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Z-Delite S
Z-Delite S Operator Manual
Foreword
This manual is created with the purpose of providing a reference for easy operation and
general maintenance of this analyzer. It contains detailed description of the analyzer
features, specifications and maintenance activities.
Use of the analyzer with proper knowledge will ensure proper test results and trouble
free analyzer operation with optimum performance.
This operation manual is prepared based on the assumption that the user has prior
knowledge of clinical chemistry.
Before operating the analyzer, user should:
1. Thoroughly read and understand this manual.
Contact Us
We welcome your feedback about the analyzer. You can reach us via the following
contact details,
German Subsidiary
Zovec Diagnostics GmbH
Mühlenstraße 8a, 14167
Berlin, Germany
Table of Contents
1. OVERVIEW OF ANALYZER........................................................................................................... 6
1.1. INTRODUCTION ....................................................................................................................... 6
1.2. ANALYZER VIEW .................................................................................................................... 7
1.3. KEYPAD ..................................................................................................................................... 8
1.4. ASPIRATION SWITCH ............................................................................................................ 9
2. SAFETY ............................................................................................................................................ 10
2.1. GENERAL SAFETY ............................................................................................................... 10
3. SYSTEM SPECIFICATIONS AND FEATURES ........................................................................ 11
3.1. SOFTWARE SPECIFICATIONS .......................................................................................... 12
4. INSTALLATION .............................................................................................................................. 14
4.1. INSPECTION ........................................................................................................................... 14
4.2. UNPACKING ........................................................................................................................... 14
4.3. INSTALLATION REQUIREMENTS ..................................................................................... 15
4.4. ELECTRICAL REQUIREMENTS ......................................................................................... 15
4.5. INSTALLATION PROCEDURE ............................................................................................ 16
4.6. PRINTER AND INSTRUMENT COMMUNICATION INSTALLATION ........................... 16
5. PRINCIPLES OF OPERATION .................................................................................................... 17
5.1. MODES OF OPERATION ..................................................................................................... 17
5.2. READING THE FLOWCELL/CUVETTE ............................................................................. 18
5.3. CARRYOVER AND ASPIRATION VOLUME .................................................................... 18
5.4. CALCULATION OF THE KINETIC TEST RESULTS ....................................................... 19
5.5. ADDITIONAL CUVETTE HOLDER ..................................................................................... 19
6. SCREEN NAVIGATION ................................................................................................................. 20
6.1. POWER ON MENU ................................................................................................................ 20
6.2. HOME SCREEN MENU ......................................................................................................... 21
6.3. SETUP ...................................................................................................................................... 23
6.4. ASSAY NAME GENERATION ............................................................................................. 26
6.5. SETTING OF PARAMETERS............................................................................................... 26
7. MODES OF OPERATION ............................................................................................................. 28
7.1. END POINT LINEAR MODE ................................................................................................. 28
7.2. FIXED TIME LINEAR MODE ................................................................................................ 32
7.3. KINETIC (RATE) LINEAR MODE ........................................................................................ 33
7.4. SAMPLE BLANK LINEAR MODE ....................................................................................... 33
7.5. END POINT NON LINEAR MODE ....................................................................................... 33
7.6. FIXED TIME NON LINEAR MODE ...................................................................................... 33
7.7. RATE NON LINEAR MODE.................................................................................................. 34
7.8. COAGULATION MODE ......................................................................................................... 34
1. OVERVIEW OF ANALYZER
1.1. INTRODUCTION
There are 10 modes of operation. Assay Programming, Results reading and reporting
operations are user friendly.
Operation is through a soft-touch keypad (or a USB mouse/keyboard) with quick shift
from one function to another without going through complex sequential operations.
The analyzer is provided with an user friendly and easy to operate GUI which is further
enhanced by the provision of a 800x480 dots colour TFT display with LED backlight;
with alphanumeric and graphic capabilities.
The analyzer has memory for storage of all Assay Parameters including Reagent Blank
Absorbance, Factor, Non-linear Calibration Data. A patient-wise collated report is
obtained upon request. Exhaustive quality control data at 4 levels, for any of the tests is
also stored in the memory of the analyzer.
The analyzer software provides device diagnostics with Maintenance function, which is
capable of providing timely flag / error messages related to test results or analyzer
malfunctioning.
1.3. KEYPAD
KEY DESCRIPTION
There are 8 dynamic function keys,
which are TFT display screen specific
Numeric Keys from 0 to 9, they are
used to enter
TO
There are 30 multifunction keys, which
act as 60 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 A1C gets activated.
