etc.
z During the operation photometric lamp becomes extremely hot. DO NOT
look directly into the light path of the lamp when it is ON. DO NOT touch the
lamp when it is ON.
z If the lamp needs to be changed, always switch off the lamp by switching off
the analyzer and then wait for minimum 10-minutes/until lamp has cooled
down.
z Avoid using dangerous flammable material around the analyzer. Fire or
explosion may be caused by ignition.
z Avoid areas that are adversely affected by atmospheric pressure,
temperature, humidity, ventilation, sunlight, dust and air containing salt,
sulfur, etc.
z Operator is responsible for taking all necessary precautions against hazards
associated with the use of clinical laboratory chemicals. Specific
recommendations for each reagent used with the analyzer are normally
found on the manufacturer’s package inserts or on product information
sheets for each chemical. Wipe up any reagent spillage on the analyzer
immediately.
z Pay attention not to exceed time and volume necessary for diagnosis. Keep
monitoring the behavior of whole system in order to detect any malfunction.
z Take immediate corrective measures including shutdown of operation when
any malfunction is detected in the analyzer.

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z In the event of trouble, do not play with the analyzer and leave any repair
work to an authorized expert.
Caution: NEVER OPERATE ON A WET OR DAMP SURFACE.

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3. ANALYZER FEATURES
3.1. HARDWARE SPECIFICATIONS
1 SYSTEM TYPE Open, Flowcell.
2 MEASUREMENT Colorimetry (Rate/EndPoint), Turbidometry, Immunoassay
PRINCIPLE
3 APPLICABLE ANALYTES Photometric assays – Enzymes, lipid, protein, Sugar,
Inorganic substances & others.
Turbidometric Assay – IgG, IgA, C3, C4, RF etc.
4 SETUP Benchtop.
5 LIGHTSOURCE Quartz Halogen Lamp, 12V, 20 Watts.
6 PHOTOMETRIC RANGE 0 ~ 2.5 O.D. (Range 340~670nm)
Resolution 0.0001.
7 OPTICS 8 wavelength static photometric group with following
interference filters: 340, 405, 450, 505, 546, 578, 600, 670
nm.
8 DETECTORS 8 UV / VIS Silicon photodiodes.
9 CUVETTE Unique triple cuvette system:
ƒ 18 μl Flow cell or 33 μl (optional)
ƒ 10 mm square cuvette
ƒ 6 mm round Glass Tube with adapter for
Coagulation and Elisa tests.
10 THERMOSTAT Peltier temperatures control from 20q-40qC ±0.1qC
11 MEASUREMENT VOLUME 18μl (33 μl optional)
12 SAMPLE ASPIRATION By means of a peristaltic pump, Aspiration Volume
programmable from 200 μl to 999 μl.
13 PRECISION Better than 1% CV.
14 KEYBOARD Rugged water proof keyboard.
41 fixed and 6 dynamic keys.
15 SMPS EXTERNAL(18/24V DC; 70/100W)
16 PRINTER High resolution, 384 dots per line, thermal type with full
graphics facility and option for connecting external USB
printer
17 DISPLAY: High resolution Graphics LCD 320x240, with LED
backlight. View area: 120x92 mm
18 INTERFACES USB B type port for host computer and USB A type port
for External USB DeskJet Printer.
External PC/AT keyboard.
19 PROCESSOR: 16-bit with 384KB Flash Memory
20 MEMORY: 2MB serial flash and 2MB EEPROM for storage of Patient
data, QC and Chemistry Parameters
21 REAL TIME CLOCK: Built in.
22 REPLACEABLE BATTERY Lithium Battery CR2032 (3v)

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ON PCB:
23 WASTE COLLECTION Waste collected in closed container.
24 INCUBATOR: Optional external incubator.
25 OPERATING 20 – 40 °C
TEMPERATURE
26 STORAGE TEMPERATURE -10 to + 50 °C.
27 HUMIDITY Max.80% RH, non-condensing.
28 MAINS SUPPLY 115/230V AC (±10%), 50/60 Hz (converted to 18~24V DC
using External Universal Power adapter, power
70W~100W.
29 SIZE: 220(H) x 430 (W) x 235 (D) mm
30 WEIGHT: Approximately 5 kg.
NOTE:
z Above specifications subject to change without prior notice.

3.2. SOFTWARE SPECIFICATIONS


z 10 analytical modes of operation:
ƒ 1-point Linear.
ƒ 2-point Linear.
ƒ Rate A Linear.
ƒ 1-point Non-Linear (Cubic Spline / Point to point / Logit Log).
ƒ 2-point Non-Linear (Cubic Spline./ Point to point / Logit Log).
ƒ Rate A Non-Linear (Cubic Spline / point to point / Logit Log).
ƒ 1-point Sample Blank Linear.
ƒ 1-point Sample Blank Non-linear (Cubic Spline / point to point / Logit
Log).
ƒ Absorbance.
ƒ Coagulation.
z 200 totally “open” test programs selectable through keypad.
z Parameters can be viewed, edited, and printed.
z Facility to memorize reagent blank O.D., Standard O.D., Factor and Non-
linear curve for 10 Standards including Standard 0.
z Facility to set replicates (1-3) for standard and sample. Final result
calculation is done by averaging replicate results.
z Patient report for last 1000 results stored in memory are obtained by
ƒ Date.

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ƒ I.D.
ƒ By Date and I.D.
ƒ By Date and Test Name.
z Graphic presentation of Non Linear calibration curves.
z QC (Levy Jennings Chart available for three controls per test)
ƒ Daily QC.
ƒ Monthly QC.
z Facility to view and edit control values of 3 levels (C1/C2/C3) at a glance for
each chemistry.
z Facility to view and edit Normal ranges of 3 sample types (Male/Female/
Infant) at a glance for each chemistry.
z Five fixed calculation items for calculation of certain parameters from the
previously run chemistry results.
z Rate calculation by linear regression method.
z Online reaction graph for Rate and Two point Assays
z Automatic zeroing.
z Total reaction time:
ƒ Selectable Delay Time between 5 seconds and 999 seconds.
ƒ Selectable Read Time between 5 seconds and 999 seconds.
ƒ Selectable Read Number between 5 seconds and 999 seconds.
z Non-linear calibration (10 Standards including Zero Standard) with 3
methods.
ƒ Point to Point.
ƒ Spline.
ƒ Logit Log.
z Variable temperature range. (20-40qC) in steps of 1qC with accuracy of r
0.1qC.
z On-line reagent stability check.
z Substrate depletion / Non-linearity check.
z Monochromatic as well as bichromatic measurements possible.
z Calibration of peristaltic pump.
z On-line display of cuvette temperature.

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z On-line help.
z Self-diagnostics.
z Help messages on erroneous entry.
z Reports can be printed on USB Printer or Thermal Printer by either using
PRINT key.

3.3. KEYBOARD DESCRIPTION

KEY DESCRIPTION
There are 6 dynamic keys, which are LCD display
screen specific.

These keys are used for entering a number from 0 to 9


as seen on the key.

TO

This key is used to enter negative sign or decimal point


when required. If pressed once the ‘-’ sign can be
entered. If pressed twice the decimal point ’.’ gets
entered.
The paper feed key is used to advance the printer paper
by 1 line.

This is a software reset key used to reset the analyzer


without resetting the memory.

This is an indication LED which blinks when Wash or


Asp key are pressed. It indicates that the peristaltic

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pump is in action. The LED stops blinking after 5ml of


water is aspirated or when the programmed volume of
liquid is aspirated.
There are 28 multifunction keys, which act as 56 direct
chemistry access function keys. The function of this key
depends on number of times the key is pressed. If
pressed once chemistry written on the top of the key
gets activated and if pressed twice chemistry mentioned
at the lower part of the key gets activated.
E.g. If pressed once GLU will activate and if pressed
twice GHb gets activated.
The same key is used to enter the alphabets from ‘A’ to
TO
‘Z’ and ‘a’ to ‘z’ indicated on the right top corner of the
direct chemistry access key. These alphabets can be
utilized to enter laboratory information or sample ID.
E.g. If pressed once capital letter ‘A’ to ‘Z’ will be
entered and when pressed twice small letters ‘a’ to ‘z’
gets entered for the corresponding key.

3.4. ASPIRATION SWITCH


The Switch Actuator is located at right hand side below the aspiration tube which is
provided for aspiration of liquid into the flow cell and for washing flow cell.

3.5. 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 these
safety precautions before installation/use and follow the directions.
z Only qualified personnel should use the analyzer.
z While operating, maintaining, servicing or repairing the analyzer, follow all
the procedures described in this manual.
z Always ensure that mains switch is OFF while connecting or removing or
servicing the analyzer.
z Observe all WARNINGS and CAUTIONS posted on the system or
described in this manual.

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z Avoid contact with all electrical circuits of analyzer; observe CAUTIONS


posted on the analyzer.
z Never use substitute parts on the analyzer or modify it in any way.
z Keep the analyzer out of the rain and any other water splash. Pay attention
to inclination, vibration, shock etc.
z During the operation photometric lamp becomes extremely hot. DO NOT
look directly into the light path of the lamp when it is ON. DO NOT touch the
lamp when it is ON.
z If the lamp needs to be changed, always switch off the lamp by switching off
the analyzer and then wait for minimum 30-minutes/until lamp has cooled
down.
z Avoid using dangerous flammable material around the analyzer. Fire or
explosion may be caused by ignition.
z Avoid areas that are adversely affected by atmospheric pressure,
temperature, humidity, ventilation, sunlight, dust and air containing salt,
sulfur, etc.
z Operator is responsible for taking all necessary precautions against hazards
associated with the use of clinical laboratory chemicals. Specific
recommendations for each reagent used with the analyzer are normally
found on the manufacturer’s package inserts or on product information
sheets for each chemical. Wipe up any reagent spillage on the analyzer
immediately.
z Pay attention not to exceed time and volume necessary for diagnosis. Keep
monitoring the behavior of whole system in order to detect any malfunction.
z Take immediate corrective measures including shutdown of operation when
any malfunction is detected in the analyzer.
z In the event of trouble, do not play with the analyzer and leave any repair
work to an authorized expert.
Caution: NEVER OPERATE ON A WET OR DAMP SURFACE.

