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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.
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Operator Manual CHEM-7
Legal Information
All rights are reserved by manufacturer of this product.
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.
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.
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Operator Manual CHEM-7
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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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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DISPLAY KEYPAD
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EXTERNAL KEYBOARD
EXTERNAL PRINTER
PORT
DC INPUT SUPPLY
PERISTALTIC PUMP COVER
CONNECTOR
ON/OFF SWITCH
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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:
18 μl Flow cell or 33 μl (optional)
10 mm square cuvette
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.
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I.D.
By Date and I.D.
By Date and Test Name.
z Graphic presentation of Non Linear calibration curves.
z QC (Levy Jennings Chart available for three controls per test)
Daily QC.
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:
Selectable Delay Time between 5 seconds and 999 seconds.
Selectable Read Time between 5 seconds and 999 seconds.
Selectable Read Number between 5 seconds and 999 seconds.
z Non-linear calibration (10 Standards including Zero Standard) with 3
methods.
Point to Point.
Spline.
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.
KEY DESCRIPTION
There are 6 dynamic keys, which are LCD display
screen specific.
TO
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Operator Manual CHEM-7
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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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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Operator Manual CHEM-7
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.
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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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4.6.3. PC COMMUNICATION
NOTE: USB Connectivity to PC requires operating system 2000/XP or above.
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5. PRINCIPLES OF OPERATION
5.1. MODES OF OPERATION
The analyzer is capable of performing analysis using the following modes.
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z Rate A Nonlinear
z Sample Blank Nonlinear
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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.
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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.
Date.
ID.
Date and ID.
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.
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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.
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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.
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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.
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Operator Manual CHEM-7
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.>
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Operator Manual CHEM-7
After entering all the parameters of the equation, press key <CALC> to calculate
the result.
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Operator Manual CHEM-7
After this screen appears press the dynamic key ‘< ENTER >’ so that the numbers
are displayed along with the test name as shown below:
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Operator Manual CHEM-7
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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Operator Manual CHEM-7
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>.
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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Operator Manual CHEM-7
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.
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7. MODES OF OPERATION
Refer chapter 5 for test parameters before performing any TEST.
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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.
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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:
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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>.
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Operator Manual CHEM-7
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
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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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Operator Manual CHEM-7
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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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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Operator Manual CHEM-7
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).
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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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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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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).
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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:
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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.
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Press the appropriate number key to select the required analysis code, and then
press ENTER.
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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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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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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.
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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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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.
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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.
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Operator Manual CHEM-7
4. Slide out the washer and ‘O’ ring of the old aspiration tubing.
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.
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Operator Manual CHEM-7
4. Detach both the ends of the tubing from Aspiration tubing and Waste tubing
respectively.
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Operator Manual CHEM-7
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.
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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.
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.
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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
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-40 3356k -10 565.5k 20 125.5k 50 34.70k 80 11.54k 110 4427 140 1914
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*
Compatible Software Version: 2012.01.xx
*
NOTE: xx denotes intermediate software releases having no impact on this Operator Manual.
13-1