The same key is used to enter the
alphabets from ‘A’ to ‘Z’, special
characters ‘@’ , ‘%’, ‘(‘, ‘)’ and ‘a’ to ‘z’,
special characters ‘#’, ‘&’, ‘*’, ‘/’
indicated on the right side 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.
The Aspiration Switch Actuator is located at centre of the instrument below the
aspiration tube which is provided for aspiration of liquid into the flow cell and for
washing flow cell.
2. SAFETY
This section provides safety information about analyzer. Use this product properly
and safely to prevent injuries and or damage to instrument/property. User must read
these safety precautions before installation/use and follow the directions.
b) While operating, maintaining, servicing or repairing the analyzer, follow all the
procedures described in this manual.
e) Never use substitute parts on the analyzer or modify it in any waywithout the
written consent of the manufacturer.
i) Take necessary precautions against hazards associated with the use of clinical
laboratory chemicals and reagents. Wipe any reagent spillage on the analyzer
immediately.
4) Facility to memorize reagent blank O.D., Standard O.D., Factor and Nonlinear curve
for 10 Standards including Standard 0.
5) Patient report up to 6 months can be stored in memory and can be obtained by,
a) I.D.
b) Date.
c) Test Code
d) By I.D. and Date
e) By Test Code and Date.
6) Levy Jennings Graph for Daily and Monthly QC (available for 4 levels of controls per
test).
8) Five fixed calculation formulas for calculation of certain parameters from the
previously run chemistry results.
12) Up to 10 Standards (including Standard Zero) for Non-linear tests with calibration
and graphs by 4 methods,
a) Point to Point.
b) Exponential.
c) Cubic Spline.
d) Logit Log.
20) Printout can be obtained on USB Printer or/and Thermal Printer by using PRINT
key.
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 are packed in another carton. The authorized
representative is responsible for unpacking, installing and initial setting up of the
analyzer.
Installation check list:*** Please refer to dispatch note for detailed checklist.
Optional Accessories
1 ZOM-00090 Adjustable Volume Pipette 5-50ml 1
2 ZOM-00091 Adjustable Volume Pipette 100-1000ml 1
3 ZOM-00092 Pipette Stand 1
4 ZOM-00093 Pipette Tips series 200ul Yellow 100
5 ZOM-00094 Pipette Tips series 1000ul Blue 100
6 ZOM-00095 Incubator Assembly 1
7 ZOM-00096 Test Tube Stand 1
8 ZOM-00097 Demo kit 1
Remember that minimum 30 cm. space should be maintained between the rear panel
and the wall to allow for heat dissipation. Also the ventilation present at the rear and
bottom of the instrument should not be blocked as it is required for proper Air
circulation.
Please ensure while taking any electrical measurement, the multimeter used must
have been calibrated and should possess valid calibration identification traceable
to National/International standards.
PROBLEM/s resulting from the relocation of the analyzer done by unauthorized service
representative are not covered under warranty.
Note: Installation should be done by properly trained personnel only.
Always ensure that the ON/OFF switch is easily accessible to the user in case of
emergency switch OFF.
Heavy-duty electrical devices like Air conditioners, refrigerators, oven’s etc., should not
be operated on the same electrical lines as the analyzer.
3. Direct the peristaltic pump tubing coming out from the analyzer into the waste
bottle.
4. The analyzer comes equipped with an external power adapter and one three/two
pin power cord (with earth terminal) for Mains supply.
5. Connect the 3/2 pin cord (with earth terminal) of the external power adaptor to
the mains socket and check the output of the adaptor, it should be within ± 0.5 V
range.
6. 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.
4.6.3. PC COMMUNICATION
USB B Type connector is provided for PC Communication and Debug Purpose.
5. PRINCIPLES OF OPERATION
The analyzer works on the Beer – Lambert’s Law which state’s that “In absorbance
spectrophotometer, when the light is incident on the colored solution the amount of light
absorbed is directly proportional to the concentration of the solution with the constant
path length”
A concentrated beam of light is passed through filter and is incident on flow cell.
Amount of light transmitted through the flow cell is measured by the photometer. This
signal is further amplified and converted into digital form for data processing and
analysis.
For Rate A and Two Point mode, extra air(maximum upto 500 μl) is aspirated after
displaying the result. However, the Air Purge between samples is optional and the
same can be enabled/disabled from System Setup Menu.