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4. INSTALLATION
4.1. INSPECTION
The analyzer is tested before shipment and is packed carefully to prevent any
shipping damage. It is user’s 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.

4.2. UNPACKING
The main unit and accessories are packed in single carton; other additional
accessories such as power cord may be packed in another carton. The
representative is responsible for unpacking, installing and initial setting up of the
analyzer.
Serial Item Code Description Quantity
Number
1 111067 POWER ADAPTER AC ( O/P : 18 VDC ; 100 W ) 1 NO.
PPS100A-13 (00A) L - TYPE
2 110343 TYPE E / F PLUG - M2511 / U16CS3 V1625 HO5 VVF 1 NO.
3 X 1SQ.mm 2MTR. LENGTH
3 110309 THERMAL PAPER ROLL (57 mm X 30 m) FOR 03 ROLL
PRINTER
4 110035 ASSEMBLY WASTE BOTTLE FOR 1 NO.
CHEM7/EC5V2/CHEM5X/CHEM5V3
5 110956 COVER FOR DUST CHEM 7 1 NO.
6 -- Operator Manual for CHEM-7 NS (Export) 1 NO.
7 110973 HOLDER TEST TUBE FOR EC5 1 NO.
8 110945 CUVETTES ROUND GLASS MICRO ID 6 mm OD 8 10 NOS.
mm
9 110347 MICRO CUVETTE RECTANGULAR POLYSTYRENE 10 NOS.
10 110661 ALLEN KEY SIZE 3 mm 1 NO.
11 120232 ERBA WASH (4 X 50 ml) 1 NO.
110020 PM KIT – CHEM-7 PH II WITH 2 x 5.5 PERISTALTIC 1 NO.
TUBE ASSEMBLY
1 110018 ASSEMBLY LAMP 1 NO.
2 110353 SYRINGE 5 ML (CAT NO 300850 MAKE B-D) 1 NO.
3 110354 TUBING PVC ID 2.8 mm X OD 4.3 mm 1 NO.
4 111213 TUBE TEFLON 0.75mm X 1.5mm (442-5409-4) 1 NO.
5 110194 TUBE TEFLON ID 1 mm OD 2 mm 1 NO.
6 110021 ASSEMBLY PERISTALTIC TUBE 1 NO.
7 110356 TUBING SILICON ID 2 mm OD 4 mm (IMPORTED) 1 NO.
8 110355 TUBE SILICON ID 0.8 mm X OD 2.4 mm 1 NO.

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OPTIONAL ACCESSORIES
1 111654 TopPette Adjustable Volume Pipette 5 - 50 Ul (720020) 1 NO.
2 TopPette Adjustable Volume Pipette 100 - 1000 Ul
111655 1 NO.
(720060)
3 110978 PIPETTE STAND (PLASTIC) 1 NO.
4 110943 PIPETTE TIPS SERIES 200UL YELLOW T200Y 100 NOS.
5 110944 PIPETTE TIPS SERIES 1000UL BLUE T1000B 100 NOS.
6 110001 INCUBATOR ASSEMBLY 1 NO.
7 111063 STAND TEST TUBE 1 NO.
8 110006 DEMO KIT 1 NO.

4.3. INSTALLATION REQUIREMENTS


The proper location is an important consideration; an improper location can lead to
malfunction of the analyzer. Please follow our environmental and electrical
suggestions to ensure the accuracy and precision of analyzer and to maintain high
level of safety for your personnel.
Since the analyzer is comparatively smaller, it can be comfortably accommodated
on any standard sized table.
Remember that minimum 30 cm. space is maintained between the rear panel and
the wall to allow for heat dissipation. The waste bottle should be placed on the
same level or below the level of analyzer.
Please ensure while taking any electrical measurement, the multimeter used must
have been calibrated and should possess valid calibration identification traceable
to National/International standard.
Also ensure that the power supply should be placed near to the analyzer in such a
way that ON/OFF switch is easily accessible to the user. This will help the user to
switch OFF the instrument immediately in case malfunctioning is detected.
PROBLEM resulting from the relocation of the analyzer done by
unauthorized service representative are not covered under warranty.

4.4. ELECTRICAL REQUIREMENTS


Voltage and Frequency Single phase continuous stabilized AC 110/230 V ± 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 3 Nos. of 5 Ampere outlet sockets should be available near the
installation 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’s etc., should not be
operated on the same electrical lines as the analyzer.

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4.5. 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 and check the output of the SMPS, it should be 18~24V DC ±
1V DC.
6. Connect the Peristaltic Pump tubing correctly and place the end of the
peristaltic pump tubing coming out of the analyzer into the waste bottle
provided for collecting the Waste.

4.6. PRINTER HOUSING AND PRINTER PAPER


INSTALLATION
4.6.1. INTERNAL PRINTER
There is a Thermal printer mounted inside the cabinet. It is extremely low noise
printer. The non-presence/improper installation (printer lever is not pressed
downward) of the thermal paper is detected and it is alarmed by 4 continuous
beeps.
Refer below Figure 1 for proper routing of Thermal Printer Paper roll.

NOTE: The thermal paper used must match the specification of the original one,
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.

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Operator Manual CHEM-7

4.6.2. EXTERNAL PRINTER


1. Switch off the analyzer before connecting printer.
2. HP DeskJet USB Printer can be attached to the analyzer to print reports,
graphs etc.
3. USB A Type connector is provided at the rear of the analyzer. Connect the
printer cable to this port before switching ON the analyzer.

4.6.3. PC COMMUNICATION
NOTE: USB Connectivity to PC requires operating system 2000/XP or above.

4.7. EXTERNAL KEYBOARD INSTALLATION


Switch off the analyzer before connecting PS2 keyboard. Then connect to the port
provided at the rear of the analyzer.

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5. PRINCIPLES OF OPERATION
5.1. MODES OF OPERATION
The analyzer is capable of performing analysis using the following modes.

5.1.1. ABSORBANCE MODE


The optical density in the range of 0 – 2.5 O.D. can be obtained directly on the
analyzer selecting appropriate wavelength.

5.1.2. ONE POINT LINEAR MODE


Results are directly obtained after the analyzer has been calibrated using a
standard /calibrator of known concentration. This mode is used for all routine End-
Point assays. You may even use the calibration factor in this mode.

5.1.3. TWO POINT LINEAR MODE


Two readings (one delta) at any fixed interval are used for the calculation of
results. 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. You may even use the calibration factor in this mode.

5.1.4. RATE A LINEAR MODE


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

5.1.5. SAMPLE BLANK LINEAR MODE


In this mode the concentration (End-Point) of the sample is obtained after sample
blanking. This mode is generally used for those test methods whose results are
greatly affected by Icteric, Lipemic or Hemolysed samples. Here sample
absorbance is obtained after subtraction of sample blank.

5.1.6. CONCENTRATION (NON-LINEAR) MODE


The concentration is obtained from a curvilinear graph, plotted by the analyzer
using a maximum of ten standards of increasing or decreasing concentrations
including zero standards (with concentration zero). This mode is useful for
Hormone assays.
The concentration (non-linear) mode is of the following types:
z One Point Non-Linear
z Two Point Non-Linear

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z Rate A Nonlinear
z Sample Blank Nonlinear

5.1.7. COAGULATION MODE


This mode is used for performing common Coagulation tests like Prothrombin
Time (PT) or Partial Thromboplastin (PTT) etc. The final result is obtained in
seconds.

5.2. READING THE CUVETTE


The internal volume of the flowcell is 18 μl. The flowcell holds the different reaction
mixtures whose absorbance, change in absorbance is to be measured. The
cuvette/flowcell is inserted inside a block, which is heated in metallic thermostat by
peltier effect. The light beam from the halogen lamp enters the transparent wall of
the flowcell and reads the absorbances of the solutions. 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:

5.3. CARRYOVER AND ASPIRATION VOLUME


Carryover is the influence of a solution, which has been flushed out from the
flowcell, on the absorbance readings of the solution that is aspirated next.
The major contributing factor to the carryover is the dead volume of the flow cell.
Flow cell volume is only 18 ȝl and hence the minimum recommended Volume for
Aspiration is 350 ȝl.

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In order to remove carry over effect completely, facility to aspirate air after each
aspiration is given. So after every aspiration, fixed 40μl air is aspirated by
peristaltic pump.
The aspiration volume is programmable from 200 – 999 ȝl.
For Rate A and Two Point mode, if the aspiration volume value is between 200-
399μl, extra 150 ȝl air is aspirated after displaying the result.
However, the Air Purge between samples is optional for the aspiration volume
range 400-999μL. It can be enabled/disabled from System Setup Menu.

5.4. 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 is measured at the end of the aspiration into
flowcell. Absorbance at the first reading is considered as the initial absorbance,
after the end of incubation, the actual readings starts; they 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 parameters “READ T” and “READ NUMBER” (TOTAL
READ.T = READ T * READ NUMBER).
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 is shown below.

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5.5. ADDITIONAL CUVETTE HOLDER


The analyzer’s main cuvette holder can accommodate 3 types of cuvette namely
the.
z 18 μl flowcell.
z Square Cuvette
z Round, reusable, 6 mm glass tube with adapter for coagulation
The analyzer is also provided with one Additional Cuvette Holder to hold the
Flowcell when either Square Cuvette or round glass is used as reading device in
the main cuvette holder.

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6. SETTINGS
6.1. PROGRAM MENU
Switch ‘ON’ the analyzer, it will automatically check all the important devices and
will show the status on display.
NOTE: It is mandatory to place the flowcell in main flowcell/cuvette holder while
switching ON the instrument or else all the photometer filters will be shown not ok
<X> in Hardware Check screen below.

If any of the parameter is not ok then we have to press <YES> to proceed. If any of
the photometer filters is found not ok i.e. <X> following screen will appear.

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If all the hardware tests are OK then the Home Screen will be displayed.

This screen is also referred to as the “Home screen” of the analyzer. This program
is used for the selection of test, programming of new codes, programming the date
and time, obtaining QC data, collated reports or running a self test.
Select any one of the options by pressing the dynamic key corresponding to the
desired option. Each sub-menu is described below.

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OTHER TESTS This key is used to select a test page by pressing the first letter of the
corresponding test name. For ease of operation, the assays are stored
alphabetically in 27 pages.
PARAMS This key is used to view direct access chemistry parameters.
Q. C. It checks the accuracy of sample analysis data from day to day. Specifically,
QC program consists of checking the accuracy and precision of analysis
(whether the same values are obtained when the analysis is repeated). Test
results can be memorized for 200 tests at 3 levels of controls for 31 days.
SYSTEM SETUP To set the laboratory information, system date, time and the data output
mode. For self-diagnostics test (self-test menu).
To view and edit Control values (Mean and SD) for 3 levels of controls at a
glance for the each chemistry.
To view and edit Normal minimum and maximum ranges for multiple Patient
types (Male/Female/Infant) at a glance for each chemistry.
REPORT Patient-wise report of all chemistries runs for a particular sample identified by
the following parameters.
ƒ Date.
ƒ ID.
ƒ Date and ID.
ƒ Date and Test name.
WASH When this key is pressed once, the peristaltic pump starts aspirating. If
pressed again the peristaltic pump stops aspiration. If the key is not pressed
again to stop washing it will stop automatically after aspirating approx. 5 ml
water.

6.2. SYSTEM SETUP


The system setup option allows the user to view, edit and print the system date,
time and the data output mode.
The “SYSTEM SETUP” screen is as follows:

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For “SELF TEST” Menu please refer to “Maintenance”.

6.2.1. SYSTEM PARAMETERS


To view or edit system parameters, press key <SYSTEM PARAMS> and following
screen will be displayed.

The dynamic keys <LAB INFO>, <SET DATE>, <SET TIME>, and < MODE> are
used to set the laboratory information, date, time and the data output mode
respectively.

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To use the above mentioned dynamic keys refer to the details given below.

6.2.1.1. LAB INFORMATION


Choose the option ‘<LAB INFO>’ from the System Parameter screen and the
following screen appears:
The user can enter laboratory information (25 characters each on 5 lines) with
external PC/AT keyboard as well as with unit keypad. This is stored in the memory.

The laboratory information is printed as header in Thermal and External Printouts.

6.2.1.2. SET 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 at the beginning
of the test or along with the Lab Header.
Choose the option <SET DATE> from the System Parameters screen and the
following screen appears.

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The cursor blinks at the first digit of the ‘Date’ option on the 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 year (from 00 to 99)
After appropriate entry is made, press the dynamic key <SAVE> to save date and
return to the system setup screen or press <QUIT> to quit without saving and
return to the system setup screen.

6.2.1.3. SET TIME


Choose the option <SET TIME> from the system setup screen and the following
screen appears.

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The cursor blinks at the first digit of the ‘Time’ option. 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
Again, a colon ‘:’ separates each entry sign, which appears automatically after the
entry of the 2nd digit.
After appropriate entry is made, press the dynamic key <SAVE> to save and
return to the system setup screen or press <QUIT> to quit without saving and go
back to the system setup screen.

6.2.1.4. MODE
Choose <MODE> on the system setup screen to set the data output mode.

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Five modes of output are available. Use the soft arrow keys to move between
selections and press <YES> or <NO> to select or deselect the options. Press <GO
BACK> to return to the system setup screen.
The results are printed on the analyzer’s thermal printer or external ‘hp’ make
deskjet printer or both printers as well as transmitted to the computer through the
USB interface.
BLANK DEDUCTION
If this is selected this will subtract Reagent Blank O. D. from all the test O. D. for all
modes of kinetic and 2 – point assays as well as for One point mode. If this is not
selected then Blank O. D. will be subtracted only for One point mode. This can be
selected or de-selected by pressing <YES> or <NO> respectively.
STD REPLICATE
Up to three replicates for the standard can be selected by using numeric keys. By
default it is one.
SAMPLE REPLICATE
Up to three replicates for the sample can be selected by using numeric keys. By
default it is one.
Air Purge
The user can select or deselect Air Purge option from this menu.
For Rate A and Two Point mode, Air Purge must be enabled if aspiration volume is
less than 400ȝl.

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However, Air Purge is optional if the aspiration volume value is between 400 –
999μl.
If Air Purge is enabled extra 150 ȝl air is aspirated after displaying the result.
If Air Purge is disabled, extra 150 ȝl air is not aspirated.

6.2.2. CONTROL DATA


Press key <CNTRL DATA> from SYSTEM SETUP menu to view and edit control
MEAN and SD values of all 3 levels (C1/C2/C3) for each chemistry. This menu will
enable the user to view and edit Control values at a glance.
The screen displayed is as follows.
Key <TESTS> if pressed, displays test names one by one consecutively and also
Control values are displayed.

6.2.3. NORMAL RANGES


Press key <NORMAL DATA> from SYSTEM SETUP menu to view and edit
NORMAL MINIMUM and MAXIMUM ranges of all 3 sample types
(Male/Female/Infant) for each chemistry. This menu will enable the user to view
and edit Normal Ranges at a glance.
The screen displayed is as follows.
Key <TESTS> if pressed, displays test names one by one consecutively and also
Normal Ranges are displayed.

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6.2.4. CALCULATION ITEMS


Press dynamic key <CALC ITEMS> from SYSTEM SETUP menu to calculate
certain parameters from the previously run chemistry results. The screen displayed
is as follows.

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List of calculation items can be seen after entering a valid sample ID.
Analyzer provides 5 formulae for recalculation which are:
z A+B
z A -B
z (A – B) * a + b
z (A / B) * 100
z (A / B ) * e * (f / 1440)
NOTE: In the above formulae, A and B are test names.
a and b are user defined constants.
e is the Body Mass Index (calculated from height and weight of patient)
f is the urine volume collected in 24 hours.
(e and f are used to calculate Creatinin Clearance)
Press key <I.D.> to enter sample ID. Enter valid ID and then select the Equation
By pressing key <EQU.>

Select the Calculation Item (equation) and press <ENTER> to confirm.


Select a test for which a result is obtained before. Use key <TESTS> to select A
test and key <PARAMS> to toggle between the equation parameters before
entering the constant values or the pre calculated test result.

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After entering all the parameters of the equation, press key <CALC> to calculate
the result.

6.3. ANALYSIS CODE GENERATION


The analyzer is preprogrammed for analysis codes. The analysis code for any
chemistry can be created, changed or viewed by the operator. An analysis 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 (vacant positions are identified by an “****“code). To
set the analysis code, choose any one of the appropriate pages using the alpha
numeric keys A to Z.
E.g. To select a test beginning with the alphabet ‘B’ the alpha numeric key B.
Similarly, to select a test beginning with the alphabet ‘L’ the alpha numeric key L
has to be pressed.

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After this screen appears press the dynamic key ‘< ENTER >’ so that the numbers
are displayed along with the test name as shown below:

Press the number corresponding to the test to select the test.

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Press the dynamic key < ENTER CODE > is used to change or edit the test code
and its description. On pressing the dynamic key ‘< ENTER CODE >’ the display
will appear as follows.

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After confirming the name of the analysis code using <ENTER>, the user can
further change the code, change parameter or perform a run test using the
dynamic keys <ENTER CODE>, <PARAMS> and <RUN TEST>
On pressing the dynamic key <PARAMS> the parameters for the selected test can
be viewed. Setting of parameters is discussed in detail in following section.
To run the selected test, press the dynamic key <RUN TEST>.

6.4. SETTING OF PARAMETERS


After the analysis codes for all the chemistries are set, the parameters for the each
chemistry will have to be entered. To set the parameters select the analysis code /
test by pressing the appropriate number key and then press the dynamic key
<PARAMS>.
The display will show all the parameter heads concerning the selected analysis,
with the cursor at the beginning of the page. Using the numeric keys all the
parameters of the chemistry is to be set. The cursor can be shifted to the required
position using the arrow keys.
Following is an example of main parameters of ALB in the Rate A mode.

Use the dynamic arrow keys to select the required parameter. Predefined values
for the selected parameter are displayed in a ‘Help Menu Box’ on the screen. The
numbers in the box corresponds 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.

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

6.5. PARAMETER DEFINITIONS AND VALUES


MODE (N.): 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 O.D.).
Key ‘1’ - 1 – POINT - For linear end-point chemistries.
Key ‘2’ - 2 - POINT - For linear fixed time chemistries.
Key ‘3’ - RATE A - For linear kinetic chemistries.
Key ‘4’ - 1_PT_NL - For non-linear endpoint chemistries.
Key ‘5’ - 2_PT_NL - For nonlinear fixed time calibration.
Key ‘6’ - RATE_NL - For nonlinear kinetic chemistries.
Key ‘7’ - COAG - For Coagulation mode (gives time in sec.)
Key ‘8’ - SAMP_BK - For sample Blank Mode
Key ‘9’ - SAMP_BK_NL - For Sample Blank Nonlinear mode
FILTER 1: It is the primary filter at which measurements are made. The available
wavelengths are: 340, 405, 450, 505, 546, 578, 600, and 670 nm, eight filter
wavelengths are available which can be chosen from the Help menu box on the
screen, using the numeric keys 1 through 8.
Key ‘1’ - 340nm
Key ‘2’ - 405nm
Key ‘3’ - 450nm
Key ‘4’ - 505nm
Key ‘5’ - 546nm
Key ‘6’ - 578nm
Key ‘7’ - 600nm
Key ‘8’ - 670nm
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. Eight filter wavelengths are available which can be
chosen from the ‘Help Menu’ box using the numeric keys 0 through 8.
Key ‘0’ - No filter

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Key ‘1’ - 340nm


Key ‘2’ - 405nm
Key ‘3’ - 450nm
Key ‘4’ - 505nm
Key ‘5’ - 546nm
Key ‘6’ - 578nm
Key ‘7 ’- 600nm
Key ‘8’ - 670nm
FACTOR: It is a value ranging from 0 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 values manually also; at this field decimal
key is functional.
STANDARD CONCENTRATION: It is a value ranging from 0 to 99999 according
to concentration of the standard used in the calibration of the test.
NOTE: The Standard value can be set to 0 when a predetermined or calculated
factor is used (see paragraph about concentration readings). The decimal point
can be inserted in the figure using ‘.’ Key provided on the soft keypad. For
example 3.0, 30.0.
NORMAL MINIMUM: Minimum range of the concentration for the normal sample.
(This range is given for Male, Female and Infant patient types and can be viewed /
edited with key <M/F/I>)
NORMAL MAXIMUM: Maximum range of the concentration for the normal sample.
(This range is given for Male, Female and Infant patient types and can be viewed /
edited with key <M/F/I/off >.) If off option is selected in the run test menu the result
is directly printed.
TEMPERATURE: Temperature can be entered in the range 20q to 40qC.
DELAY TIME: This is the incubation time in seconds which can be entered in the
range 5 – 999 seconds.
READ TIME: This is the reaction time in seconds which can be entered in the
range 5 – 999 seconds.
READ NUMBER: Actual reaction time taken is the product of Read Time and
Read Number. Read Number can be entered in the range 5 – 999 seconds.
REACTION DIRECTION : This parameter indicates the reaction direction Help
menu for this parameter shows the following options
0 - > INC (increasing) 1 -> DEC (decreasing)
Concentration calculated at the end is multiplied internally by (-1) if reaction
direction is decreasing and by (1) if it is increasing.