NOTE: It is recommended to use an aspiration volume of at least 400 μl for better
accuracy and minimize carryover.
6. SCREEN NAVIGATION
6.1. POWER ON MENU
Switch ‘ON’ the analyzer. After Power ON software Loading processes, it will display
the Zovec Healthcare Private Limited company’s LOGO for 5 seconds.
Then 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 and the
flowcell needs to be filled with DI Water while switching ON the instrument or else all
the photometer filters will be shown NOT OK in Initialization Process Check screen.
If all the initialization checks are OK then automatically the Home Screen will be
displayed.
This screen is also referred to as the “Home screen” of the analyzer. This menu
is used for the selection of test, viewing/programming of test parameters, obtaining QC
data, searching of previous results/reports, running a Maintenance check, programming
System settings or shutting down the instrument.
Select any one of the options in Home screen by pressing corresponding number
‘< 1 to 8 >’ on the Keypad or by navigating through arrow Keys and then selecting by
pressing ‘< ENTER >’.
Each sub-menu is described below.
6.2.2. PROGRAM
This menu is used to view, print and edit, appropriate parameters of selected chemistry
including,
Control values (Mean and SD) for 4 levels of controls
Normal minimum and maximum ranges for multiple Patient types
(Male/Female/Infant/General)
6.2.4. SEARCH
Patient-wise report of all chemistries runs for a particular sample identified by
the following parameters.
a) ID.
b) Date.
c) Test Code
d) I.D. and Date
e) Test Code and Date
6.2.5. MAINTENANCE
For self-diagnostics tests.
6.2.6. SETUP
To set the Printer settings, System settings, Lamp Control settings and Laboratory
information.
6.2.7. ABOUT US
This menu displays the contact information about Zovec Healthcare Private Limited.
6.2.9. 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.
6.3. SETUP
The setup menu allows the user to view, edit the Printer Settings, System Settings,
Lamp Control Settings and Lab Information. Select any one of the options in SETUP
screen by pressing corresponding number ‘< 1 to 4 >’ on the Keypad or by navigating
through arrow Keys and then selecting by pressing ‘< ENTER >’.
The “SETUP” screen is as follows:
To create a new assay code, choose ‘< OTHER TESTS >’ in the Program Test List
page. To add a new assay code press key.
7. MODES OF OPERATION
7.1. END 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.
2. After successful Baseline Test, the parameters necessary for operation in the mode
are as displayed on the screen.
4. 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 calculated and a
pop up message appears, “Do You want to save Blank Value?”
5. Use arrow keys to toggle between Yes/No keys. When ‘Yes’ key is selected and user
presses the ‘< ENTER >’ key then O.D. of 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.
6. Now if Standard is previously run and a factor is already obtained for the particular
Assay Test then the following pop up appears “Do you want to Run New
Calibration?”
7. Alternately press dynamic key ‘< CALIB >’ to aspirate standard. The analyzer then
displays “ASPIRATE STANDARD”, or as shown in the following screen.
8. Now 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, then the factor is calculated and pop up appears “Do you want to
save new factor?”
9. Use arrow keys to toggle between Yes/No keys. When ‘Yes’ key is selected and user
presses the ‘< ENTER >’ key then the new factor is memorized. The factor obtained is
now displayed against the FACTOR on the Screen. Steps 4 and 5 can be skipped if
factor is entered or predefined in test parameters.
10. Now press dynamic key ‘< SAMPLE >’ to perform samples. The following screen is
displayed,
12. Perform the sample run, 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 and the concentration is calculated.
13. User has to enter sample type (Male /Female / Infant / General) to give the flag as
per the normal ranges for each type. If Auto Print is turned ON then the result is directly
printed.
15. The display will show the absorbance as well as the concentration of each sample,
its net absorbance. A printout of the result is obtained either automatically or by using
the dynamic <PRINT> key.
16. Re-reading of the currently aspirated sample is performed through the ‘< RETEST
>’ key. function
17. After aspiration of each sample, message will be displayed to withdraw tube after
which air will be aspirated. The amount of air aspirated is user defined.
16. After all readings are taken, press the ‘< PREV >’ or ‘< HOME >’ key to return to the
“Test List” or “Home Screen” or press direct access key of another test to be performed
next. Before the selected screen appears the following message will appear “Perform
WASH operation to rinse Flowcell thoroughly, Aspirate 4-5 ml DI water, Select WASH to
Start”. Perform Wash by pressing the dynamic Key ‘< WASH >’.