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REAGENT ABSORBANCE LIMIT: This is the maximum absorbance limit for


reagent, if it is an increasing reaction and minimum absorbance limit for
decreasing reaction.
Error message ‘Critical Reagent Absorbance’ is given if the limit is crossed.
Range is 0 – 2.5 absorbance.
REACTION ABSORBANCE LIMIT: It is a value ranging from 0 to 2.5. Absorbance
limit is that absorbance at which the substrate depletion is detected.
If the reaction direction is increasing, it is higher limit.
If the reaction direction is decreasing, it is lower limit
Every test result, for which these limits are violated, is reported with flag ‘RX ABS
LIM OVER’ or ‘RX ABS LIM UNDER’ depending on the type of reaction.
LINEARITY LIMIT: It is linearity of reagent kit. It is to be entered in terms of
concentration which ranges from 0 to 99999. The parameter is useful to reveal a
Hyperactive Sample.
The photometer performs the measurement and gives error message
‘HYPERACTIVE SAMPLE’ along with test result if the sample has shown a higher
concentration than the parameter that has been set and this would be an indication
that the sample has to be diluted and re-assayed.
UNIT: 24 different units are possible with the help of key <UNITS> and <1> to
<9>numeric key.
(1 page of units is seen at a time and pressing <UNITS> will toggle through three
unit screens)
Page 1:
1 – mg/dl 2 – IU/L 3 – mEq/L 4 – g/L
5 – g/dl 6-% 7 – mIU/L 8 – mIU/ml 9 – ng/ml
Page 2:
1 – ug/dl 2 – ng/dl 3 – mg/L 4 – ug/L
5 – ng/L 6 – IU/ml 7 – umol/L 8 - mmol/L 9 – ug/ml
Page 3:
1 – uIU/ml 2 – mmol/ml 3 – umol/ml
4 – nmol/L 5 – pmol/L 6 – uIU/L
7 – mg/ml 8 – U/L 9 – uKat/L
Unit ABS for Absorbance mode and unit SEC for Coagulation mode are
automatically applied when these modes are selected.

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SAMPLE VOLUME (μl)


This volume helps the operator in pipetting correct volume of Sample. The range is
0.1 – 999 μl.
REAGENT 1 VOLUME (μl)
This volume helps the operator in pipetting correct volume of Reagent1. The range
is 5 – 999 μl.
REAGENT2 VOLUME (μl)
This volume helps the operator in pipetting correct volume of Reagent2. The range
is 5 – 999 μl.
ASPIRATION VOLUME (μl)
It is a value ranging between 200 to 999 ȝl and represents the volume of the
solution to be aspirated into the flow cell.
For Rate A and Two Point mode, if the aspiration volume value is between 200 to
399μL, Air Purge must be enabled.
Air Purge can be enabled/disabled from System Setup Menu.
With the flow cell capacity being 18 ȝl, a minimum 350 ȝl volume is recommended
to eliminate errors due to carry over.
C MEAN:
It is the target value of the control ranging from 0 to 99999 for a particular test.
Mean value for Control 1 is displayed by default. Key <CNTRL> can be used to
view values for Control 2 and Control 3.
C SD:
This is the preset Standard Deviation range of the control. Standard deviation
value for Control 1 is displayed by default. Key <CNTRL> can be used to view
values for Control 2 and Control 3.
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. Enter an appropriate data
and press the dynamic <RUN TEST> key to start the test.

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This Page is Intentionally Left Blank

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7. MODES OF OPERATION
Refer chapter 5 for test parameters before performing any TEST.

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

2. Aspirate DI water. The absorbance on the display will be set to “0”.


3. Select any 6 digit alphanumerical code for I.D. number of patient using any
of the alphanumeric keys.
4. Aspirate the test solution to determine its absorbance. The display will
directly give the absorbance of the sample.
5. Press the dynamic key <CNTRL>to run the control sample. The Patient I.D.
changes to “C1”, “C2” or “C3” as per the selection.
6. Press the dynamic key <READ> if the absorbance is to be measured using
Polystyrene cuvette.

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7. An automatic printout is obtained if “AUTOPRINTOUT” output mode is


selected in the system setup. If not, the dynamic <PRINT> key can be used
to get a printout.
8. Aspirate other test solutions one after the other to obtain OD. Absorbance
readings ranging from 0 to 2.5 can be obtained on this analyzer.
9. After all readings are taken, press < RESET > key to exit the test or press
direct access key of another test to be performed next. If direct access key
of another test is pressed following screen will appear:

10. When the display changes to the “Home screen” wash the flowcell, using
the <WASH > (follow instructions on the display).
11. The <READ PERIOD> helps the user to enter a time period from 1 to 999
min during which the readings can be taken at the interval of 10sec.
NOTE: Since the aspiration by the peristaltic pump automatically clears the
previous solution, it is not necessary to wash between the samples. This applies to
all modes of operation.

7.2. 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 by the analyzer after
multiplying the absorbance value with a factor, which was previously obtained
during calibration.

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The operational steps are as follows:


Refer chapter 5 to perform “RUN TEST”.
1. The parameters necessary for operation in the mode are as displayed on
the screen.
2. When the analyzer displays “ASPIRATE WATER”: Aspirate DI water and
wait for a few seconds (The analyzer automatically zero’s the O.D.).
3. Aspirate the Reagent Blank when the analyzer displays “ASPIRATE
REAGENT BLANK” and wait for a few seconds. The O.D. of the Reagent
Blank is automatically stored in the memory of the analyzer and for all
subsequent readings; this O.D. is subtracted to obtain a final O.D. of
reaction mixture. There is an option to skip reagent blank aspiration by
pressing dynamic key <NO>. In this case, memorized blank O.D. is used for
calculation.
4. The analyzer displays “ASPIRATE STANDARD”. If there are replicates
defined in system parameters, prompt will be displayed as “ASPIRATE STD
REPL 1” and so on. Aspirate standard solution (RGT + STD). Wait for a few
seconds, to allow the solution to stabilize in the flowcell. The analyzer
displays the absorbance of the Standard Solution and if all replicates are
not yet aspirated, asks for next replicate. If all replicates are aspirated,
factor is calculated and memorized. The factor obtained is now displayed
against the FACTOR on the Screen. There is an option to skip standard
solution aspiration by pressing dynamic key <NO>. In this case, memorized
factor is used for calculation. This test can be performed by entering factor
predefined in test parameters.

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5. Perform samples, while the analyzer is prompting “ASPIRATE SAMPLE” or


“ASPIRATE SAMPLE REPL1” in case of 2/3 replicates. On pressing the
key, I.D. The alphanumeric sample I.D. can be entered. To perform the
sample run press I.D. key again. I. D. changes to C1/C2/C3 on screen when
<CNTRL> key is pressed followed by “ASPIRATE CONTROL” prompt.
The analyzer will automatically start incubation countdown (entered as
Delay time in parameters). At the end of delay time the analyzer will give the
absorbance.
6. Aspirate other test solutions one after another.
7. Concentration is calculated when all replicates are aspirated. Net OD
displayed is the OD obtained after subtracting reagent OD and it is the
average of all replicates aspirated. User has to enter sample type (Male /
Female / Infant) to give the flag as per the normal ranges for each type. If
off option is selected in the test parameters then the result is directly printed
8. The display will show the absorbance as well as the concentration of each
sample and a printout of the result is obtained either automatically or by
using the dynamic <PRINT> key.
9. After all readings are taken, press the <RESET> key to return to the “Home
Screen” or press direct access key of another test to be performed next. If
direct access key of another test is pressed, following message will appear
“PLEASE RINSE THE FLOW-CELL WITH DI WATER”. When the display
changes to the “Home Screen”/RUN TEST Screen of another test, wash
the flowcell, using the dynamic key < WASH >.
NOTE: If the factor is already memorized, on aspirating reagent blank or
standard solution, the existing factor as well as the new factor are displayed
on the screen and the user can opt for new factor by pressing dynamic key
<YES> or retain the old factor by pressing dynamic key <NO>.
NOTE: Dynamic key < READ > can be used to read a sample from the polystyrene
cuvette.

7.3. 2-POINT LINEAR MODE


The 2-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 a factor.

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1. The parameters necessary for operation are displayed on the screen.


2. Aspirate de ionized water when the analyzer displays “ASPIRATE
WATER”. The analyzer automatically zeros the O.D.
3. Aspirate the Reagent Blank when the analyzer displays “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 read time countdown. There is an option to skip
reagent blank aspiration by pressing dynamic key <NO>. In this case,
memorized delta blank O.D. is used for calculation.
4. The delta O.D. of the Reagent Blank is automatically stored in the memory
of the analyzer and for all subsequent readings, this delta O.D. is subtracted
to obtain a final delta O.D. of reaction mixture if reagent blank deduction is
opted in test parameters. The graphical representation of the reaction is
displayed on the screen. The printout of result and graph can be obtained
by pressing the dynamic <PRINT > key. Printout of the graph can be taken
by pressing <PRINT> key again.
5. The screen displays “ASPIRATE STANDARD” or “ASPIRATE STD REPL
1” if there are replicates. Aspirate Standard solution (RGT + STD). The
analyzer will automatically start incubation countdown (entered as Delay
time in parameters) followed by the Read time countdown for “1” reading.
There is an option to skip standard solution aspiration by pressing dynamic
key <NO>. In this case, memorized factor is used for calculation. This test
can be performed by entering factor predefined in test parameters.
6. When the screen displays “ASPIRATE SAMPLE” (“ASPIRATE SAMPLE
REPL1” in case of replicates defined) the alphanumeric sample I.D. can be

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entered on pressing the key, I.D. To perform the sample run press I. D. key
again. Aspirate Reaction mixture (RGT + SMP). The analyzer will
automatically start incubation countdown (entered as Delay time in
parameters) followed by the Read time countdown. Concentration/activity is
calculated when all replicates are aspirated. Net delta OD displayed is the
delta OD obtained after subtracting reagent delta OD and it is the average
of all replicates aspirated. User has to enter sample type (Male / Female /
Infant/) to give the flag as per the normal ranges for each type. If off option
is selected in the test parameters then the result is directly printed.
7. To perform control samples, press dynamic key <CNTRL> while the
Analyzer is prompting “ASPIRATE SAMPLE”. On pressing the key, I.D
changes to C1/C2/C3 on screen with “ASPIRATE CONTROL” prompt. The
analyzer will automatically start incubation countdown (entered as Delay
time in parameters) followed by the Read time countdown.
8. After analyzing all the samples, press < RESET > key to return to the
“Home screen”; or press direct access key of another test to be performed
next. If direct access key of another test is pressed, following message will
appear “PLEASE RINSE THE FLOW-CELL WITH DI WATER”.
9. When the display changes to the “Home Screen”/ RUN TEST Screen of
another test, wash the flowcell, pressing the dynamic key <WASH>.
The graphical representation is as shown below:

NOTE: If the factor is already memorized, on aspirating reagent blank or standard


solution, the existing factor as well as the new factor are displayed on the screen

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Operator Manual CHEM-7

and the user can opt for new factor by pressing dynamic key <YES> or retain the
old factor by pressing dynamic key <NO>.

7.4. RATE A LINEAR MODE


Most enzyme chemistries are performed using this mode.

The operational steps to perform a kinetic test are as follows:


1. The parameters necessary for operation are displayed on the screen.
2. Aspirate DI water when the analyzer displays “ASPIRATE WATER”. The
analyzer automatically zero’s the O.D.
3. Aspirate the Reagent Blank when the analyzer displays “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 read time countdown. There is an option to skip
reagent blank aspiration by pressing dynamic key <NO>.
4. The delta O.D. per minute of the Reagent Blank is automatically stored in
the memory of the analyzer and for all subsequent readings, this delta O.D.
per minute is subtracted to obtain a final delta O.D. per minute of reaction
mixture, if reagent blank deduction is opted in test parameters. The
graphical representation of the reaction is displayed on the screen. The
printout of result and graph can be obtained by pressing the dynamic
<PRINT> key.
5. Kinetic chemistries are usually performed using a predetermined factor. The
factor is provided by the reagent manufacturer.

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NOTE: In case, calibration is opted, make sure that concentration of


standard/calibrator is entered in the test parameters and then proceed for
calibration as follows.
Aspirate Standard solution (RGT +calibrator) when the screen displays
“ASPIRATE STANDARD”. The analyzer will automatically start incubation
countdown (entered as delay time in parameters) followed by the read time
countdown. Factor is calculated by this standard.
6. Enter an appropriate sample ID using alphanumeric keys provided on the
keypad if desired.
7. Aspirate reaction mixture (RGT+ Sample) when “ASPIRATE SAMPLE” or
“ASPIRATE SAMPLE REPL 1” message, the analyzer will automatically
start incubation countdown (fed as Delay time in parameters) followed by
the read time countdown. Real time O.D. is displayed on the screen as the
reaction proceeds.
The total time required for a kinetic assay is calculated as:
TOTAL TIME = DELAY TIME + (READ TIME * READ NUMBER) When all
the replicates are aspirated, delta sample od/m is calculated with Linear
regression method and sample concentration is calculated.
Net OD displayed is average OD from which reagent OD is subtracted if
blank Deduction option is selected.
8. The end of the reaction is signaled by a beep and the result and the
graphical representation of the reaction is displayed on the screen. User
has to enter sample type (Male / Female / Infant/off) to give the flag as per
the normal ranges for each type. If off option is selected in the test
parameters then the result is directly printed. The printout of result and
graph can be obtained by pressing the dynamic <PRINT>.
The graph is seen on the screen and the printout of graph can be obtained
by pressing the dynamic <PRINT> key again.
9. Press <ASP> switch to aspirate the next sample and wait for the result.
10. To perform control samples, press dynamic key <CNTRL> while the
analyzer is prompting “ASPIRATE SAMPLE”. On pressing the key, I.D.
changes to C1/C2/C3 on screen with “ASPIRATE CONTROL” prompt. The
analyzer will automatically start incubation countdown (entered as Delay
time in parameters) followed by the Read time countdown.
11. After analyzing all the samples, press the < RESET > key to exit this screen
or press direct access key of any test to run that test. If direct access key of
another test is pressed, following message will appear “PLEASE RINSE
THE FLOW-CELL WITH DI WATER”.
12. When the display changes to the “Home screen” wash the flowcell, using
the “ASP” switch (follow the instructions on the display.

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NOTE: If the factor is already memorized, on aspirating reagent blank or


standard solution, the existing factor as well as the new factor are displayed
on the screen and the user can opt for new factor by pressing dynamic key
<YES> or retain the old factor by pressing dynamic key <NO>.
The graphical representation is as shown below.

NOTE: After display of the result a prompt will appear Press <-/.> for recalculation
of the result .This facility can be used to recalculate the result if flag of hyperactive
sample or Rx Abs lim under/over flag is displayed.
The delay time should be equal to or greater than the value fed in test parameter.
If a greater value of delay is fed the total of delay and read time should not exceed
the total of two fed in the test parameters

7.5. 1-POINT NON LINEAR MODE


There are some chemistries which require multilevel standards for calibration. The
sample absorbance may not be 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. The display shows the following screen:

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2. To begin the procedure for curve calibration, press the dynamic key <
CALIB > The calibration table is seen on the display is as follows.

3. Using up/down and left/right arrow keys and the numeric keys enter the
concentration of the standards to be run. A minimum of 3 and a maximum
of 10 standards can be used. Once the required values are entered, press
< SAVE > to save the values into the memory. The date and time at which
the calibration table is modified, is also stored and displayed every time
along with the calibration table.

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NOTE: 1-Point non-linear mode can be performed by directly entering the


absorbance values and concentration of the standards in the calibration
table. Press the dynamic < GO BACK > key to go back to the previous
screen and then the dynamic key < SAMP> for sample run. To run full
calibration, minimum 3 nos. of concentration and absorbance of standards
must be entered.
4. Press the dynamic key < CALIB > and choose one of the options for
calibration.

Full Calibration: Press the dynamic key < FULL CALIB > to choose this
option.
The screen changes to as shown on next page:

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a. When the analyzer displays “ASPIRATE WATER” aspirate di-ionized


water and wait for a few seconds. (The analyzer automatically zero’s the
O.D.)
b. Aspirate standard when the analyzer displays “ASPIRATE STANDARD”
(or “ASPIRATE STD REPL1” if replicates are set) & wait for the
absorbance reading to stabilize and then enter the corresponding
number of the standard using the numeric keys.
c. Repeat step ‘b’ for all standards in sequential order.
d. After all the standards have been aspirated, press the dynamic <GO
BACK> key to stop setting. The display returns to the calibration table
screen. Press the dynamic <GO BACK> key once again to return to the
Non-Linear Test screen.
e. Push the dynamic < GRAPH > key to verify the interpolation curve.
Display of the graph will be seen on the screen. ‘Please Wait’ is
displayed during plotting of the graph.
f. The statistical procedure used to elaborate the curve is based on the
method of point-to-point, cubic spline or Logit Log interpolation, which
can be selected by pressing dynamic key <METHOD>.
g. To get a printout of the curve press the dynamic key < PRINT >.
h. This is the end of the calibration procedure. The curve obtained is stored
in memory of the analyzer till recalibration is performed.
i. To run a sample, go back to the Non-linear test screen and press the
dynamic < SAMP > key. Enter an appropriate sample ID using
alphanumeric keys provided on the keypad if desired.

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j. To perform control samples, press dynamic key <CNTRL> while the


analyzer is prompting “ASPIRATE SAMPLE”. On pressing the key,
k. I.D. changes to C1/C2/C3 on screen with “ASPIRATE CONTROL”
prompt. The analyzer will automatically start incubation countdown
(entered as Delay time in parameters) followed by the Read time
countdown.
l. Aspirate the samples sequentially and the analyzer will give the results
Interpolated directly from the previously plotted graph using the
absorbance read by the photometer. User has to enter sample type
(Male / Female / Infant) to give the flag as per the normal ranges for
each type. If off option is selected in the test parameters then the result
is directly printed.

SELECT POINT: dynamic key < SELECT POINT> facilitates the user for
selecting/ deselecting the points which are appropriate / inappropriate. By
default all the points are selected and the graph plotted is of all the points.
To deselect a point, go to the undesired point using dynamic <up> or
<down> arrow key and press dynamic key <NO>.
The screen is shown on the next page.

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If user opts for Gain Calibration only one standard is run and the entire
curve is plotted based on the ratio of new factor to the old factor of the
particular standard.
If user opts for Offset Calibration only one standard is run and the entire
curve is plotted based on the difference between new absorbance and old
absorbance of the particular standard.
After analyzing all the samples, press the < RESET > key to exit this screen
or press direct access key of any test to run that test. If direct access key of
another test is pressed, following message will appear “PLEASE RINSE
THE FLOW-CELL WITH DI WATER”.
When the display changes to the “Home screen” wash the flowcell, using
the “ASP” switch (follow the instructions on the display).