2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Select the
<Sample I.D> by pressing UP/DOWN keys and then edit the Sample I.D. by using
Alphanumeric keys or scanning a Barcode with the interfaced Barcode Reader.
4. Perform the sample run, the analyzer will automatically start incubation countdown
(entered as Delay time in parameters). At the end of delay time the analyzer will
automatically start with Read time countdown; and also store the absorbance of the
sample at the start of Read Time countdown as Initial Absorbance. At the end of Read
Time countdown it will once again store the absorbance of the sample as Final
Absorbance. The analyzer will then subtract the two absorbance readings and give the
net Absorbance along with the concentration of the analyte in the sample.
5. Follow steps 13 to 16 from section 7.1 to perform repeated Samples or to exit from
the Test run.
2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.
3. Follow steps defined in section 7.1 to perform repeated Samples or to exit from the
Test run.
2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.
2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.
2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.
2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.
2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.
2. When ‘< SAMPLE >’ key is pressed, the sample run screen appears. Enter Sample
I.D and then perform the sample test.
8. 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 4 levels of controls for 31 days, for all the 200 tests.
The target/mean value and the range/SD (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.
Select the appropriate Test/Assay code by using Arrow keys and press ‘< ENTER >’.
The display changes to the following screen.
Year: 2021 Page 35 of 59
Z-Delite S Operator Manual
Printout of the daily quality control data for any level can be obtained using the dynamic
< PRINT > key.
Any of the points which are not in the control range can be selected by Arrow Keys and
deleted by the use of < DEL > key.
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 level(L1/L2/L3/L4) run.
After the pressing dynamic key ‘< DATA >’, the last 31 days results of quality control
are displayed and the display obtained for Monthly Quality Control Report for
L1/L2/L3/L4 respectively is as follows.
Printout of the monthly quality control Report can be obtained using the dynamic
<PRINT> key.
NOTE: Taking monthly QC report print is possible only if valid SD and Mean values are
defined.
9. SEARCH REPORTS
Reports can be obtained by pressing the numeric key < 4 > in the “Home
Screen”. It allows the printing of the results obtained in the analysis for each patient.
The Patient Report can be obtained by:
a) I.D.
b) Date
c) Test Code
d) I.D and Date
e) Test Code and Date.
Press dynamic key ‘< SEARCH >’ to display results by entered I.D.,
Press dynamic key ‘< SEARCH >’ to display results by entered Start and End Date,
Press dynamic key ‘< SEARCH >’ to display results by entered Test Code,
When dynamic key ‘< SEARCH >’ is pressed, the analyzer searches for the report by
selected parameters and the report is displayed.
When dynamic key ‘< SEARCH >’ is pressed, the analyzer searches for the report by
selected parameters and the report is displayed.
When dynamic ‘< PRNT >’ key is pressed, selected report is printed on thermal printer
or USB printer or both as per the printer selection in SETUP > PRINTER SETTINGS
menu.
When dynamic ‘< PRNT ALL >’ key is pressed, all reports are printed (on selected
printer).
10. 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.
10.1.1. Keypad
Working of individual Keys of the Keypad can be checked.
10.1.4. Photometer
Photometer counts of each filter can be checked.
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 2000 μl.
10.1.8. Backup
Backup can be obtained.
2. After every chemistry run, wash the flowcell thoroughly with good quality DI water
using the dynamic key <WASH>.
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.
4. Slide out the washer and ‘O’ ring of the old aspiration tubing.
6. Slide the washer and ‘O’ ring into the new aspiration tubing.
9. Pass the end of the aspiration tube through the holder and pull it out so that
the length is adequate.
2. Press the lock gently and Pull out the cassette of the peristaltic pump.
3. Insert a new cassette with new tubings inside the spindle and gently push so that
the locks are fastened.
5. Aspirate DI water and check for proper flow rate and leakages.
4. Place a new lamp and connect the lamp connector and then fix the screws.
6. Check the Photometer counts for all wavelengths in Home Screen >
Maintenance > Photometer menu.
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 after unlocking the Lid lock. For inserting a new paper
roll do as follows.
2. Lift off the printer cover and take the roll out of the paper roll housing.
3. Then take a new paper roll and lay down into the paper roll housing.
Serial
Item Code Description Unit / Quantity
Number
1 ZOM-00098 Peristaltic Pump Cassette 2