7.6. 2-POINT NON LINEAR MODE


The operational steps are as follows when calibration has to be performed:
1. When key <RUN TEST> is pressed , the screen will be displayed which is
similar to the screen shown in section 6.5 (for one point non linear mode)
2. To begin the procedure for curve calibration, press the dynamic key <
CALIB TABLE>. The calibration table is seen on the display is as shown on
next page:

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3. Using the vertical cursors Ð Ï and the numeric keys enter the
concentration of the standards to be run. A minimum of 3 standards should
be used.
NOTE: 2-Point non-linear mode can be performed by directly entering the
delta absorbance values of the standards and Concentration in the
calibration table. Press the dynamic key <GO BACK> to go back to the
previous screen and then the dynamic < SAMP > Key for sample run. To
run full calibration, minimum 3 nos. of concentration of standards and Abs
must be entered.
a. Press the dynamic key <CALIB> and choose one of the options for
calibration.
b. Aspirate de ionized water when the analyzer displays “ASPIRATE
WATER”. The analyzer automatically zero’s the O.D.
c. Aspirate Standard solution when the screen displays “ASPIRATE
STANDARD”.
d. The analyzer will automatically start incubation countdown (entered as
Delay time in parameters) followed by the Read time countdown for “1”
reading.
e. When the result is displayed on the screen enter the corresponding
number of standard using the numeric keys.
4. Repeat step 8 for all standards in sequential order. Further procedure is
same as described in the 1-Point Non Linear Mode from steps e. to l.
5. After analyzing all the samples, press the < RESET > key to exit this screen
or press direct access key of any test to run that test. If direct access key of

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another test is pressed, following message will appear “PLEASE RINSE


THE FLOW-CELL WITH DI WATER”.
6. When the display changes to the “Home screen” wash the flowcell, using
the “ASP” switch (follow the instructions on the display).

7.7. RATE A NON LINEAR MODE


Please refer to the procedure for 2-Point Non Linear Mode.

7.8. 1-POINT LINEAR WITH SAMPLE BLANK

The operational steps are as follows:


1. When the analyzer displays “ASPIRATE WATER” aspirate de-ionized water
and wait for a few seconds. (The analyzer automatically zero’s the O.D.)
2. Aspirate the reagent blank when the analyzer displays “ASPIRATE
REAGENT” and wait for a few seconds. The O.D. of the reagent blank is
automatically stored in the memory of the analyzer and for all subsequent
readings; this O.D. is subtracted to obtain a final O.D. of reaction mixture.
There is an option to skip reagent blank aspiration by pressing dynamic
key <NO>.
3. Aspirate standard blank solution when the analyzer displays “ASPIRATE
STANDARD BLANK” or “ASPIRATE STD BLK REPL1” if there are more
replicates. The analyzer displays absorbance of the standard blank. There
is an option to skip standard blank aspiration by pressing dynamic key
<NO>. On pressing <NO>, the analyzer will skip step 4 and display will
prompt to “ASPIRATE SAMPLE BLANK”.

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4. Aspirate standard solution (RGT + STD), when the analyzer displays


“ASPIRATE STANDARD” or “ASPIRATE STD REPL 1” and wait for a few
seconds, to allow the solution to stabilize in the flowcell. The analyzer
displays the absorbance which is obtained by subtracting standard blank
absorbance from standard absorbance. The new factor is memorized which
is displayed against the FACTOR on the Screen.
Enter patient I.D. using alphanumeric keys to run patient samples or press
the dynamic key <CNTRL> to run the control sample. The Patient I.D.
changes to “C1”,”C2” or “C3” as per the selection.
5. Aspirate Sample Blank or Control Blank when the display shows
“ASPIRATE SAMPLE BLANK” or “ASPIRATE CONTROL BLANK” or if
there are more than 1 sample replicates, the message displayed will be
“ASPIRATE SAMP BLK REPL 1” After this aspirate sample or control when
the display shows “ASPIRATE SAMPLE”, “ASPIRATE CONTROL” or
“ASPIRATE SAMP REPL 1” .
Sample blank/ control blank O.D. is subtracted from Sample/ control O.D.
respectively.
6. The display will show the net absorbance, which is obtained after
subtracting sample blank absorbance and reagent absorbance.
Concentration is calculated and displayed. Printout of the result is obtained
either automatically or by using the dynamic < PRINT > key after entering
sample type.
7. After all readings are taken, press the < RESET > key to return to the
“Home screen” or press direct access key of any test to run that test. If
direct access key of another test is pressed, following message will appear
“PLEASE RINSE THE FLOW-CELL WITH DI WATER”.
8. Wash the flowcell with DI water, and follow the instructions on the display.

7.9. 1-POINT NON-LINEAR WITH SAMPLE BLANK


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 1-Point Non-linear Sample Blank mode is
selected and press < ENTER >.

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2. To begin the procedure for curve calibration, press the key < CALIB >.
Using the cursors and the dynamic keys enter the concentration of the
standards to be run. A minimum of 3 and a maximum of 10 standards can
be used. Press < CALIB > key to measure the actual absorbance of the
standards. Enter appropriate standard number to save the absorbance
against the aspirated standard.
The calibration table seen on the display is as follows:

3. Press < CALIB > key followed by the < FULL CALIB > key.

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4. Aspirate de ionized water when the analyzer displays “ASPIRATE WATER”


5. The analyzer automatically zero’s the ABS.
6. Aspirate the Standard Blank solution when the screen displays “ASPIRATE
STD BLANK”. The analyzer will automatically start Incubation countdown
(entered as delay time in parameters) and the ABS is displayed on the
screen. If there are more replicates, the prompt displayed will be
“ASPIRATE STD BLK REPL 1”
7. Aspirate the standard solution when “ASPIRATE STANDARD” or
“ASPIRATE STD REPL1” as per the number of standard replicates
selected.
8. Net absorbance will be displayed which is obtained after subtracting
standard blank absorbance from standard absorbance. Enter the standard
number so that this absorbance is stored as the absorbance of the standard
aspirated.
9. Repeat step 5 to 7 for all standards in sequential order.
10. After all the standards have been aspirated the display returns to the
calibration table screen and displays the updated values. Press the <GO
BACK> key to return to the Non-Linear test screen.
11. Press the dynamic key <GRAPH> 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 Point to point, cubic
spline or Logit log interpolation.

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12. 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.
13. To run a sample, go back to the Non Linear Test Screen and press the
dynamic key < SAMPLE >.
14. Aspirate water when “ASPIRATE WATER” is displayed on the screen.
15. When the screen displays “ASPIRATE SAMPLE BLANK” or “ASPIRATE
SAMP BLK REPL1” if there are more replicates. Enter appropriate patient
ID if required. Aspirate sample blank solution. The analyzer will
automatically start incubation countdown (entered as Delay time in
parameters) at the end of delay time the analyzer will give the absorbance.
16. When the screen displays “ASPIRATE SAMPLE” or “ASPIRATE SAMP
REPL1” Aspirate reaction mixture. The analyzer will automatically start
incubation countdown (entered as Delay time in parameters). At the end of
delay time the analyzer will give the result interpolated directly from the
previously plotted graph using the net absorbance measured by the
photometer.
17. To perform control samples, press dynamic key <CNTRL> while the
analyzer is prompting “ASPIRATE SAMPLE BLANK”. On pressing the key,
I.D. changes to C1/C2 or C3 on screen with “ASPIRATE CONTROL
BLANK” prompt. The analyzer will automatically start incubation countdown
(entered as Delay time in parameters). At the end of delay time the analyzer
will give the absorbance.
18. When the screen displays “ASPIRATE CONTROL”. Aspirate reaction
mixture. The analyzer will automatically start incubation countdown (entered
as Delay time in parameters) at the end of delay time the analyzer will give
the result interpolated directly from the previously plotted graph using the
net absorbance measured by the photometer. If in the thermal printer is
activated then the result will be printed automatically after selection of the
gender of the patient, otherwise user has to press < PRINT > switch.
19. After analyzing all the samples, press the < RESET > key to exit this screen
or press direct access key of any test to run that test. If direct access key of
another test is pressed, following message will appear “PLEASE RINSE
THE FLOW-CELL WITH DI WATER”.
20. When the display changes to the “Home screen” wash the flowcell, using
the “ASP” switch (follow the instructions on the display).

7.10. COAGULATION MODE


For performing coagulation select tests like Prothrombin Time (PT) or Partial
Thromboplastin Time (PTT).
The screen will appear as follows.

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1. User should replace the flowcell with specially provided aluminum holder
and use the glass tubes (6.0 mm light path).
2. Add desired sample (usually 0.1) in the tube.
3. Press < INCUB > for incubation.
4. Analyzer will start incubation countdown entered as delay time in
parameters. (In one reagent chemistry, READ TIME will be set to 0 whereas
in two reagent test, READ TIME field should have some value).
5. After the incubation is over the screen will appear as follows.

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6. Add reagent in a tube and press <START>. 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. If it is two reagent test,
at the click on <START>, the countdown starts for read time. At the end of
this time, two beeps are given and user is prompted to add the second
reagent and click on <START> to start coagulation.

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7. The H/L flagging will be given with reference to N.V.MIN and N.V.MAX.
values which are fed in parameters.
For PT (Prothrombin Time) test there is a facility to calculate INR value i.e.
International Normalized Ratio.
Press < INR > to print the result in INR which is calculated as:

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


FACTOR is the International Sensitivity Index (ISI).
8. After analyzing all the samples, press the < RESET > key to exit this screen
or press direct access key of any test to run that test. If direct access key of
another test is pressed, following message will appear “PLEASE RINSE
THE FLOW-CELL WITH DI WATER”.
9. When the display changes to the “Home screen” wash the flowcell, using
the “ASP” switch (follow the instructions on the display).

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This Page is Intentionally Left Blank

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Operator Manual CHEM-7

8. REPORTS
8.1. QUALITY CONTROL
Quality control of a calibrated biochemistry analyzer is the periodic monitoring of
the system performance by use of specimens both in the normal and abnormal
range for comparison. The obtained data is compared with previously obtained
data. A variety of QC materials are available for this use.
The analyzer can store data of 3 levels of controls for 31 days, for all the 200 tests.
The target value and the 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 the each chemistry 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. Total 5 values for each test per control per day can be stored in the
analyzer.
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 number & expiry of each vial.

8.1.1. QUALITY CONTROL SCREEN


Results for each specimen run when a particular chemistry is selected are
automatically stored in that chemistry file. Results for the 200 tests are available at
all times. All QC file stored data are available for operator review on a printer
output.
The number appear adjacent to the analysis codes after pressing ‘ENTER’ in the
<Q.C> screen as shown below.

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Press the appropriate number key to select the required analysis code, and then
press ENTER.

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Operator Manual CHEM-7

The display changes to the following screen.

8.1.2. 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 the 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/C3) run for the
day.
Daily Quality Control Report for C1/C2/C3:
After the pressing dynamic key <1> OR <3> OR <5>, the display obtained for Daily
Quality Control Report for C1/C2/C3 respectively is as follows.

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Printout of the daily quality control report for C1 can be obtained using the dynamic
< PRINT > key. For selective display of quality control the < DATA > key can be
used.
By pressing < DATA > the last five results for the day of quality control are
displayed. Any of the points which are not in the control range can be selected by
< n > and < p > and deleted by the use of < ERASE ALL >or < ERASE > key.

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8.1.3. MONTHLY QUALITY CONTROL


It is a plot of standard deviation (Y-axis) against the number of days in a month (X-
axis). Data for each run (QC) is graphically plotted on LEVY –JENNINGS control
chart for the each chemistry 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/C3) run.
After the pressing dynamic key <2> OR <4> OR <6>, the display obtained for
Monthly Quality Control Report for C1/C2/C3 respectively is as follows.

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Printout of the monthly quality control Report can be obtained using the dynamic
<PRINT> key.
For selective display of quality control the <DATA> key can be used. By pressing
<DATA> the last 31 days results of quality control are displayed. Any of the points
which are not in the control range can be selected by < n > and < p > and deleted
by the use of < ERASE ALL >or < ERASE > key.

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8.2. COLLATED REPORTS


Reports can be obtained by pressing the dynamic key <REPORT> 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.

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Operator Manual CHEM-7

8.2.1. COLLATED REPORT BY DATE


The screen for Patient Report by Date is as follows:

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Operator Manual CHEM-7

8.2.2. COLLATED REPORT BY I.D

8.2.3. PATIENT REPORT BY DATE AND I.D


This allows the user to view report on basis of the date as well as the patient I.D.

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8.2.4. PATIENT REPORT BY DATE AND TEST

When dynamic key <ENTER> is pressed, the analyzer searches for the report by
selected parameters and the report is displayed. If no matching report is found,
message is displayed such as “NO REPORT FOUND”.
When <PRINT> key is pressed, these reports are printed on thermal printer or
USB printer or both as per the printer selection in SYSTEM SETUP > SYSTEM
PARAMS > MODE menu.

8.2.5. PATIENT REPORT ON EXTERNAL PRINTER


This option allows the user to take report on external USB printer. User can enter
patient demographics with PC/AT keyboard as well as Analyzer keyboard.

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1. Enter six digits alphanumeric Sample ID. These digits can be keyed in using
analyzer keypad or external keyboard.
2. To move up or down use external keyboard up n and down arrow p keys
provided on the external keyboard (DO NOT USE NUMERIC KEYPAD
SECTION OF THE EXTERNAL KEYBOARD).
3. Following is the character (alphanumeric) length provided to enter
information. For patient ID: 10 , Patient Name:23 , Age:3, Sex:6, Sample
Type:10, Sample Remark : 10 , Patient Remark:10 , Referred By: 23 ,
Analyst:23.
4. Once the required details are entered, user can press dynamic key
<ENTER>. The report is displayed as follows.

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Operator Manual CHEM-7

5. Selective reports can be printed on USB printer. Use key <SELECT> to


select report. When <PRINT> key is pressed, only selected reports are
printed.

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9. MAINTENANCE
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.

9.1. SELF TEST


This key is used to check the analyzer in “self-diagnostic” mode and is mainly used
by the Service Personnel. Following things can be done or checked in this menu.
1. Pump Calibration can be done.
2. Default parameters can be downloaded.
3. Flowcell temperature can be checked.
4. Pre and Log channel values for each filter can be checked.
5. Thermal Printer can be checked.
6. Unit keypad can be checked.

9.2. PUMP CALIBRATION


This function of the analyzer is used to calibrate the pump for aspirating specific
volumes from 200-999 μl. This facility is available in the ‘SELF TEST’ mode of
operation.

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To minimize error in pump calibration the initial air gap in the peristaltic tube is
removed by giving compulsory wash. The aspiration key is active only after wash
is performed.

To perform pump calibration press the dynamic key <SELF TEST > in SYSTEM
SETUP menu and then select pump calibration using the down arrow key.

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Take 1 ml of DI water in a test tube. Press <ASP> switch to start aspiration and
when the last drop is left in the tube, press <ASP> switch again. Now the
peristaltic pump is calibrated to aspirate any volume from 200 μl up to 999 μl.

9.3. DAILY MAINTENANCE


1. Wipe off any reagent spills on the analyzer immediately.
2. After every chemistry run, wash the flowcell thoroughly with good quality DI
water using the dynamic key <WASH> or <ASP> switch.
3. Always leave the flowcell filled with DI water. Never leave any reaction
mixture in it.
4. At the end of each day, aspirate neutral cleaning solution into the flowcell
and leave it filled overnight. Every morning aspirate DI water 5 ml to
thoroughly rinse the flowcell.
5. Empty the waste solution bottle every evening.
Caution: DO NOT USE STRONG ACIDIC OR ALKALINE
SOLUTIONS WHICH CAN CAUSE IRREPARABLE DAMAGE TO
THE ANALYZER.
Caution: DO NOT LEAVE THE FLOWCELL DRY. ALWAYS LEAVE
IT FILLED WITH DEIONIZED WATER DURING THE DAY AND
WITH CLEANING SOLUTION AT NIGHT.
NOTE: It is advisable to carry out the peristaltic pump calibration every week in
order to compensate for the change in elasticity of the tubing.

9.4. 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 errors of aspiration volumes and can also damage the
analyzer due to the leakage of corrosive reagents through torn
tubing.
Besides the above, certain other simple maintenance operations have to be
performed as and when required.
These are:
z Replacement of the paper roll
z Replacement of tubing

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Operator Manual CHEM-7

9.5. REPLACEMENT OF TUBING


Warning: THE REPLACEMENT OF ASPIRATION AND
PERISTALTIC TUBINGS SHOULD BE PERFORMED BY THE
TRAINED PERSON ONLY.
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.

9.5.1. ASPIRATION TUBE REPLACEMENT


1. Open the Photometer Cover.

2. Gently remove the flow cell from cuvette housing.

3. Unscrew the aspiration tubing from the flow cell.

9-4
Operator Manual CHEM-7

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 bio-


hazardous.
6. Slide 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 its slot.
9. Pass the end of the aspiration tube through the holder and pull it out so that
the length is adequate.
10. Aspirate the DI water.
11. Close the Photometer Cover.
NOTE: Take care to see the side of the flowcell with the arrow mark is in light path
and to your left. Also, whenever the flowcell is not in use, fill flowcell with DI water.

9.5.2. REPLACEMENT OF PERISTALTIC PUMP TUBINGS


1. Remove the Cover of the 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.

9-5
Operator Manual CHEM-7

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

5. Discard the old tubing onto an appropriate location, as it may be bio-


hazardous.
6. Position the new tubing around the rotor in right manner (as previous).
7. Insert the one end of new peristaltic tubing assembly into the tubing coming
from flow cell.
8. Insert the other end of peristaltic tubing into the waste tube and direct the
waste tube towards waste bottle.
9. Put the free end into the waste solution bottle.
10. Perform pump calibration with 1 ml DI water.
11. Put the Cover of the peristaltic pump housing.

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Operator Manual CHEM-7

9.6. REPLACEMENT OF LAMP ASSEMBLY


Warning: THE REPLACEMENT OF LAMP ASSEMBLY SHOULD
BE PERFORMED BY THE TRAINED PERSON ONLY.

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.

5. Unscrew the thumbscrew provided on the lamp holder.

9-7
Operator Manual CHEM-7

6. Pull out the lamp.

7. Place a new lamp and connect the lamp terminals and fix thumbscrews.
8. Refit the lamp cover.
9. Close Photometer 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.
Warning: SWITCH OFF THE POWER SUPPLY BEFORE
REMOVING THE COVER.

9.7. REPLACEMENT OF PRINTER PAPER


Warning: THE REPLACEMENT OF PRINTER PAPER SHOULD
BE PERFORMED BY THE TRAINED PERSON ONLY.

Before starting the instrument, make sure that enough printer paper is on the roll.
The paper roll is located under the printer cover. To check and / or replace 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.

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Operator Manual CHEM-7

4. Cut the paper in ‘V’ shape and 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: BE CAREFUL - SHARP PAPER CUTTER.

9-9
Operator Manual CHEM-7

This Page is Intentionally Left Blank

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Operator Manual CHEM-7

10. TROUBLE SHOOTING GUIDE


SERIAL SYMPTOM LIKELY CAUSE/CORRECTIVE ACTION
NUMBER
1 Liquid is not aspirated when the 1. Check if peristaltic pump tubing is connected
Dynamic key <WASH> switch properly, if not reconnects correctly.
is pressed 2. Perform pump calibration again.
3. Call Service Engineer
2 Liquid is not aspirated when the 1. Check if peristaltic pump tubing is connected
(ASPIRATE) “ASP” switch is properly. If not, reconnect it correctly.
pressed 2. Perform pump calibration again.
3. ASP switch is defective.
4. Call Service Engineer.
3 Peristaltic Pump operates but 1. Ensure that tubings are properly connected.
liquid is not aspirated. 2. Check tubing for blockage, crimps or leaks.
3. Perform pump calibration again.
4. Replace tubings.
5. Call Service Engineer.
4 Thermal Printer does not work. 1. Make sure that the paper roll is installed
properly with the heat sensitive surface up.
(The analyzer will not print if the paper is
fed reverse).
2. Check if paper is thermal paper as per the
specifications.
3. Ensure thermal printer option is selected in
system setup.
4. Check printer lever locking arrangement. It
should be in closed position.
5 Internal thermal printer works 1. Ensure external printer option is selected in
but external printer does not system setup.
work. 2. Ensure that attached printer cable is
connected firmly using proper
communication cable.
6 The temperature attained in the 1. Ensure that the flow cell is completely
flow cell is not within ± 0.1º C of inserted in the slot in its proper position.
the selected temperature. 2. Solution whose temperature is very different
from the selected temperature should not
be introduced directly into the flowcell.
3. Refrigerated reagents should be allowed to
attain Room Temperature before use.
4. Call service engineer.
7 Poor reproducibility and erratic 1. Check if the aspiration volume is
readings. programmed and whether the amount of
liquid aspirated is as programmed.
2. If the aspiration is not proper calibrate pump.
3. Check expiry date of the reagent and control
material used.

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Operator Manual CHEM-7

SERIAL SYMPTOM LIKELY CAUSE/CORRECTIVE ACTION


NUMBER
4. Check if all the necessary precautions have
been taken. Always use clean glassware.
5. Check flowcell for air bubbles.
6. Call service engineer.
8 Control values not within range 1. Ensure that the procedures specified by the
reagent manufacturer are followed.
2. Check the wavelength, temperature, sample
and reagent volumes, factor and standard
concentration. In case of kinetic chemistries
make sure that delay time, Read time, and
Read number are correctly programmed.
3. Ensure that the water for the reconstitution
of dry reagent is of reagent grade quality
i.e. DI water.
9 The result printout is 1. The initial absorbance of reaction mixture is
accompanied by the warning less than the ABS MIN. value in test
“CRITICAL REAGENT parameters.
ABSORBANCE” in all 2. Check if the “RG.ABSLIM” value has been
chemistries correctly entered.
3. Prepare fresh reagent and repeat the test.
10 The result printout is 1. The value of the sample is greater than the
accompanied by a warning value fed as “LIN.LIM”
message “HYPERACTIVE 2. The kinetic reaction is still in LAG phase as
SAMPLE!!” the amount of enzyme in the measurement
solution is very low.
3. Check if the initial absorbance is O.K.
4. Dilute the sample and perform the test
again. Multiply the result by the dilution
factor.
11 The analyzer gives continuous 1. Check the lever position for the printer.
beep 2. Check if there is sufficient paper in the
printer housing.
3. Check for the print mode in the system
setup, it should be either in AUTO
PRINTOUT or NO OUTPUT mode when
not connected to a computer.
4. Call service engineer.
12 Analyzer working but suddenly 1. Check for any heavy fluctuation in mains
LCD display becomes faint and supply. Should not be more than +/-10%.
alphanumeric characters are 2. Check loose connection of mains cable or
not seen. DC jack pin.
13 Halogen Lamp Blinking. 1. Check for any heavy fluctuation in mains
supply. Should not be more than +/-10%.
2. Check loose connection of mains cable or
DC jack pin.
3. Check loose connection of lamp lug fitting
screws.

10-2
Operator Manual CHEM-7

SERIAL SYMPTOM LIKELY CAUSE/CORRECTIVE ACTION


NUMBER
14 The result printout is 1. The initial absorbance of reaction mixture is
accompanied by the warning greater than the ABS MIN. value in test
“RX ABS LIM OVER” in all parameters for increasing chemistry
chemistries 2. Check if the “RX.ABSLIM” value has been
correctly entered.
3. Prepare fresh reagent and repeat test.
15 The result printout is 1. The initial absorbance of reaction mixture is
accompanied by the warning less than the ABS MIN. value in test
“RX ABS LIM UNDER” in all parameters for decreasing parameters
chemistries. 2. Check if the “RX.ABSLIM” value has been
correctly entered.
3. Prepare fresh reagent and repeat the test.
16 All readings are zero. 1. Check if the lamp is ON.
2. Check if the flowcell is placed in the light
path of the cuvette.
3. Call service engineer.
17 Test Parameters lost. Go to self-test and download parameter.
18 External keyboard is not Check PS/2 cable connected to the rear panel
working of the analyzer.
19 Keypad is locked 1. Reset the analyzer by switching OFF power.
2. Check if the aspiration switch is pressed.
3. Call service engineer.
20 Hardware check shows 1. Check if flowcell is empty or free from air
photometer is NOT O.K. bubbles.
message displayed on LCD 2. Check if flowcell is properly inserted in the
flowcell housing.
21 Hardware check shows SMPS 1. Go to self-test and check if outside range
voltage NOT O.K. 2. Call service engineer.

22 Hardware check shows Call service engineer.


memory NOT O.K.
23 Analyzer does not switch ON 1. Check mains cord properly inserted in mains
socket/ power adaptor plug.
2. Check if adapter DC power cable is
connected properly.
24 Paper key does not advance 1. Check for presence of the paper.
the paper. 2. Release printer lever.

10-3
Operator Manual CHEM-7

This Page is Intentionally Left Blank

10-4
Operator Manual CHEM-7

11. LIST OF CONSUMABLES


For continuous and trouble free working of analyzer, 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
OEM packing until the actual use.
SERIAL ITEM CODE DESCRIPTION UNIT/QUANTITY
NUMBER
1 110021 ASSEMBLY PERISTALTIC TUBE 02 NOS.
2 111213 TUBE TEFLON 0.75MM X 1.5MM (442- 0.21 MTR
5409-4)
3 110018 ASSEMBLY LAMP 1 NO.
4 110309 THERMAL PAPER ROLL (57 MM X 30 3 NOS.
M) FOR PRINTER
5 110347 MICRO CUVETTE RECTANGULAR 10 NOS.
POLYSTYRENE
6 110945 CUVETTES ROUND GLASS MICRO ID 10 NOS.
6 MM OD 8 MM
7 120232 ERBA WASH (4 X 50ML) 1 NO.

11-1
Operator Manual CHEM-7

This Page is Intentionally Left Blank

11-2
Operator Manual CHEM-7

12. ANNEXURE
12.1. RESULT TRANSMISSION PROCEDURE USING
USB CABLE
Steps to be Followed Expected Output
1. Connect the B type plug of USB cable to the B "New Hardware Found" message should Pop Up
type USB receptacle at the rear of instrument on the PC once Chem7 New scheme m/c is
and Connect the A type plug of USB cable to connected.
the A type USB receptacle on the PC.
2. Switch ON the instrument

1. Right click on "My Computer" icon. A virtual COM Port with the name "USB to Serial
2. Click on "Properties". Port" should be displayed among other COM and
LPT ports.
3. Select "Hardware" tab (Step not required for
Win 98 OS).
4. Select Device Manager button/tab.
5. Click on check box of "Ports (COM & LPT)".
1. Open Hyper Terminal (or any other COM port The result of the Chemistry along with Sample ID and
monitoring software) with the following Setting: appropriate flags must be displayed on the window of
a) Baud rate : 19200 bps the Serial Port monitoring software (Hyper Terminal).
b) Data Bits :8
c) Parity : None
d) Stop Bits :1
e) Flow control : None
Note: Make sure to open the Virtual COM port in
Hyper Terminal which was created in step 1.2
2. Run a chemistry

12-1
Operator Manual CHEM-7

12.2. RESISTANCE VERSUS TEMPERATURE


RESISTANCE VERSUS TEMPERATURE -40ÛC to +150ÛC
Tem RES Tem RES Temp RES Tem RES Temp RES in Temp RES Tem RES
pÛC in ƻ pÛC in ƻ ÛC in ƻ pÛC in ƻ ÛC ƻ ÛC in ƻ pÛC in ƻ

-40 3356k -10 565.5k 20 125.5k 50 34.70k 80 11.54k 110 4427 140 1914
-39 3147k -9 535.6k 21 119.0k 51 33.44k 81 11.15k 111 4297 141 1865
-38 2951k -8 507.5k 22 114.5k 52 32.15k 82 10.70k 112 4172 142 1817
-37 2769k -7 481.0k 23 109.4k 53 30.82k 83 10.42k 113 4051 143 1770
-36 2599k -6 456.0k 24 104.5k 54 29.74k 84 10.08k 114 3933 144 1725
-35 2440k -5 432.4k 25 100.0k 55 28.61k 85 9744 115 3820 145 1681
-34 2292k -4 410.0k 26 95.51k 56 27.53k 86 9424 116 3711 146 1639
-33 2154k -3 389.2k 27 91.34k 57 26.50k 87 9117 117 3605 147 1598
-32 2025k -2 369.4k 28 87.38k 58 25.50k 88 8821 118 3502 148 1558
-31 1904k -1 350.7k 29 83.60k 59 24.58k 89 8536 119 3403 149 1519
-30 1791k 0 333.1k 30 80.00k 60 23.65k 90 8281 120 3307 150 1481
-29 1685k 1 316.4k 31 76.58k 61 22.77k 91 7996 121 3214
-28 1588k 2 300.6k 32 73.32k 62 21.94k 92 7741 122 3124
-27 1494k 3 285.7k 33 70.22k 63 21.14k 93 7496 123 3038
-26 1407k 4 271.6k 34 67.26k 64 20.37k 94 7259 124 2953
-25 1326k 5 258.3k 35 64.44k 65 19.63k 95 7030 125 2872
-24 1250k 6 245.7k 36 61.75k 66 18.93k 96 6810 126 2793
-23 1178k 7 233.8k 37 59.19k 67 18.25k 97 6598 127 2717
-22 1111k 8 222.5k 38 56.75k 68 17.60k 98 6393 128 2643
-21 1049k 9 211.9k 39 54.42k 69 16.97k 99 6195 129 2571
-20 989.8k 10 201.7k 40 52.19k 70 16.37k 100 6005 130 2501
-19 934.6k 11 192.2k 41 50.07k 71 15.80k 101 5821 131 2434
-18 882.7k 12 183.1k 42 48.04k 72 15.25k 102 5643 132 2369
-17 834.0k 13 174.5k 43 46.11k 73 14.72k 103 5472 133 2306
-16 788.2k 14 166.3k 44 44.26k 74 14.21k 104 5307 134 2244
-15 745.2k 15 158.6k 45 42.50k 75 13.72k 105 5147 135 2185
-14 704.7k 16 151.3k 46 40.81k 76 13.25k 106 4993 136 2128
-13 666.7k 17 144.3k 47 38.20k 77 12.79k 107 4844 137 2072
-12 630.9k 18 137.7k 48 37.66k 78 12.36k 108 4700 138 2018
-11 597.2k 19 131.4k 49 36.19k 79 11.94k 109 4561 139 1965

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Operator Manual CHEM-7

13. REVISION HISTORY


Revision Date Revision Description Author
2011.01 21-May-2011 First release Prasad Patil
2012.01 17-March-2012 Added Air Purge feature & Released Prasad Patil
2012.01.01 17-Oct-2012 Introduced section wise page numbering & Prasad Patil
added note for compatible software version
number.

*
Compatible Software Version: 2012.01.xx

*
NOTE: xx denotes intermediate software releases having no impact on this Operator Manual.

13-1

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